interessados.
relações de trabalho entre empregadores e trabalhadores representados pelas associações que as outorgaram que se dediquem ao comércio por grosso e ou à importação de material eléctrico, electrónico, informático, electrodomés- tico, fotográfico ou de relojoaria e actividades conexas, incluindo serviços.
As associações subscritoras requereram a extensão do contrato colectivo de trabalho referido aos empregadores não filiados na associação outorgante e que no território nacional exerçam a mesma actividade e aos trabalhadores ao seu serviço representados pelas associações sindicais outorgantes.
Não foi possível proceder ao estudo de avaliação de impacte da extensão da tabela salarial por a convenção reduzir o número de níveis salariais. Contudo, com base no apuramento dos quadros de pessoal de 2005, verificou-
-se que no sector abrangido pela convenção existem 11 043 trabalhadores, sendo 9200 a tempo completo, com exclusão de aprendizes e praticantes.
A convenção actualiza, ainda, outras prestações de con- teúdo pecuniário como o subsídio de refeição (25 %), o abono para falhas (12,9 %), o subsídio de turno (13,3 %) e outras ajudas de custo (14,5 %). Não se dispõe de dados estatísticos que permitam avaliar o impacte destas pres- tações. Considerando a finalidade da extensão e que as mesmas prestações foram objecto de extensões anteriores, justifica-se incluí-las na extensão.
Atendendo a que a convenção regula diversas condições de trabalho, procede-se à ressalva genérica de cláusulas contrárias a normas legais imperativas.
Com vista a aproximar os estatutos laborais dos traba- lhadores e as condições de concorrência entre as empresas do sector de actividade abrangido pela convenção, a ex- tensão assegura para a tabela salarial e para as cláusulas de conteúdo pecuniário retroactividade idêntica à da con- venção. No entanto as despesas de deslocação previstas no n.º 3 da cláusula 28.ª são excluídas da retroactividade por respeitarem a despesas já efectuadas.
Tendo em consideração a existência no sector de acti- vidade da presente convenção de outras convenções co- lectivas de trabalho outorgadas por diferente associação de empregadores, com âmbito parcialmente coincidente, assegura-se, na medida do possível, a uniformização do estatuto laboral em cada empresa.
Embora a convenção tenha área nacional, a extensão de convenções colectivas nas Regiões Autónomas compete aos respectivos Governos Regionais, pelo que a extensão apenas é aplicável no território do continente.
A extensão da convenção tem, no plano social, o efeito de uniformizar as condições mínimas de trabalho dos tra- balhadores e, no plano económico, o de aproximar as con- dições de concorrência entre empresas do mesmo sector. Foi publicado o aviso relativo à presente extensão no Boletim do Trabalho e Emprego, n.º 8, de 28 de Fevereiro de 2009, à qual não foi deduzida oposição por parte dos
interessados.
Assim:
Manda o Governo, pelo Ministro do Trabalho e da So- lidariedade Social, ao abrigo do artigo 514.º e do n.º 1 do artigo 516.º do Código do Trabalho, o seguinte:
Artigo 1.º
1 — As condições de trabalho constantes do CCT en- tre a AGEFE — Associação Empresarial dos Sectores Eléctrico, Electrodoméstico, Fotográfico e Electrónico
e a FEPCES — Federação Portuguesa dos Sindicatos do Comércio, Escritórios e Serviços e outros, publicado no Boletim do Trabalho e Emprego, n.º 37, de 8 de Outubro de 2008, são estendidas no território do continente:
a) Às relações de trabalho entre empregadores não fi- liados na associação de empregadores outorgante que se dediquem ao comércio por grosso e ou à importação de material eléctrico, electrónico, informático, electrodomés- tico, fotográfico ou de relojoaria e actividades conexas, incluindo serviços, e trabalhadores ao seu serviço das pro- fissões e categorias profissionais nele previstas;
b) Às relações de trabalho entre empregadores filiados na associação de empregadores outorgante que prossigam
a actividade económica referida na alínea anterior e traba- lhadores ao seu serviço das mesmas profissões e categorias profissionais não representados pelas associações sindicais outorgantes.
2 — Não são objecto de extensão as cláusulas contrárias a normas legais imperativas.
3 — O disposto no n.º 1 não é aplicável às empresas filiadas na Associação Portuguesa das Empresas do Sector Eléctrico e Electrónico.
Artigo 2.º
1 — A presente portaria entra em vigor no 5.º dia após a sua publicação no Diário da República.
2 — A tabela salarial e as cláusulas de conteúdo pecuniá- rio, com excepção das prestações previstas no n.º 3 da cláu- sula 28.ª, produzem efeitos a partir de 1 de Julho de 2008. 3 — Os encargos resultantes da retroactividade poderão ser satisfeitos em prestações mensais de igual valor, com início no mês seguinte ao da entrada em vigor da presente portaria, correspondendo cada prestação a dois meses de
retroactividade ou fracção e até ao limite de cinco.
O Ministro do Trabalho e da Solidariedade Social, Xxxx Xxxxxxx Xxxxxxx Xxxxxx xx Xxxxx, em 4 de Junho de 2009.
MINISTRY OF HEALTH
Decree-Law no. 145/2009
of 17 June
The legal regulations of medical devices comprise a scattered set of standards resulting from the ongoing technical and scientific progress as well as the need to adjust national legislation to the European union rules.
The obligation to transpose, to domestic legislation, of Directive no. 2007/47/CE, of the European Parliament and the Council of 5 September, which amends Directive no. 90/385/CEE, of the Council, o 20 June, regarding the approximation of the laws of the Member States regarding active implantable medical devices, Directive no. 93/42/CEE, of the Council, of 14 June, regarding medical devices, and Directive no. 98/8/CE, o the European Parliament and the Council, of
16 February, regarding the marketing of biocidal products, is the opportunity to include in the same statute the legal system applicable to all medical devices, including active implantable medical devices.
Given its specificity and the fact that medical devices for in vitro diagnosis are not covered by Directive n.º 2007/47/CE, of the European Parliament and the Council, of 5 September, they still are the object of autonomous regulations, notwithstanding some provisions of this decree-law applying to the mentioned devices.
This decree-law includes also specific provisions applying to medical devices manufactured using animal tissues, converting into national law Directive no. 2003/32/CE, of the Commission, of 23 April, and also governs National Surveillance System of Medical Devices, a subject which was under separate law.
Furthermore, clinical research of medical devices was provided for according to the amendments introduced by Directive no. 2007/47/CE, of the European Parliament and the Council, of 5 September, and also by means of the adaptation of the ethical principles included in the legal system of clinical trials of medicinal products for human use to clinical research of medical devices.
By means of this decree-law the manufacture and wholesale distribution of medical devices is from now on subject to the notification to the competent authority and the obligation for the applicant to have a pharmacy technician ensuring the quality of the activities carried out, the suitable facilities and equipment, so as to guarantee the compliance with the devices’ safety and performance requirements.
The minimum requirements regarding the manufacture of medical devices as well as the rules regarding good practices of wholesale distribution of medical devices are also to be approved by decree-order of the Minister of Health.
When converting into national law Directive no. 2007/47/CE, of the European Parliament and the Council, of 5 September, this decree-law takes in the objectives that supervised the approval of this directive.
Therefore, consistency with construing and applying to active implantable medical devices the legal system regarding such aspects as representatives, the European database, measures to protect public health and the scope of the statute enforcement is ensured with regard to the devices integrating human blood and plasma derivative products. The aim is a more consistent enforcement of public health protection measures, to guarantee, that the use of medical devices does not represent a hazard for the patients’ safety or health in particular.
There is also the aim to clarify that the software in itself is a medical device when specifically intended by the manufacturer to be used for one or several purposes established in the d e fin itio n o f th e med ical d evice; of ensuring that the reprocessing of medical devices does not represent a hazard for the patients’ safety and health by means of the clarification of the definition of the expression “sole use” the consistent labeling and instructions for use, the clarification that, in general, clinical data are required regarding all the devices, irrespective of its risk class; of the possibility to centralize all data regarding clinical researches within European data base.
The possibility of all manufacturers of sterile devices, or measurement devices of class I to use the full quality assurance module within the scope of the compliance assessment, is also provided, so as to allow them a greater flexibility when choosing compliance modules.
In the case of implantable devices, the period for keeping the records of documents is increased to, at least, 15 years.
The manufacturer with no registered office within the European Union is under the obligation to appoint a sole representative for each device, so that the competent authorities may question him, regarding issues related to the compliance of the devices.
As for transparency issues the access of any stakeholder or the public to certain information regarding the medical devices and their respective compliance with the provisions of this decree-law, in particular information regarding records, surveillance reports and certificates.
The manufacturer is also under the obligation, as for the essential requirements, to take into consideration the ergonomic design and to give more importance to the level of training and proficiency of the users, namely the non professional users, focusing particularly on the consequences of inappropriate use of the product and its adverse effects on the human body.
The validation of the software in the scope of medical devices in compliance with the state of the art, is imposed as an essential requirement, the manufacturer being also under the obligation to show that suitable controls are applied to the third parties contracted for the design and manufacture of the devices on its behalf, so as to keep on ensuring the quality system is being efficiently implemented.
The activities and powers of the notified bodies and the competent authority within the scope of the devices assessment requiring the intervention of the competent authorities with regard to medicinal products and human blood derivative products are also clarified.
When performing its tasks under the quality assurance and conformity checking modules for all classes of devices, the notified body is under the obligation to examine the design documents of the concerned medical device, so as to guarantee the manufacturer’s compliance with the applicable provisions, the thoroughness and extent of this examination being proportional to the risk class of the device, the innovation of the provided treatment, the intervention level, the innovation of technology or the building materials, as well as the complexity of the design or the technology. This may be carried out taking a representative example of the design documents of one or various sorts of devices under manufacturing, the subsequent examinations, especially the assessment of design changes that may impact the compliance with essential requirements being an integral part of the supervision activities carried out by the notified body.
The inconsistency of the classification rules which
resulted in the lack of the classification of the invasive devices of the body orifices intended to be connected to a active medical device of class I is eliminated, and devices intended to disinfect invasive devices are reclassified in class IIb
.
In compliance with the essential requirements for the design and manufacture of medical devices the manufacturers are under the obligation to avoid the use of substances which may compromise the patient’s health in particular carcinogenic, mutagenic substances or the ones toxic for reproduction, and, when appropriate, to aim at the development of alternative substances or products representing a lower risk potential.
It was decided to apply, as of now, to in vitro diagnosis medical devices the provisions of this decree-law regarding the surveillance, manufacture and wholesale distribution advertisement, confidentiality and supervision, taking into consideration that these rules are transversal.
The bodies of the government of Autonomous Regions were consulted.
National Data Protection Commission was consulted also.
The hearing of National Council for Consumption was promoted.
As an option National Federation of Consumers Cooperatives, General Union of Consumers and Portuguese Association for the Protection of the Consumer were consulted also.
Therefore:
According to the provisions of subparagraph a) of no. 1 of article 198 of the Constitution, the Government decrees the following:
CHAPTER I
General Provisions
Article 1
Object
This decree-law provides for the rules to be complied with by the research, manufacture, marketing, commissioning, surveillance and the advertisement of medical devices and respective accessories, hereinafter referred to as devices, converting in national law Directive no. 2007/47/CE, of the European Parliament and of the Council, of 5 September.
Article 2
Scope
1 — All medical devices and respective accessories are subject to the provisions of this decree-law, notwithstanding the provisions of the following numbers.
2 — This decree-law applies also to devices which:
a) Include as an integral part any substance which, if used separately, is considered to be a medicinal product, according to Decree-law no. 176/2006, of 30 August, and which may affect the human body by means of an action accessory to that of the device;
b) Include, as an integral part, a substance which when used separately is likely to be considered as a constituent of a medicinal product or human or plasma blood derivative medicinal product, according to Decree-law no. 176/2006, of 30 August, and which may affect the human body by means of an action accessory to that of the device, hereinafter referred to as «human blood derivative substance»;
c) Are intended to administer a medicinal product, notwithstanding the latter being under the legal system medicinal products for human use.
3 — This decree-law does not apply to:
a) The in vitro diagnosis devices, notwithstanding the provisions of articles 66 to 68;
b) To medicinal products covered by Decree-law no. 176/2006, of 30 August, and to decide if a specific product falls under the scope of that system or under the scope of this Decree-law; the main mode of action of the product should be taken into consideration;
c) to devices intended to administer a medicinal product, marketed in such a way that the device and the medicinal product become one integrated product only, intended to be used exclusively in that association and cannot be reused, to which Decree-Law no. 176/2006, of 30 Augusto applies;
d) To cosmetic and personal hygiene products;
e) To human plasma and blood, to human blood derivative products or blood cell of human origin, or devices which at the moment of being marketed contain such blood derivative products, plasma and cells, except for the devices mentioned in subparagraph b) of the previous number;
f) To organs, tissues or cells of human origin or products containing tissues or cells of human origin or which derive from them, except for the devices mentioned in subparagraph b) of the previous number;
g) To organs, tissues or cells of human origin, except if they are animal tissues which have become non-viable, or non-viable products derived from tissues originating from animals, used in the manufacture of devices.
4 — The essential requirements provided for in annex I of this decree-law, of which it is an integral part, regarding safety and performance apply to devices mentioned in subparagraph c) of the previous number.
5 — The devices intended by the manufacturer to be used in accordance with the provisions regarding individual protection equipment and of this decree-law should also comply with the requirements relevant in terms of health and safety preservation provide for in Decree-law no. 128/93, of 22 April, amended by Decree-Law no. 139/95, of 14 June, and Decree-Law no. 374/98, of 24 November, converts Directive no. 89/686/CEE, of the Council, of 21 December into national law.
6 — This decree-law is a specific statute according to no. 3 of article 2 of Decree-Law no. 325/2007, of 28 September, regarding the electromagnetic compatibility of the equipment items.
7 — This decree-law does not prejudice the application of Decree-Laws nos. 165/2002, of 17 July, and 167/2002, of 18 July, regarding the protection against ionizing radiations, nor Decree-Law no. 180/2002, of 8 August, in medical radiological exposure, which convert Directives nos. 96/29/Euratom and 97/43/Euratom, of the Council, of 13 May, and 30 June, respectively.
8 — The obligations resulting from this decree-law for the manufacturers apply also to the legal person or corporate body which assembles, packages, carries out, renews, remodels, changes the type or labels one or several prefabricated products or intended for a device aiming at its marketing under its specific name.
9 — The provisions of the previous number do not apply to non manufacturing entities which assemble or adjust to a specific patient, devices already in the market, according to the respective purpose.
Article 3
Definitions
For the purposes of this decree-law, it is understood as:
a) «Safety corrective action» is what the manufacturer does to reduce death risk or serious deterioration of health status, resulting from the use of a medical device already in the market, which can consist on the return, alteration, exchange or destruction of medical devices or rather on information on the use of medical devices which should be notified by means of a safety notice;
b) «Accessory is the item which, without being a device, is specifically intended by the manufacturer to be used with a device, so as to enable its use in compliance with the manufacturer’s instructions for the device use;
c) «Adverse event» any unfavourable clinical manifestation, regardless of any causal association with the device;
d) «Serious adverse event» the adverse event leading to death or a serious deterioration of the state of health;
e) «Serious threat to public health» any occurrence resulting in imminent risk of multiple deaths in a short period of time, serious deterioration of the state of health or serious disease, which requires an immediate action, since it involves a potential risk for public health;
f) «Competent Authority» o INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde, I. P., (National Authority of Medicinal Products and Health Products) hereinafter referred to as INFARMED, I. P.;
g) «Safety notice» the document prepared by the manufacturer in Portuguese, or one of his representatives, to provide information to users of the medical device, regarding a safety corrective action;
h) «Clinical research good practices» the set of legal requirements recognised internationally, which should be complied with for the design and carry out of the clinical researches in particular standard EN ISO 14155, and subsequent reviews;
i) «Investigator’s Brochure» the compilation of clinical and non clinical information regarding the device under research relevant for research on human beings;
j) «Research site, research place » the institution or place where the clinical research takes place;
k) «Marketing» the first time a device non intended for clinical research is made available, free of charge or not, to be distributed or used in the community market, irrespective of being a new or renovated device;
l) «Ethical commissions for health» the entities created by Decree-Law no. 97/95, of 10th May, on which the issue of an opinion provided in this law is incumbent;
m) «Informed consent» the decision expressed by means of a mandatory written, dated and signed declaration of the wish to be part of clinical trial, freely taken by someone with the capacity to give his/ her consent or, in the case such capacity is lacking
by his/her legal representative, after having been duly informed on the nature, the extent, the consequences and risks of the trial and having received suitable documents; and which includes the verbal consent, exceptionally, before two witnesses, if the declaring person is in no conditions to give his/her written consent;
n) «Clinical Data» the information regarding safety or performance, obtain4d from the use of a device, resulting from:
i) Clinical research of the concerned device; or
ii) Clinical research, or other studies included in s cientific literature, of a similar device with an equivalence with the concerned device that can be demonstrated; or
iii) Reports, whether published or not, on other clinical experiments, both with the concerned device and a similar device with an equivalence with the concerned device that can be demonstrated;
o) «Indirect damage» the damage which may occur as a consequence of a medical decision, based on information or results obtained by means of the use of a medical device, according to the manufacturer’s instructions;
p) «Performance» the behaviour shown by the device while it is been used according to the manufacturer’s instructions;
q) «Serious deterioration of the state of health» the clinical condition when there is:
i) Life-threatening disease or injury;
ii) Permanent disablement of a body structure or function;
iii) Need of admission to hospital, or extension of stay in hospital, or medical or surgical intervention to prevent life- threatening disease or injury or to prevent Permanent disablement of a body structure or function;
iv) Foetal pain of death, congenital anomaly or birth malformation;
r) «Single-use device», the device intended to be used just once with a single patient;
s) «Custom-made device» any medical device specifically manufactured according to medical prescription, under the responsibility of the prescribing physician, with the indication of specific design characteristics and which is intended, as such, to be exclusively used in a certain patient, not considering the mass produced devices manufactured according to methods of continuous manufacture or mass production which lack the adjustment to meet the specific requirements of the physician or any other professional user;
t) «Medical device » any instrument, apparatus, equipment, software, material or item used separately or in combination, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes and which is required for the good operation of the medical device, and which main intended effect in the human body is not achieved by pharmacological, immunological or metabolic means, even if its operation may be supported by those means and intended by the manufacturer to be used with human beings for the following purposes:
i) Diagnosis, prevention, control, treatment or relief of a disease;
ii) Diagnosis, control, treatment, relief or compensation of an injury or a deficiency;
iii) Study, replacement or anatomical alteration or of a physiological process;
iv) Birth Control;
u) «Active medical device» any medical device working from an electrical power source, or another one generated directly by the human body or the gravity, and which operates through the conversion of that power, not being considered as such devices intended for the transmission of power, substances or other elements between an active medical device and a patient without any significant change the software being considered as an active medical device on its own;
v) «Active implantable medical device» any active medical device designed to be totally or partially introduced by means of a surgical or medical intervention in the human body or by medical intervention on a natural orifice and intended to be implanted;
x) «Device used for in vitro diagnosis»:
i) Any medical device consisting on a reagent, reagent product, calliper, control material, set, instrument, apparatus, equipment or system used isolated or in conjunction intended by the manufacturer to be used in vitro to analyze samples from the human body, including donated blood and tissues, exclusively or mainly with the purpose to get data regarding the physiological or pathologic condition, congenital abnormalities, the establishment of safety and compatibility with potential receptors, or the control of therapeutic measures;
ii) The containers for samples, understood as such the vacuum devices or not, especially intended by the manufacturer to contain and preserve samples coming directly from the human body for the purposes of conducting an in vitro diagnosis study;
iii) The products intended for generic uses in laboratory, provided, due to their characteristics, they are specifically intended by the manufacturer for in vitro diagnosis exams;
z) «Device for clinical research » any device intended to be used by a investigator, in a research centre, aiming at being submitted to researches mentioned in no 13 of annex XVI of this decree-law, of which it is an integral part, in a suitable human clinical environment, being compared to a speciality physician, for the purpose of conducting the clinical researches, anyone who, given his/her professional qualifications, is authorized to carry out the mentioned researches;
aa) «Wholesale distribution» the activity of procurement, possession, storage or supply of medical devices intended for resale or use in medical services, health centres, pharmacies and other points of sale to the public, excluding the retail sale;
bb) «Commissioning» the stage when a device is at the disposal of the final user or, in the case of active implantable medical devices, at the disposal of the medical staff for implantation, as being ready for the first use in the community market, in compliance with the intended purpose;
cc) «Manufacturer» the legal person or corporate body in charge with the design, manufacturing, packaging and labelling of a medical device, aiming at its marketing under its own name, regardless of the mentioned operations being carried out by that person or third parties on his behalf;
dd) «Purpose» the use the device is intended for, according to the indications of the manufacturer on the labelling instructions and/or promotional material;
ee) «Generic group of devices» the group of devices with the same or similar purposes of use, or common technology, which allows to classify them in a generic way, not reflecting any specific characteristics;
ff) «Incident» any adverse or undesirable occurrence likely to cause the death, deterioration of health status, or even risk for the patient and the user’s health or public health, or even another occurrence the experience shows the need to be notified where there is a suspicion of a causal connection between the occurrence and the use of the medical device;
gg) «Clinical research» any systematic study in human beings planned and designed with the purpose to check for the safety and/or the performance of a specific device;
hh) «Investigator» a physician or another person with a profession recognized in Portugal for the practice of a research activity due to scientific qualifications and experience with providing health care to patients required by that activity, who is responsible for clinical research at the research centre;
ii) «Representative» the legal person or the corporate body, established on the European Union, who, or which, having been expressly appointed by the manufacturer, acts and may be interpellated by authorities of the European Union on behalf of the manufacturer as to what concerns the latter’s obligations, according to the provisions of of this Decree-law;
xx) «Notified body» the body appointed to assess and check the compliance of the devices with the requirements provided for in this decree-law, as well as to approve, issue and keep the compliance certificates;
ll) «Participant» the person who participates in a clinical research both as receiver of the device under research and control purposes;
mm) «Clinical research Plan» the document describing the justification, objectives, design, methodology, monitoring, statistical aspects,
the organization and conducting of a research, as well as keeping the respective records in archive;
nn) «trend report» the sort of report to be used by the manufacturer, when there is a significant increase of adverse events, which are not normally considered as incidents, and for which pre-defined levels of action requiring the need for notification were established;
oo) «Final report of clinical research» the description,
the results and the assessment of the clinical research, after its conclusion;
pp) «Periodic short report» the sort of report, previously agreed between the manufacturer and the competent authority, used to notify incidents with the same device, in a consolidated, when the cause for the incident is clearly known or the suitable corrective action has already been implemented;
qq) «Devices subcategory » the set of devices with foreseen common areas of use or common technology.
Article 4
Classification
1 — The devices are integrated in classes I, IIa, IIb e III, taking into account the vulnerability of the human body and the potential risks resulting from the technical design and the manufacturing, this classification being made according to the provisions of annex IX of this decree-law, of which it is an integral part.
2 — In case of a conflict between a manufacturer and a national notified body as to the application of the classification rules, the issue is submitted to the decision of the competent authority.
3 — The classification rules included in annex IX
of this decree-law, which is an integral part of it, should be adjusted according to the technical progress or the information available in the meantime, by means of the surveillance system of the medical devices provided for in articles 27 and 28.
4 — This article does not apply to active implantable medical devices.
CHAPTER II
Requirements for marketing and presumption of
conformity
Article 5
Requirements for marketing
1 — Devices can only be marketed and be commissioned if cumulatively:
a) They comply with the essential requirements provided for in annex I of this decree-law of which it is an integral part, or, in the case of active implantable medical devices, in annex X of this decree-law, of which it is also an integral part when duly delivered and installed, kept and used according to the respective purpose;
b) They show EC marking, according to the provisions of article 7;
c) They have been the object of a conformity assessment, according to the provisions of article 8.
2 — Whenever there is a relevant risk, the devices which are also machines according to the provisions of subparagraph a) of article 2 of Directive 2006/42/CE of the European Parliament and the Council, of 17 May, regarding machines, should comply also with the essential requirements in terms of health and safety are more specific than the essential requirements mentioned in annex I of this decree-law, of which it is an integral part, or, in the case of active implantable medical devices, in annex X of this decree-law, of which it is also an integral part.
3 — The devices intended for clinical research may be made available to the investigators, provided they meet the conditions established in this decree-law.
4 — The custom-made devices may be marketed and commissioned provided they comply with the provisions of article 8 and annex VIII of this decree-law of which it is an integral part, or in the case of active implantable medical devices, in conjunction with the provisions of annex XV of this decree-law, of which it is also an integral part, the devices of classes IIa, IIb and III and active implantable medical devices should be accompanied with a declaration mentioned in those annexes, which is provided to the concerned patient, identified by name or, acronym or number code if the latter shows such an intention.
5 — In the scope of industrial fairs, exhibitions and other demonstrations, the presentation of the devices is authorized, even if they do not comply with the requirements included in this decree-law, provided their non-conformity, is duly pointed out, as well as the impossibility of being marketed or commissioned before they are in conformity.
6 — The labelling and use instructions of any devices should be in the Portuguese language and comply with the provisions of no. 13 of annex I of this decree-law, of which it is an integral part, or, in the case of active implantable medical devices of nos. 17, 18 and 19 of annex X of this decree-law, of which it is an integral part, whether or not they are intended for a professional use.
7 — Notwithstanding the provisions o no 6, the labelling and use instructions may also be worded in other languages.
Article 6
Presumption of conformity
1 — Devices complying with the harmonized rules the references of which have been published in the Official Journal of the European Union are presumed to be in compliance with the essential requirements provided for in annex I of this decree-law, of which it is an integral part, or, in the case of active implantable medical devices, in annex X of this decree-law, of which it is also an integral part.
2 — For the purposes of the provisions of the previous number, it is understood that the reference to harmonized rules covers also the monographs of European Pharmacopea, namely as to surgical suture e the interaction of interaction between medicinal products and the materials containing them whose references have been published in Official Journal of the European Union.
CHAPTER III
EC marking and conformity assessment procedures
Article 7
EC marking
1 — The devices, except for the custom-made and those intended for clinical researches, which are compliant with the essential requirements mentioned in article 5 should show EC marking, which complies with the requirements provided for in annex XVII of this decree-law, of which it is an integral part.
2 — EC marking should be affixed by the manufacturer in a visible, legible and indelible way on the device or the package which ensures the sterilization, if practicable and suitable, as well as in the instructions of use and the trade package .
3 — In the case of active implantable medical devices , the EC marking should be affixed by the manufacturer in a visible, legible and indelible way on the package which ensures the sterilization, and if practicable and suitable on the trade package, as well as in the instructions of use.
4 — The EC marking should be accompanied by the identification number ascribed to the body in charge with the conformity assessment procedures.
5 — Whenever the procedures are the object of other regulations regarding other aspects that also require the a affixing of EC marking, this should state that the devices correspond also to the provisions of those other regulations.
6 — If one or more of the regulations provided for in the previous number allows the manufacturer, during a transitory period, to chose the measures he wants to take, the EC marking should state that the devices correspond only to the provisions of the regulations implemented by the manufacturer, in which case the references of the implemented regulations, as they are published on the Official Journal of the European Union, should be stated in the documents, manuals or instructions required by the regulations accompanying the mentioned devices.
7 — The manuals or instructions mentioned in nos. 2 and 3 must be accessible without having to violate the package that ensures the sterility of the device.
8 — The affixing of markings or inscriptions likely to be confused with the EC marking is prohibited, notwithstanding the possibility of affixing any other marking on the device, the package or the instructions leaflet accompanying the device, provided that affixing does not reduce the visibility or legibility of the EC marking.
9 — Notwithstanding the provisions of article 29, when it is detected that, violating this decree-law, the EC marking was unduly affixed or does not exist, the manufacturer, or its representative, should endeavour to stop immediately this infringement according to the conditions established by the competent authority.
10 — If the non-conformity persists, the competent authority should take the necessary measures to prohibit the marketing of the device or to ensure its recall, according to the similar provisions of article 29.
11 — The competent authority notifies the manufacturer or its legal representative on the detected irregularities.
12 — The provisions of nos. 9 and 10 apply also to the cases when the EC marking affixing has been improperly carried out, even if in compliance with the procedures provided for in this decree-law, but for products not covered by it.
Article 8
Conformity assessment procedures
1 — Except in cases provided for in nos. 3 and 4 of article 5, the manufacturer of the device may, regarding the EC marking:
a) As to class III devices chose one of the following procedures:
i) Procedure regarding the EC declaration of conformity mentioned in annex II of this decree-law, of which it is an integral part;
ii) Procedure regarding the type of CE examination mentioned in annex III of this decree-law, of which it is an integral part, together with the EC verification procedure provided for in annex IV of this decree-law, of which it is an integral part, or together with the guarantee procedure of manufacturing quality provided for in annex V of this decree-law of which it is an integral part;
b) Regarding the class IIb devices it may chose one of the following procedures:
i) Procedure regarding EC declaration of conformity provided for in annex II of this decree-law, of which it is an integral part, except for its no. 5;
ii) Procedure regarding the type of CE examination mentioned in annex III of this decree-law, together with procedure provided for in annex IV of this decree-law, of which it is an integral part, together with procedure provided for in annex V of this decree-law, of which it is an integral part, or together with the guarantee procedure of product’s provided for in annex VI of this decree-law, ofwhich itisanintegralpart;
c) As for class II a devices:
i) Procedure regarding the CE declaration of conformity mentioned in annex VII of this decree-law, of which it is an integral part, together with procedure provided for in annex IV of this decree- law, of which it is an integral part, or together with procedure provided for in annex V of this decree-law, of which it is an integral part, or together with procedure provided for in annex VI of this decree-law, of which it is an integral part; or
ii) Procedure regarding EC declaration of conformity provided for in annex II of this decree-law, of which it is an integral part, except for its no. 5;
d) In the case of class I devices the manufacturer should adopt the procedure mentioned in annex VII of this decree-law, of which it is an integral part, and prepare, before the respective marketing, the due EC declaration of conformity.
2 — Except for the cases provided in nos. 3 and 4 of article 5, the manufacturer of active implantable medical devices should, aiming at the EC marking, chose one of these procedures:
a) Procedure regarding the EC declaration of conformity mentioned in annex XI of this decree-law, of which it is an integral;
b) Procedure regarding the type of CE examination mentioned in annex XII of this decree-law, of which it is an integral part, together with both the procedure provided for in annex XIII of this decree-law, of which it is an integral part, and procedure provided for in annex XIV of this decree-law, of which it is an integral part.
3 — In the case of custom-made devices, the manufacturer should apply the provisions of annex VIII of this decree-law, of which it is an integral part, or in the case of active implantable medical devices, in annex XV of this decree-law, of which it is an integral part, and
prepare the declaration mentioned in those annexes, and forward to the competent authority the list of the devices of this sort marketed by the former.
4 — In the conformity assessment procedure of a device, the manufacture and if, that is the case, the notified body should consider the results of the assessment and verification operations carried out at a manufacturing intermediate stage, in compliance with the provisions of this decree-law.
5 — The manufacturer may have its representative implementing the procedures provided for in annexes III, IV, VII and VIII of this decree-law, of which they are an integral part, or, in the case of active implantable medical devices, in annexes XII, XIII and XV of which they are an integral part.
6 — The manufacturer should keep the declaration of conformity, technical documentation mentioned in annexes II a to VIII, of this decree-law, of which they are an integral part, decisions, reports and certificates prepared by the notified body and make them available to the competent authority for inspection purposes for a period of five years after the last product has been manufactured.
7 — In case of implantable medical devices, the manufacturer should keep the declaration of conformity and technical documentation mentioned in annexes II to VI, VIII and XI to XV of this decree-law, of which they are an integral part, decisions, reports and certificates prepared by the notified body and make them available to the competent authority for inspection purposes for a period of 15 years after the last product has been manufactured.
8 — If the manufacturer is not established at a Member State of the European Union, the obligation to make documentation mentioned in the previous number available applies to its respective representative.
9 — If the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or its representative may address a body of its choice based on
any Member State chosen for that purpose.
10 — The processes and correspondence mentioned in the previous numbers, when occurring in Portugal, must be written in Portuguese, unless the notified body accepts another community language.
11 — The notified body, may request any information or data necessary to issue and keep the certificate of conformity, taking into account the adopted procedure.
12 — The decisions of the notified body in compliance with annexes II, III, V and VI of this decree-law of which they are an integral part, or, in the case of active implantable medical devices with annexes XI, XII, and XV of this decree-law, of which they are an integral part are valid for a maximum of five years and are extendable for periods not longer than five years, by means of an application submitted within the timeframe established in the contract signed between the notified body and the manufacturer.
13 — The manufacturer should keep the documentation regarding the procedures to assess the conformity of the devices at the disposal of the notified body.
14 — The refusal or omission of data regarding the assessment mentioned in the previous number is considered as a non compliance with the essential requirements.
15 — The competent authority may, upon duly justified application, and whenever such use contributes for the health protection
authorize the marketing and commissioning of specific devices, which haven’t yet been the object of legally required assessment procedures of conformity.
Article 9
Sterilization procedure
1 — Any legal person or corporate body which sterilizes medical devices with C marking designed by their manufacturer to be sterilized before being used, aiming at its marketing should chose one of the procedures provided for in annexes II or V of this decree-law, of which they are an integral part, and prepare a declaration stating sterilization was carried out according with the manufacturer’s instructions.
2 — The application of the procedures and the intervention of the notified body mentioned in the previous number shall be limited to the parts of the process regarding the sterilization and its maintenance until the sterilized package is open or violated.
3 — The devices mentioned in no. 1 do not show an additional EC marking, and should be accompanied with the information provided for in no. 13 of annex I of this decree-law, of which it is an integral part, including also the one provided by the manufacturer of the device.
4 — The declaration mentioned in no. 1 should be made available to the competent authority for a period of 5 years counting from its issuing.
5 — The provisions of this article does not apply to active implantable medical devices.
Article 10
Special procedure for systems and sets for interventions
1 — Any legal person or corporate body which assemble systems and sets of devices with EC marking, in compliance with the respective purpose and the restrictions of use provided for by their manufacturers aiming at their marketing as systems or sets for interventions, should prepare a declaration comprising:
a) The confirmation of reciprocal compatibility of the devices in compliance with the manufacturers’ instructions, as well as the respective assembly;
b) That the package of the system or set was carried out in compliance with the essential requirements, namely regarding information to the users, according to no. 13 of annex I of this decree-law, of which it is an integral part, including pertinent instructions of the devices included in the system or set;
c) The suitable control, as well as the necessary inspections for all carried out operations.
2 — Whenever the conditions mentioned in the previous number are not complied with, namely in the cases when the system or the set incorporate devices with no EC marking or when the combination is not compatible, taking into account the initial purpose of these devices, the system or set for interventions is considered a device itself and is, therefore, subject to the provisions of article 8.
3 — The devices mentioned in no. 1 do not show an additional EC marking and should be accompanied with the information provided for in no. 13 of annex I of this decree-law, of which it is an integral part, including also the one provided by the manufacturer.
4 — The declaration mentioned in no. 1 should be kept at the disposal of the competent authority for a period of five years counting from the date it is issued.
5 — The provisions of the previous article apply to sets for intervention which should be sterilized before being used.
6 — The provisions of this article do not apply to active implantable medical devices.
CHAPTER IV
Marketing
Article 11
Duties inherent to marketing
1 — Any manufacturer with address or registered office in Portugal marketing devices belonging to class I or custom-made devices on his own behalf should notify the competent authority on the following details:
a) Name or corporate name and address or head-office;
b) All data required for the full identification of the concerned device.
2 — The provisions of no. 1 apply also to any legal person or corporate body with address or head-office in Portugal practicing in its own name the activities mentioned in articles 9 and 10.
3 — The commissioning in national territory of each medical device belonging to classes IIa, IIb and III or active implantable medical devices is notified by its manufacture or the competent representative to the competent authority by means of a declaration containing the following details:
a) Name or firm and residence or full address and head-office of the manufacturer and representative and wholesale dealers in the national territory;
b) Trade names of the device in Portugal and in all countries of the European Union;
c) Type of device and model;
d) Description of its purpose;
e) Identification number of the notified body intervening in the conformity assessment procedure;
f) Labelling and instructions of use, including the calibration instructions and the maintenance manual;
g) Marketing or commissioning date in national territory;
h) Any certificates or significant changes included, namely the marketing suspension.
4 — In case the devices are marketed by the manufacturer on its own behalf and he does not have an address or registered office in a Member State of the European Union the former should appoint a sole representative in the European Union for each device, which shall be subject to the compliance with the obligations mentioned in the previous numbers and in the case devices belonging to class I or custom-made
devices, the representative should notify the competent authority of the member state where it has its registered office the data mentioned in no. 1.
5 — The changes of details of mandatory notification according to the provisions of the previous numbers should also be notified to the competent authorities.
6 — Data mentioned in no. 1, notified by the manufacturer or the representative, as well as its changes should be notified by the competent authority to the European Commission and to the other member States upon request.
CHAPTER V
Clinical research
Article 12
Procedure
1 — The manufacturer of devices for clinical research, or its representative, should apply the procedure mentioned in annex VIII of this decree-law, of which it is an integral part, or, in the case of active implantable medical devices, in annex XV of this decree-law, of which it is an integral part, and notify the competent authority by means of a declaration mentioned in no.
2.2 of annex VIII of this decree-law, of which it is an integral part, or, in the case of active implantable medical devices, in no 2.2 of annex XV of this decree- law, of which it is an integral part, if the research takes place in national territory.
2 — The manufacturer may start the clinical research 60 days after the notification to the competent authority, regarding the devices of class III, as well as the active implantable and invasive devices of classes IIa or IIb to be used for long periods.
3 — The provisions of the previous number do not apply if the competent authority issues a decision otherwise, grounded on health or public health reasons and notified to the manufacturer within the same timeframe.
4 — The research depends on the decision of the competent authority in which, after the assessment of risks and benefits it is concluded that the potential individual benefits for the participant in the trial and other current or future participants exceed the possible predictable and inconvenient risks.
5 — During the research, the compliance with the conditions provided for in the previous number must be the object of permanent monitoring.
6 — The timeframe provided for in no. 2 may be reduced in the case there is a favourable opinion of the respective health ethical committee regarding the concerned research program, which includes its critical appraisal of the clinical research plan, and after the competent authority’s authorization.
7 — The provisions of nos. 1 and 2 do not apply to devices showing a EC marking, except in cases when the purpose is different from the one foreseen in the conformity assessment procedure.
8 — The exception provided for in the previous number does not apply to active implantable medical devices.
9 — The provisions of no. 7 does not prejudice the application of the pertinent provisions of annex XVI of this decree-law of which it is an integral part.
10 — For the devices of classes not mentioned in no. 2, the beginning of the clinical research depends only on the assenting opinion of the competent ethics committee on the concerned research program, including the critical assessment of the clinical research plan and also the notification to the competent authority.
11 — The clinical research must be carried out in compliance with annex XVI of this decree-law, of which it is an integral part.
12 — The manufacturer and its representative should keep the report mentioned in no. 25 of annex XVI of this decree-law, of which it is an integral part at the disposal of the competent authority.
13 — The ethical principles of the legal system of clinical researches for medicinal product for human use with the adjustments of this chapter apply to the clinical researches of devices.
Article 13
Health ethics committee
1 — The health ethics committee working in the research centre is qualified to issue the opinion provided for in this decree-law.
2 — The competent health ethics committee when issuing an opinion on the execution of the research is subject to the following duties:
a) To assess, in an independent way, the methodological, ethical and legal aspects of the researches submitted to it;
b) To monitor the researches, especially as to the ethical aspects and the safety and integrity of the participants;
c) To provide all information and clarifications on requests submitted to it;
d) To ensure the participation of independent experts in the assessment of the requests submitted to it, whenever that is necessary;
e) To ensure the follow up of the research from its beginning to the presentation of the final report.
Article 14
Opinion
1 — The opinion of the health ethics committee is issued upon request submitted by the manufacturer as the promoter of the concerned clinical research.
2 — The details that should be included and accompany the request mentioned in the previous number are established by regulation of the competent authority, to be issued within 90 days.
3 — In its opinion the competent ethics committee should pronounce itself on:
a) The relevance of the research and its conception;
b) If the result of the assessment of the predictable benefits and risks is favourable;
c)The plan;
d) The suitability of the research team;
e) The investigator’s brochure;
f) The quality of the facilities;
g) The suitability and the comprehensive nature of the written information to provide, as well as the procedure to obtain the free and informed consent;
h) The reasons to carry out the research on people unable to give their free and informed consent, according to the provisions of nos. 16 and 17 of annex XVI of this decree-law, of which it is an integral part;
i) The provisions on the compensation for
damages relating to property or moral ones including the death damage, ascribable to the research;
j) All insurances intended to cover the investigator and the manufacturer’s responsibility as promoters;
l) The amounts and the retribution or possible compensation methods of the investigators and participants in the clinical researches and the pertinent details of any other financial contract provided for between the manufacturer as promoter and the research centre;
m) The recruitment methods of the participants.
Article 15
Refusal or interruption of the clinical research
1 — If the competent authority refuses or interrupts a clinical research, it should notify the authorities of all member States and the European Commission on its decision.
2 — If the competent authority requests a significant change or temporary interruption of a clinical research, it should notify the authorities of all member States involved in the clinical research on the measures it approved and the respective justification.
Article 16
Completion of clinical research
1 — The manufacture or its representative should notify the competent authority about the completion of the clinical research, the notification including the due justification in case of bringing forward the termination.
2 — In the case of bringing forward a clinical research termination for safety reasons, the notification is conveyed by the competent authority to the authorities of all member States and the European Commission.
Article 17
Safety urgent measures
1 — The manufacturer and the investigator take all urgent measures deemed to be suitable to the protection of the participants against any immediate risk regarding their safety, namely the one resulting from the supervenience of any fact related to the progress of the clinical research or the development of the device under research.
2 — The manufacturer conveys with no delays to the competent authority, the other competent authorities of the member States involved and the health ethics committee the risks and the adopted measures.
Article 18
Remuneration
1 — The remuneration of the investigator and, as the case may be, the members of his team is permitted.
2 — For the purposes of the previous number, team members are considered all of those integrating the research team as well as the professionals who due to their tasks have a direct and immediate participation in the research.
3 — Whenever the investigator or the members of his team are civil servants of National Health Service, the remuneration provided for in the financial contract is paid by the research centre, in compliance with the general rules on plural duties provided for in Law no. 12-A/2008, of 27 February.
Article 19
Financial Contract
1 — The manufacturer or its representative should sign the financial contract with the research centre.
2 — The following details should be included in the financial contract:
a) The conditions of the research;
b) The conditions of its coming into effect;
c) The economic aspects related with the contract such as:
i) The direct costs of the research established by the research centre, detailing, individually, the remuneration of the investigator and the other team members;
ii) The indirect costs, as those incurred with the use of auxiliary diagnostic means, those resulting from not foreseen participant’s hospitalization, the ones resulting from reimbursement and indemnity or compensation for the expenses and damages suffered by the participant;
iii) Time limits for payment;
d) All other conditions established between the parties.
Article 20
Devices and medicinal products used for the research
1 — The devices under research and other used jointly in the research, as well as the medicinal products required for the research are provided by the manufacturer free of charge.
2 — After the research is concluded, the device under research should, until it is marketed, be made available for free by the manufacturer to the participant, in case the investigator deems indispensable the participant to continue using it and there are no therapeutic alternatives.
3 — For the purposes of the provisions of the previous number the investigator should:
a) Get the free and informed consent of the participant or his/her legal representative;
b) To submit clinical explanatory report about the need to continue the treatment;
c) To notify the competent authority, as soon as possible, the device is still being used;
d) To notify the person in charge with the health unit the device is still being used;
e) To notify the competent authority of the adverse events occurring during the use of the device.
Article 21
Supervision
1 — To check the compliance with the provisions of this chapter and those regarding good practices for clinical research, the competent authority may supervise:
a) The specific locations where the clinical research takes place;
b) The specific location for manufacturing the device under research;
c) The analysis laboratories used for the clinical research;
d) The manufacturer’s facilities;
e) Another undertaking related to the clinical research which is considered to need supervision.
.
2 — The competent authority may also:
a) To carry out at the manufacturer’s facilities, the research site or the contracted research body, the collection and seizure of the documents and records regarding the clinical research and the quality guarantee systems whenever that such endeavour is deemed to be necessary for the taking of evidence;
b) To seal the manufacturer’ s facilities or the research body where documents and other details required for taking of evidence can be found or are likely to be found, during the period of time and to the extent strictly required to carry out the endeavours mentioned in the previous subparagraph.
3 — After the supervision mentioned in the previous numbers the competent authority prepares a report on the supervision.
4 — The report mentioned in the previous number is made available to the supervised entity, except for confidential information.
5 — Upon justified request, the competent authority may also make the supervision report available to the competent authorities of other member States or the European Commission or the competent ethics committee.
CHAPTER VI
Notified body
Article 22
Appointment, supervision and duties
1 —INFARMED, I. P., appoints the national bodies that carry out the procedures provided for in article 8 and allocates the specific tasks of each body, notifying the European Commission and the other State members the European Union of those acts.
2 — The appointment of the notified bodies is compliant with the criteria mentioned in annex XVII of this decree- law of which it is an integral part.
3 — The criteria mentioned in annex XVII of this decree-law, of which it is an integral part, are presumed to be complied with by the notified bodies accredited by Instituto Português de Acreditação, I. P. (IPAC, I. P.) (Portuguese Institute of Accreditation),
complying with the national standards converting applicable harmonised standards or the notified bodies in compliance with the criteria provided for the standards published by the European Commission regarding the appointment and the monitoring of the activity of those bodies.
4 — The competent authority should carry out an ongoing supervision on the notified bodies so as to guarantee the compliance included in the criteria provided for in annex XVII of this decree- law, of which it is an integral part.
5 — If the competent authority becomes aware that a notified body has failed to comply with the criteria mentioned in annex XVII of this decree-law, of which it is an integral part, it should cancel or restrict the notification, notifying at once the European Commission and the member States of the fact.
6 — The appointment of the notified bodies, as well as the identification number ascribed to them by the Commission, are published in the 2 nd series of the Official Gazette.
7 — The notified body and the manufacturer or the representative establish, upon mutual agreement, the deadlines for the conclusion of the assessment and supervision operations mentioned in annexes II to VI of this decree-law, of which they are an integral part, or, in the case of active implantable medical devices, in annexes XI to XIV of this decree-law, of which they are an integral part also.
8 — Performing its duties, the notified body takes into account all pertinent information regarding the characteristics and the functional behaviour of the devices, including, namely, the results of the trials and pertinent checks already carried out according to the law.
9 — The notified body should notify:
a) The respective competent authority of all issued, modified, completed, suspended removed or refused certificates and upon request all additional relevant information;
b) The other notified bodies covered by this decree-law of the suspended, removed or refused certificates, and upon request of the issued certificates.
10 — The notified body should, according to the proportionality principle, suspend, remove or impose some restriction on the issued certificate, if it becomes aware that a manufacturer is not complying or failed to comply with the requirements provided for in this decree-law or that the certificate should not have been issued, unless the manufacturer guarantees the compliance with those requirements by means of suitable.
11 — In the cases mentioned in the previous number, and whenever the intervention of the competent authority is required, the notified body notifies the latter, which, in turn, should notify the European Commission and the member States.
12 — Upon request, the notified body provides, , all information and documents, including the budget documents, required to allow the competent authority to check for the compliance with the requirements mentioned in annex XVII of this decree-law, of which it is an integral part.
CHAPTER VII
Use of animal tissues
Article 23
Devices manufactured using animal tissues
1 — For the purposes of the provisions of this chapter it is understood by:
a) «Cells» the smallest organized unit of any life form, capable of having an independent existence and to replace its own substance in a favourable environment;
b) «Tissue» a cell organization or extracellular constituents;
c) «Derivative» the material obtained from animal tissue by means of a manufacturing process, as the collagen, a gelatine or monoclonal antibodies;
d) «Non-viable» incapable of metabolism or multiplication;
e) «Transmissible agents» non-classified pathogenic entities, prions or other entities, as bovine spongiform encephalopathy agents (BSE) and scrapie;
f) «Reduction, elimination or removal» the process through which the number of transmissible agents is reduced, eliminated or removed, so as to prevent infectious or pathogenic reactions;
g) «Inactivation» the process through which the capability of causing infections or pathogenic reactions by transmissible agents is reduced;
h) «Country of origin» the country where the animal was born, has grown or was slaughtered;
i) «Starting products» raw materials or any other product of animal origin from which or with the help of which, the devices mentioned in the following number are manufactured.
2 — Medical devices manufactured using animal tissues that have become non viable or non viable products resulting from animal tissues, so as to minimize transmission risks, under normal conditions of use, to patients or other people, of transmissible bovine spongiform encephalopathy
(BSE), are in compliance with specific provisions included in this chapter.
3 — Animal tissues included by this chapter are those originating on bovine, ovine and goat animals, as well as stags, elks, minks or cats.
4 — Collagen, gelatine and tallow used in the manufacture of medical devices comply, at least, with the requirements necessary to be considered appropriate for human consumption.
5 — This chapter does not apply to devices mentioned in no. 2 which are not intended to come in touch with the human body or which are intended to come in touch only with intact skin.
Article 24
Risk analysis and management program
Before submitting the request of conformity assessment, according to the provisions of subparagraph a) of no. 1 of article 8, the manufacturer o of the devices mentioned
in no. 2 of article 23 should apply the risk analysis and management program provided for in annex XIX of this decree-law, of which it is an integral part.
Article 25
Updated knowledge
1 — The national notified bodies should have updated knowledge of the devices mentioned in no. 2 of article 23.
2 — It is incumbent on INFARMED, I. P., to check the compliance with the provisions of the previous number.
3 — If, after the mentioned check, INFARMED, I. P., decides to change the activity scope of the notified bodies, it should notify the European Commission and the competent appointment authorities of the other member States of that fact.
Article 26
Conformity Assessment
1 — The conformity assessment procedures of the medical devices mentioned in no 2 of article 23 cover their conformity assessment with essential requirements imposed by the this decree-law, as well as the specifications included in annex XIX of this decree-law of which it is a integral part, or other applicable legislation.
2 — The notified bodies assess the manufacturer’s risk analysis and management strategy and, especially:
a) The information provided by the manufacturer;
b) The justification to use tissues or derivatives of animal origin;
c) The results of elimination or inactivation, or bibliographical research;
d) The control system and the control by the manufacturer of the sources of raw materials, the finished products and the subcontractors;
e) The need to check aspects related to procurement, including third parties supplies.
3 — During the assessment of risk analysis and management, in the conformity assessment procedure framework, the notified bodies should take into account the conformity certificate regarding BSE issued by European Directorate for the Quality of Medicines and HealthCare for starting products whenever it exists.
4 — Except in the cases of medical devices using starting products for which a BES certificate has been issued, the notified bodies request, by means of, the respective competent authority, the opinion and the conclusions of the competent national authorities of the other member States on the assessment carried out by the latter, regarding the risk analysis and management, the tissues or derivatives, which according to the manufacturer, are intended to be incorporated in the medical device.
5 — Before issuing the design examination certificate or the EC- type examination certificate, the notified bodies should assess any remarks received within 12 weeks counting from the date when the opinion of the national authorities has been requested.
CHAPTER VIII
Surveillance
Article 27
Reporting to Competent Authority
1 — The manufacturers, representatives, dealers, health professionals and other users related to the use of medical devices should notify the competent authority on all information regarding incidents occurred in Portugal, after the devices covered by this decree-law have been marketed, such as:
a) Any dysfunction, breakdown or deterioration of the characteristics or the performance, as well as any imprecision, omission or insufficiency in labelling or the instructions for use of a device, which are likely to cause or to have caused the death or a serious deterioration of a patient, user or third party’s health status;
b) Any indirect damage, following an incorrect medical decision, regarding a medical device, when the latter is used according to the manufacturer’s instructions;
c) Any technical or medical reason regarding the characteristics or the performance of a device which, for the reasons mentioned in the previous subparagraphs, has led to a safety corrective action in the Portuguese market of devices of the same type taken by the manufacturer;
d) Other information that experience shows should be notified.
2 — Whenever the competent authority considers the information provided under the provisions of the previous number is justified, it should start the suitable procedures regarding health safeguard, namely according to article 29, notifying also the manufacturer or t, he representative.
3 — After carrying out an assessment, with the manufacturer or the its representative, if possible, the competent authority should, notwithstanding the provisions of article 29, notify, immediately the European Commission and the other Member States on the measures to adopt to minimize the recurrence of the incidents mentioned in no. 1.
4 — Reporting to the Commission and the other member States provided for in the previous number includes reporting the underlying incidents.
Article 28
National Surveillance System of Medical devices
1 — National Surveillance System of Medical devices is established, and hereinafter referred to as System, with the mission of carrying out the surveillance of incidents resulting from the use of medical devices.
2 — The System comprises an articulated set of rules and material and human means, with the purpose of collecting systematically information regarding the safety in the use in human beings of medical devices and their scientific assessment, aiming, whenever justified, at the adoption of the suitable measures for the protection of the citizens health.
3 — The purposes of the System are:
a) To minimize the risks resulting from the use of medical devices, by means of an organized system for the detection of incidents related to the devices themselves, the conditions they are provided to the user, their handling and use or the conjugation of these causes;
b) To ensure the implementation of the preventive or corrective measures necessary and suitable to solve and prevent incidents whenever the patients, users or third parties ‘safety is at stake, or an adverse event may happen again due to the same causes;
c) To make health professionals aware and motivated about the need to report incidents resulting from the use of the medical devices;
d) To supervise the actions of manufacturers, their representatives and the dealers of medical devices;
e) To collect and analyze in a critical way the information regarding accumulated experience on medical devices of the same category;
f) To enable information sharing, in the scope of safety, among the competent authority and competent authorities of other Member states, notified bodies, manufacturers, representatives, dealers of medical devices, health professionals and other users.
4 — The competent authority is the entity in charge of the follow up, coordination and implementation of the System, according to the provisions of this decree-law and its internal regulations.
5 — The powers of the competent authority, the manufacturers, representatives, dealers, health professionals and other professional users of the medical devices as well as other parties concerned with the safety of the medical devices and the structure of the system are included in annex XX of this decree-law of which it is an integral part.
6 — The competent authority prepares and disseminates the standards, technical assistance and instruments necessary to the surveillance activity of ensuring the integration of the guidelines on this subject issued by the various relevant international institutions, notwithstanding the adjustment to national specificities.
7 — According to the evolution of the system, the pharmacovigillance units as well as pharmacovigillance delegates may integrate the former, as provided for in no. 4 of annex II of Decree-Law no. 176/2006, of 30 August, as well as pharmacovigillance delegates provided for in no. 5 of the same annex.
CHAPTER IX
Safeguard
Article 29
Safeguard clause
1 — Whenever it is reported that the devices mentioned in nos. 1, 2 and 4 of article 5, even when correctly marketed, assisted and used according to the purpose they are intended for, may prejudice the health and safety of the patient or third parties, the competent authority orders its removal from the market and operation, notifying the European Commission, the manufacturer and or its representative about its justified decision, immediately.
2 — For the purposes of the previous number, itisunderstood as compromising the health and safety of the patient or third parties, the devices which do not conform with this decree- law, namely:
a) They do not comply with the essential requirements mentioned in article 5;
b) They do not comply with the standards and monographs mentioned in nos. 1 and 2 of article 6, when indicated or applied by the manufacturer;
c) They are based on standards with omissions.
3 — The decision to remove the device from the market is legally challengeable, according to the law.
CHAPTER X
Manufacture
Article 30
Notification
1 — The activities of manufacture, assembling, packaging, execution, renewal, renovation, type change, labelling or sterilization of medical devices whether intended to be marketed or to be exported is subject to the notification of the competent authority and the supervision by the latter under the provisions of this decree-law.
2 — The notification is carried out at least 60 days in advance regarding the beginning of any of the activities mentioned in the previous number.
3 — The details that should be included and accompany the notification are established by the competent authority, and should be issued within 90 days.
Article 31
Requirements
1 — The activities mentioned in no. 1 of the previous article is only allowed in case the concerned party is provided with:
a) A supervisor in charge of the quality of the performed activities;
b) Suitable facilities and equipment and with suitable capacity to ensure the manufacture, storage and preservation of the medical devices, so as to comply with their performance and security requirements.
2 — The supervisor should have a suitable technical qualification for the management and quality guarantee of the concerned activity, as well as a suitable knowledge of the legislation and other regulations applicable to the concerned medical devices.
3 — The minimum requirements regarding the manufacture of the medical devices are established in a decree-order of the member of the Government in charge with the health department, to be issued within one year.
4 — Until the decree-order mentioned in the previous number is adopted European Standard EN ISO 13485:2003 applies.
Article 32
Preparatory Enquiries
The competent authority should check if the notification is submitted on a regular basis, requesting the concerned party, if that is the case, the provision of the additional details and clarifications deemed necessary, otherwise the notification shall be declared void.
Article 33
Inspection
1 — For the purposes of the provisions of subparagraph b) of no. 1 of article 31, the competent authority, after checking the notification has been submitted on a regular basis, may decide on the need for an inspection of the facilities where the applicant intends to perform its activity.
2 — The inspection is intended to check the conformity of the facilities with the performance conditions required by this decree-law and other applicable regulations.
3 — In case the facilities are not compliant with the conditions required according to the provisions of the previous number, the concerned party is granted a timeframe not less than 30 days to correct the reported deficiencies.
4 — In case the inspection does not take place within 60 days counting from the date the notification is received, the notifying party may start its activity, being subject to a subsequent inspection and the decision on that inspection.
5 — The timeframe mentioned in the previous number is deferred whenever the applicant is required to provide additional details or clarifications or carry out the correction of defects.
Article 34
Suspension and imposition of special conditions or obligations
1 — When during the performance of the activities mentioned in no. 1 of article 30 it is reported that the requirements provided for in this Decree-law and other applicable legislation, or the conditions of the respective notification, the competent authority should order the suspension of the performance of the mentioned activities or impose special conditions or obligations.
2 — The decision mentioned in the previous number should include the respective grounds.
3 — The decision of suspension or the imposition of special conditions or obligations is legally challengeable, according to the law.
Article 35
Manufacturer’s obligations
1 — Notwithstanding the other obligations provided for in this decree-law, the individual performing the activities mentioned in no. 1 of article 30 should:
a) Comply with the minimum requirements regarding the manufacturing of the medical devices;
b) Keep the records of all transactions of medical devices carried out under the provisions of this decree-law for a period five years;
c) To provide the access of the supervision officers to the places, facilities and equipment mentioned in subparagraph
b) of no. 1 of article 31, as well as the documents and records which enable to check the compliance with the provisions of subparagraphs a) and b) of this number.
2 — The records mentioned in subparagraph b) of the previous number should include, at least, the following details:
a) Date of transaction;
b) Name of the product and other identification;
c) Supplied quantity;
d) Corporate name or name and identification of registered office or the recipient’s residence.
CHAPTER XI
Distribution
Article 36
Wholesale distribution
1 — The wholesale distribution of medical devices is subject to the notification to the competent authority and the latter’s supervision according to the provisions of this decree-law.
2 — The notification is carried out at least 60 days in advance regarding the beginning of the wholesale distribution activity.
3 — The details that should be included and accompany the notification are established by regulation of the competent authority, to e issued within 90 days.
Article 37
Requirements for the wholesale distribution activity
1 — The activity of wholesale distribution of medical devices is permitted only in the case the concerned party has:
a) A supervisor ensuring the quality of the performed activities;
b) Suitable facilities and equipment and with suitable capacity to ensure the manufacture, storage and preservation of the medical devices, so as to comply with their performance and security requirements.
2 — The supervisor should have suitable technical qualification for the management and quality guarantee of the of the concerned wholesale distribution activity, as well as a suitable knowledge of the legislation and other regulations applicable to the concerned medical devices.
3 — The rules regarding good practices of wholesale distribution of medical devices are established by decree- order of the member of the Government in charge with the health department, to be issued within one year.
4 — Until the decree-order mentioned in the previous number is adopted the provisions of Decree-order no 348/98, of 15 of June, shall apply with the necessary adjustments, except for the provisions of the second paragraph of no. 1.1 of the annex of the mentioned decree-order.
Article 38
Preparatory Enquiries
The competent authority should check if the notification is submitted on a regular basis, requesting the
additional details and clarifications deemed necessary, otherwise the notification shall be declared void.
Article 39
Inspection
1 — For the purposes of the provisions of subparagraph b) of no. 1 of article 31, the competent authority, after checking the notification has been submitted on a regular basis, may decide on the need for an inspection of the facilities where the applicant intends to perform its activity.
2 — The inspection is intended to check the conformity of the facilities with the performance conditions required by this decree-law and other applicable regulations.
3 — In case the facilities are not compliant with the conditions required according to the provisions of the previous number, the concerned party is granted a timeframe not less than 30 days to correct the reported defects.
4 — In case the inspection does not take place within 60 days counting from the date the notification is received, the notifying party may start its activity, being subject to a subsequent inspection and the decision on that inspection.
5 — The timeframe mentioned in the previous number is deferred whenever the applicant is required to provide additional details or clarifications or carry out the correction of defects.
c) Keep the records of all transactions of medical devices carried out under the provisions of this decree-law for a period five years;
d) Distribute exclusively the medical devices which are compliant with the requirements of specific legislation required to be considered as suitable to be marketed;
e) Refuse the distribution of medical devices which have been ordered to be recalled by the competent authorities or so decided by the people legally responsible for its marketing;
f) Return to the manufacturer or supplier or destroy all medical devices which do not comply with the suitable legal conditions to be distributed, except if they can be used for other legitimate purposes and provided the non compliance is mentioned, in a legible and indelible way on the packaging or the labelling of the concerned product;
g) To provide the access of the supervision officers to the places, facilities and equipment mentioned in subparagraph
b) of no. 1 of article 37, as well as the documents and records which enable to check the compliance with the provisions of the subparagraphs of this number;
h) To comply with the surveillance obligations provided for in articles 27 and 28.
Article 40
Suspension and imposition of special conditions and obligations
1 — When it is reported that the notifying party does not comply with the requirements provided for in this decree-law and other applicable legislation, or the conditions of the respective notification, the competent authority should order the suspension of the performance of the wholesale distribution activity or impose special conditions or obligations o the notifying party.
2 — The decision mentioned in the previous number should include the respective grounds.
3 — The decision of suspension or the imposition of special conditions or obligations is legally challengeable, according to the law.
Article 41
Obligations of the dealer
1 — Notwithstanding the other obligations provided for in this decree-law, the individual performing the wholesale distribution activity of medical devices should:
a) Comply with the principles and good practices regarding distribution;
b) Notify, in writing, the competent authority on:
i) The list of marketed devices distributed by it, including the mention to the brand, group and type or model, description and the purpose it is intended for;
ii) The manufacturer’s name or corporate name and address or registered office and, in case the latter does not have an address or registered office in a member State, that of the respective representative;
iii) The changes to its name or corporate name and full address or residence and the other details of mandatory notification under the provisions of the previous subparagraphs;
2 — The records mentioned in subparagraph c) of the previous number should include, at least, the following details:
a) Date of transaction;
b) Name of the product and other identification;
c) Supplied quantity;
d) Corporate name or name and identification of registered office or the recipient and the supplier’s residence.
CHAPTER XII
Health protection
Article 42
Special measures of health protection
1 — Notwithstanding the provisions of article 29, the competent authority takes all necessary measures to guarantee the protection of health and safety as well as the respect for public health imperatives.
2 — For the purposes of the provisions of the previous number, the competent authority may order the recall of a device or a group of devices, or suspend, restrict or subordinate to specific conditions the latter’s coming into service or marketing.
3 — The reasoned decision is notified to the manufacture or its representative.
4 — The measures are also reported to the European Commission and the other member States, detailing the respective grounds.
CHAPTER XIII
Advertising
Article 43
Definition
1 — For the purposes of this decree-law, medical devices advertising is considered as any kind of information, survey or incentive with the object or to the effect of promoting its use,
prescription, supply, sale, purchase or consumption in any of the following circumstances:
a) Among the general public;
b) Among health professionals;
c) By means of the visit of sales of representatives of medical devices to people mentioned in the previous subparagraph;
d) By means of supplying samples to any of the people mentioned in subparagraphs a) and b);
e) By means of granting, offering or promising benefits in value or in kind, except when its intrinsic value is insignificant;
f) By means of sponsoring promotion meetings attended by health professionals;
g) By means of sponsoring congresses or meetings of scientific nature attended by health professionals, namely by paying, directly or indirectly, accommodation costs;
h) By means of mentioning the brand name of a medical device.
2 — Medical devices advertising may be carried out directly by the manufacturer of a medical device or, on former’s behalf, by a third party, notwithstanding the provisions of this decree-law.
3 — Medical devices advertising should:
a) Include details in compliance with the information provided by the instructions for use and the technical documents of the medical device;
b) Promote the safe use of the medical devices, in an objective way and without any exaggeration of their properties;
c) Not be misleading.
Article 44
Scope of exception
1 — This chapter does not apply to:
a) The labelling and instructions for use accompanying the medical devices;
b) The necessary correspondence to provide an answer to a specific question on a particular medical device, possibly accompanied with any document, provided it does not contain any advertising nature detail;
c) The specific information and reference documents regarding incidents warnings in the surveillance scope, as well as catalogues are and price lists, provided they do not contain any other information on the medical device;
d) Information regarding human health or human diseases, provided they do not mention, even indirectly, any medical device.
2 — Price lists and sales catalogue are considered as such when they show only the name, simple image, classification, package size and price of the medical devices.
3 — The lists and catalogues mentioned in the previous number including devices referred to in no. 2 of article 45 can only be disclosed among health professionals, wholesale dealers and users of medical devices.
Article 45
Prohibition
1 — Medical devices advertising is forbidden if those medical devices have not been subject to a conformity assessment under the provisions of articles 8 to 10 and the notification of the competent authority according to the provisions of article 11.
2 — Advertising among the general public for the use of medical devices which require a health professional’s mediation and decision such as implantable devices, long term invasive devices, devices which include as an integral part a medicinal product or a stable derivative from human blood and plasma and devices manufactured using cells and animal tissues is forbidden.
3 — The provisions of the previous number do not affect the promotion campaigns of medical devices approved by the competent authority for reasons of public interest.
4 — Exceptions to no. 2 of this article, included in the list to be approved by decree-order of the Government member in charge with the health department are permitted.
Article 46
Advertising among the public
1 — Advertising of medical devices among the public should be unequivocally identified as such, stating expressly that it is a medical device and including the information provided in the following number.
2 — Advertising among the public should include at least the following information:
a) Name of the medical device or trade mark;
b) Indispensable information for the safe use of the medical device, including purpose and special precautions;
c) Opinion to the user to read carefully the labelling and instructions for use.
3 — Advertising of medical devices among the public should not include any detail which:
a) Leads to conclude that medical appointment or surgical intervention is unnecessary, particularly suggesting a diagnosis or recommending correspondence treatment;
b) Suggests the effect of the medical device is guaranteed, with no adverse reactions or side effects, with better or equivalent results than other treatment with medical device or medicinal product;
c) Suggests the person’s normal health status may be improved by means of the use of the medical device;
d) Suggests the person’s normal health status may be impaired if the medical device is not used;
e) Addresses exclusively or mainly children;
f) Mentions a recommendation issued by scientists, health professionals or another person who, by his/her celebrity, may urge to the consumption of the medical devices;
g) Handles the medical device as a food product stuff, cosmetic product or hygiene product corporal or any other consumer good product;
h) Suggests that the safety or efficiency of the medical device is due to the fact of being considered a natural product;
i) May lead, by means of a description or a detailed representation of anamnesis, to a false self test;
j) Mentions, in an improper, scaring or misleading way, demonstrations or guarantees of cure;
l) Uses, in an improper, scaring or misleading way, visual representations of changes in the human body caused by diseases or injuries, or of the action of a medical device in the human body or in parts of the human body.
4 — Any form of comparative advertising is forbidden.
Article 47
Advertising among health professionals
The medical devices mentioned in no. 2 of article 45 may only be announced or advertised in technical publications or other media intended and accessible exclusively to physicians and other health professionals.
Article 48
Advertising material
1 — Documents conveyed to health professionals should state the date it was established or reviewed the last time. 2 — Information included in documents has to
be exact, updated, checkable and sufficiently complete to enable the recipient to have an accurate idea of the performance and safety of the medical device.
3 — The quotes and illustrative material taken from medical journal or scientific studies intended to be used in the documents should be accurately reproduced stating the respective source.
Article 49
Manufacturer’s obligations
1 — The manufacturer is under the obligation to create and keep a scientific service in charge with the information regarding medical devices it is responsible for.
2 — The manufacturer is also under the obligation to:
a) To keep full and detailed records o f a l l ad vertising carried out by the company, in forms mentioning the recipients, mode and date of the first disclosure;
b) To provide the records mentioned in the previous subparagraph to the authorities with supervisory powers for a period of five years, counted from the date provided for in the previous subparagraph;
c) To guarantee that the advertising carried out by the company or on its behalf and expenses complies with the obligations imposed by law;
d) To ensure the sales representatives that promote medical devices at its expenses or on its behalf have the suitable qualifications and professional training required for the suitable performance of their duties,
practicing their profession in full compliance with the respective obligations;
e) To create the required mechanisms to ensure the reception and processing of the information mentioned in no. 3 of the following article;
f) To cooperate with the public authorities with the due powers in the scope of this chapter, namely providing information and assistance necessary for the exercise of their powers;
g) To comply with the decisions adopted in the scope of this chapter, notwithstanding the challenging right provided by the law.
Article 50
Sales representatives of medical devices
1 — The sales representatives of medical devices should be suitably trained and have scientific knowledge and deontological training which enable them to provide precise information and as thorough as possible on the medical devices they show.
2 — The sales representatives of medical devices should, with each visit, show or provide to the health professional they call upon, as to each one of the medical devices they show, a copy of the respective label and instructions for use.
3 — The sales representatives of medical devices should notify the manufacturer or the company they have a contract with, immediately, any information regarding the use of the medical devices they promote, especially with respect to the incidents reported to them by the health professionals they call upon.
4 — The requirements necessary to practice the profession of sale representative of medical devices and respective job title are established by joint decree-order of the members of the Government in charge with the work, health and education departments to be issued within 180 days.
5 — The access scheme of sales representatives of medical devices to institutions and offices constituting NHS is established by decree-order of the member of the Government in charge with the health department to be issued within 60 days after the decree-order mentioned in the previous number is issued, who has to establish also the mechanisms and rules enabling the normal working of the offices and the transparency of the activity of the representatives.
Article 51
Bonus, gifts and other benefits
1 — The manufacturer, the company in charge with the information and promotion of a medical device, or the wholesale distributor is forbidden to give or promise, directly or indirectly, to health professionals, bonuses, gifts or benefits in value or in kind, except when it has to do objects of insignificant value and which are relevant to the health professional’s activity.
2 — Notwithstanding the provisions of the previous number, the health professionals are forbidden, on their behalf or by means of a third party to ask or accept, directly or indirectly, bonuses, gifts or benefits in value or in kind, provided by the manufacturer, the company in charge with the information and promotion of a medical device, or the
wholesale distributor, even if the former are received abroad under foreign legislation and regardless of any compensation regarding the supply, use, distribution or sale of medical devices by the mentioned entities.
3 — The meaning and scope of the exception provided for at the end of no. 1 may be established by decree-order of the member of the Government in charge with the health department.
4 — The payment of fees to health professionals for their active participation, namely when they deliver scientific papers in events of this nature or training courses and sessions for the promotion of medical devices is not considered to be a violation of the provisions of nos. 1 and 2 of this article, provided that, in any case, the mentioned payment does not depend on, or is the compensation of the use or distribution of medical devices.
Article 52
Transparency and advertising
1 — The sponsorship by any entity covered by this decree- law of congresses, symposiums or any direct or indirect sessions or events of scientific or dissemination nature of the medical devices mentioned in no. 2 of article 45, should be included in the promotion documents regarding the latter, as well as in all attendants’ documents and in works or reports issued after these sessions or events have taken place.
2 — The manufacturer or company in charge with the information and promotion regarding the medical device should keep the documents regarding each of the sponsored or organized events or sessions, even if indirectly.
3 — The above mentioned documents includes, in a through and fair way, the following details:
a) Program of sessions and events;
b) Identification of the entity or entities which carry out, sponsor and organize the sessions and events;
c) Copy of the delivered scientific or professional papers;
d) Map of expenditure and possible revenue as well as the respective documentary evidence.
4 — The documents mentioned in the previous numbers is kept for five years, counting from the event or session is concluded, and should be available to entities with supervisory powers.
Article 53
Scientific or promotional sessions
1 — The training, information or sales promotion sessions of the devices mentioned in no. 2 of article 45 can only be addressed to health professionals.
2 — The entities promoting or organizing sessions covered by the previous number may only bear the accommodation costs of the respective attendant entities and strictly limited to the main purpose of the session.
3 — The provisions of the pervious numbers applies also to sessions and events of an exclusively professional and scientific nature.
4 — The Minister of Health establishes the rules for the of NHS health professionals in the sessions and events covered by this article.
Article 54
Accommodation costs
1 — Accommodation costs are considered to be only the expenses with registration, travel and stay of the health professionals attending the sessions provided for in the previous article.
2 — Accommodation costs regarding the stay may not exceed the period between the day before the session or event starts and the following day after the event or sessions end nor include any program or activity of social nature likely to harm or prevent the full participation in sessions of scientific or professional nature.
3 — The choice of the venues to hold the scientific sessions and events provided for in the previous article, should comply with adjusted criteria form a professional and logistic point of view and involves, namely as to accommodation levels financial costs matching the aimed purposes.
Article 55
Free samples
1 — Free samples o f the medical d evices mentioned in no 2 of article 45 may only be given to health professionals qualified to decide on the use of the mentioned devices, exceptionally, provided the following conditions are simultaneously complied with:
a) They are the object of a duly signed dated and signed written request of the recipient;
b) They display words such as «Free sample» and
«Forbidden sale», or other similar ones;
c) They have a label and are accompanied with a copy of the instructions for use.
2 — Free samples o f med ical devices available to the general public shou ld co mpl y with the pro visions o f sub paragraphs b) and
c) of the previous number.
3 — The entities providing free samples are under the obligation to create a suitable control and accountability system, which should be available to the authorities with supervisory powers, for five years.
Article 56
Supervision
1 — In the scope of their supervisory powers, it is incumbent on the competent to examine the advertising of medical devices.
2 — The highest body of the competent authority establishes the criteria the supervision has to comply with, according to the provisions of this chapter.
3 — The highest body of the competent authority may, at its own initiative, upon request of another public or private entity or following a complaint:
a) To order the required provisional or final measures to prevent any advertising form which violates the provisions of this decree-law, even if not started, or to correct or rectify the effects of advertising already started among consumers and companies;
b) To examine, preventively, the compliance with the law of a particular advertising form or project.
4 — The issue or disclosure of forbidden advertising constitutes a crime of disobedience, according to the provisions of article 348 of the Penal Code, notwithstanding the administrative responsibility that takes place and the application of the suitable financial and administrative penalties, according to the provisions of this decree-law, or otherwise according to legislation on advertising.
Article 57
Subsidiary legislation
Advertising Code applies to everything that is not provided for in this chapter.
CHAPTER XIV
Databases and confidentiality
Article 58
European databases
1 — The information regarding the application of this decree-law is registered on an European database, available to competent authorities, including the following details:
a) Data regarding the manufacturers, representatives and the devices’ registration, according to article 11, with the exception of data regarding customised devices;
b) Data regarding issued, changed, completed or suspended, withdrawn or refused certificates, according to the procedures provided for in annexes II to VII, of this decree-law, of which they are an integral part, or, in the case of active implantable medical devices, in annexes X to XIV of this decree-law, of which they are an integral part;
c) Data obtained according to surveillance procedure established in articles 27 and 28;
d) Data regarding clinical researches mentioned in chapter V.
2 — While the European database to be regulated by decree-order of the member of the Government in charge with the health department is not implemented, the marketing or commissioning of any device is notified by the manufacturer or its representative to the competent authority, together with the details mentioned in no 3 of article 11.
Article 59
Confidentiality
1 — All information conveyed to the parties intervening in the execution of this decree-law are confidential, those who become aware of them being subject to confidentiality duty of secrecy, notwithstanding the disclosure of information required for public health safeguard.
2 — The provisions of the previous number does not harm the compliance with the obligations of competent authority of the notified bodies regarding reciprocal information and disclosure of warnings, nor the information duty which is incumbent on the concerned people in the scope of criminal law.
3 — The following information is not considered confidential:
a) Information on the registration of people in charge with marketing the medical devices, according to article 11;
b) Information intended for user conveyed by the manufacturer, the representative or the distributor related to measures under no. 3 of article 27;
c) I nformation included in issued, changed, complemented, suspended or withdrawn certificates.
CHAPTER XV
Supervision, offences, penatlies
Article 60
Competent authority and supervision
1 — INFARMED, I. P., is appointed as competent authority, for the purposes of this decree-law and the exercise of rights, obligations and powers that the community legal system grants to competent authorities of the member States, according to the applicable provisions of the law and community standards.
2 — Notwithstanding the powers granted by law to other entities and, in particular, to “Autoridade de Segu- rança Alimentar e Económica (ASAE)” (national authority for food and economic security) INFARMED, I. P., by means of its workers, officers or agents, carries out the supervision of the compliance with the provisions of this decree-law and the respective regulations, being allowed to turn to the services of third parties, when it comes to the clinical and laboratory assessment.
3 — The supervisory activity comprises the business places, institutions and units in national territory where the medical devices are manufactured, imported or exported from, distributed or used to provide health care.
4 — The powers mentioned in the previous numbers comprise devices intended for export, including those which are not compliant with the essential requirements provided for in annex I, of this decree-law of which it is an integral part, or in the case of active implantable medical devices, in annex X of this decree-law of which it is an integral part, or do not display the C marking and the supervision and follow-up of investigations of devices not displaying EC marking.
5 — The workers, officers or agents of INFARMED, I.
P. may collect samples of the medical devices provided it is in the scope and for the purposes of the provisions of the previous number.
6 — The owners administrators, managers, directors or representatives of the companies engaged in the manufacture, distribution, storage and sale of medical devices subject to the powers of INFARMED, I. P., and the institutions and units where those devices are used to provide health care should provide the agents and officers of the mentioned Authority with supervision powers mentioned in no. 1 the access to the branch of their business places and offices in all situations involving supervision actions providing them also, upon request, with the suitable and due information to enable this body to put in place the procedures deemed necessary.
Article 61 s) The opinion of the health ethics committee non compliant with the provisions of nos. 2 and 3 of
Offences and fines of article 14;
1 — The following situations constitute an administrative offence punishable with a fine of € 2000 to € 3740 or up to € 44 890, whether the agent is a legal person or corporate body:
a) Marketing, commissioning and trading of medical devices not compliant with essential requirements provided for in this decree-law;
b) The non-compliance with relevant requirements in terms of health preservation and safety regarding the devices intended by the manufacturer to be used in compliance with the provisions regarding individual protection equipment and this decree-law;
c) The non compliance with the provisions of no 2 of article 5, regarding devices which are also machines;
d) The non compliance with the provisions of no 5 of article 5;
e) The provision to patients of customised medical devices of classes IIa, IIb and III and active implantable ones not accompanied with the declaration mentioned in annexes VIII or XV of this decree-law of which they is an integral part;
f) The marketing of medical devices not compliant with the classification rules provided or in annex IX
of this decree-law, of which it is an integral part;
g) The marketing or trading of devices not displaying the EC marking, the unsuitable use of EC marking and the non compliance with this decree-law regarding EC marking;
h) The marketing or commissioning of devices not complying or suitably applying the conformity assessment procedures or without the preparation and availability of the applicable declarations;
i) He non compliance with the obligations provided for in nos. 6, 7and 13 of article 8;
j) The lack or insufficiency ofnotifications provided for in article 11 and the changes of mandatory notification details according to the provisions of the same article;
l) The absence of labelling and instructions for use written in Portuguese or its non compliance with no. 13 of annex I of this decree-law, of which it is an integral part, or, in the case of active implantable devices, with nos. 17, 18 and 19 of annex X of this article, of which it is an integral part;
m) Clinical researches carried out without the application of procedures mentioned in annexes VIII, XV and XVI of this decree-law, of which it is an integral part;
n) The use of medical devices in clinical researches outside the conditions provided for in this decree-law;
o) The non compliance with the notification duty to the competent authority provided for in no 2 of article 12;
p) Clinical research carried out when the competent authority has decided otherwise;
q) Clinical research carried out not in compliance with the provisions under which it was granted;
r) Clinical research carried out without the assenting opinion of the competent ethics committee for health or not compliant with the mentioned opinion;
t) The non compliance of the notification obligation provided for in no 1 of article 16 and the lack or insufficient justification in case of a deadline which is brought forward;
u) The non compliance of the provisions of articles 17, 18, 19 and 20;
v) The clinical research carried out or continued in test site not equipped with the suitable material and human means;
x) The resumption of the clinical research which has been suspended or interrupted by the competent authority’s instructions;
z) The violation of confidentiality and protection duties of the personal of the participants in the research;
aa) Carrying out the clinical research without the participant having been previously informed of the former’s objectives, risks, inconveniences and conditions under which the free and informed consent is given;
bb) The non compliance or faulty compliance by the notified body of the obligations incumbent on it pursuant to the provisions of article 22;
cc) The marketing and commissioning of medical devices not compliant with the provisions of chapter VII; dd) The non-compliance with the obligations regarding the surveillance of medical devices provided for in articles 27 and 28 and annex XX do of this decree-law of
which it is an integral part;
ee) The activities mentioned in no. 1 of article 30 and the wholesale distribution of medical devices not in compliance with the provisions of this decree-law;
ff) The violation of the duty to ensure in an effective way the technical responsibility of establishing the activities mentioned in no 1 of article 30 and the wholesale distribution of medical devices;
gg) The practice of the activities mentioned in no 1 of article 30 and the activity of wholesale distribution of medical devices when the latter has been suspended following the decision of the competent authority and the non compliance with the conditions or special obligations imposed by the competent authority, according to the provisions of no. 1 of article 34 and no. 1 of article 40;
hh) The violation of the minimum requirements regarding the medical devices and the principles and standards regarding good practices of distribution;
ii) The violation of the standards regarding the record of transactions of medical devices provided for in this decree-law;
xx) The lack of notifications provided for in subparagraph b) of no. 1 of article 41;
ll) The non compliance with the obligations provided for in subparagraphs d), e) and f) of no. 1 of article 41;
mm) The non compliance with the provisions of nos. 2 and 3 of article 43, nos. 1 and 2 of article 45,
nos. 1 and 2 of article 46, nos. 1 and 2 of article 47,
nos. 1 to 3 of article 48, nos. 1 and 2 of article 49, nos. 1,
2 and 4 of article 51 and in articles 52 to 54;
nn) The supply of free samples of medical devices in no compliance with the conditions provided in this decree-law;
oo) The breach of confidentiality regarding the technical nature of the certification procedures;
pp) The non-compliance with the duty to implement and apply the measures adopted by the competent authority, namely under articles 29 and 42;
qq) The non-compliance with the provisions of this decree-law regarding the exercise of the supervisory powers of the competent authority;
rr) The non-compliance with the provisions of articles 67 and 68.
2 — Negligence and attempt shall be punishable, the minimum and maximum amounts of penalty being reduced to half the amounts established in the previous numbers.
Article 62
Special rules on advertising
1 — The advertiser, the advertising agency or any other entity engaged in any advertising activity, the holder of the advertisement or the respective agent are subsidiarily punishable as authors and co-authors of the offences provided for in this decree-law.
2 — The decision for a penalty due to the violation of the duties provided for in chapter XIII may result in the issue, in the media and at the defendant’s expenses, of the essential elements of the sentence, as well as the suspension, for a period that may not exceed two years of the advertising of the device.
Article 63
Offence procedures and penalties
1 — To the offence procedures provided for in this decree-law apply subsidiarily the provisions of the general scheme of administrative offences, approved by Decree-Law no. 433/82, of 27 October, amended by Decree-Laws nos. 356/89, of 17 October, and 244/95, of
14 September, and Law no. 109/2001, of 24 December.
2 — The preparatory enquiries of offences procedures is incumbent on INFARMED, I. P., notwithstanding the intervention, within the respective powers, of other public entities.
3 — The application of penalties provided for in this decree-law is incumbent on the higher body of INFARMED, I. P.
4 — The yield of the penalties applied according to the provisions of this chapter is allocated to:
a) 10 % for the entity which has taken the minutes;
b) 30 % for INFARMED, I. P.;
c) 60 % for the State.
CHAPTER XVI
Cost of the acts and language
Article 64
Cost of the acts
1 — The cost of the acts and services that should be provided by the competent authority regarding the medical
devices, including those related to the notifications, clinical research and inspections, is as expense of the applicants, the table being established by decree-order of the member of the Government in charge with the health department after hearing, INFARMED, I. P, to be issued within 60 days.
2 — The cost of the acts and services that must be provided by INFARMED, I. P., as the notified body, is an expense of the applicants, the table being established by decree-order of the Ministry of Health after hearing, INFARMED, I. P, to be issued within 60 days.
.
3 — The revenue provided for in the previous numbers are intended to pay the expenditure resulting from the respective office.
Article 65
Language of the documents, details and information
1 — The documents, details and information to be submitted to the competent authority according to this decree-law and respective complementary legislation should be submitted in Portuguese or be accompanied by an official translation into the Portuguese language, except when this translation is expressly dismissed by INFARMED, I. P.
2 — The competent authority may allow some documents, details or information to be submitted in other languages, according to the regulation adopted by the former.
CHAPTER XVII
Provisions applying to devices for in vitro diagnosis
Article 66
Medical devices for in vitro diagnosis
1 — The following provisions of this decree-law apply, with the suitable adjustments, to devices for in vitro diagnosis and the exercise of the activities mentioned in no.1 of article 30 and of wholesale distribution of these devices:
a) Articles 27 and 28, regarding medical devices surveillance and National Service for Medical Devices Surveillance;
b) Articles 30 to 35, regarding the exercise of manufacture, assembling, packaging, execution, renewal labelling and sterilization activities;
c) Articles 36 to 41, regarding the wholesale distribution activity;
d) Articles 43 to 55, regarding medical devices advertising;
e) Article 58, regarding the competent authority’s supervisory powers;
f) Subparagraphs dd) to nn), pp) and qq) of no. 2 of article 61 and article 62.
g) Article 64 regarding the cost of acts and services to be provided by the competent authority regarding medical devices;
h) Article 65;
i) Article 69 regarding the institutions where the activities mentioned in no. 1 of article 30 and those of wholesale distribution are carried out and which are in operation at the date this decree-law comes into force.
Article 67
Medical devices for in vitro self-diagnosis
1 — The devices for in vitro self diagnosis may only be made available to the public by means of distribution in pharmacies or places where over the counter medicinal products (OTCMP) are sold.
2 — When the devices mentioned in the previous number are being distributed to the public the following information should be provided:
a) Advise on how to suitably use the device and correctly interpret the respective results;
b) Information on possible falsely positive results and the probability of their occurrence;
c) Advise on the measures to be taken in case of a positive, negative or indecisive result;
d) Advise to not take any medical measures without a consulting a health professional.
3 — In case the self-diagnosis is carried out by the pharmacist, physician or another health professional at the pharmacy of the selling point of the OTCMP at the appointment location it must be possible to guarantee the anonymity regarding the test that is carried out.
4 — Health professionals mentioned in no. 3 should have the suitable knowledge and training to carry out the concerned test.
Article 68
Devices for in vitro self-diagnosis of restrict use
1 — It is forbidden to provide directly to the public medical devices for in vitro self-diagnosis intended only for detection, confirmation and quantification of HIV, HTLV, hepatitis B, C and D infection markers marker of HIV infection, the establishment of tumour markers, the diagnosis of hereditary diseases, blood grouping and genetic screening.
2 — The use of the devices mentioned in the previous number is carried out under the responsibility of a duly qualified health professional.
3 — For the purposes of the provisions of the previous number a duly qualified health professional is considered to be the individual holding a recognized title of specialist in the field of clinical laboratory.
4 — The laboratory tests carried out with the devices mentioned in no. 1 should be the object of medical prescription, notwithstanding being used under the protection or the authorization of entities and bodies reporting directly to the Ministry of Health.
CHAPTER XVIII
Final and transitional provisions
Article 69
Deadlines
Unless otherwise provided for, all deadlines provided for in this decree-law are established as consecutive days, in compliance with the provisions of article 279 Code of Civil Procedure.
Article 70
Transitional rule
1 — The entities in charge with the activities mentioned in no. 1 of article 30 and the wholesale distribution of medical devices in institutions in operation at the date this decree-law comes into force should, within 180 days, start the procedure leading to the notification provided for in no. 1 of article 30 and no. 1 of article 36 with the competent authority º
2 — The non-compliance with the provisions of the previous number causes the closure of the institution by the competent authority.
Article 71
Amendment to Decree-Law no. 121/2002, of 3 May
Article 2 of Decree-Law no. 121/2002 of 3 May, amended by Decree-Laws nos. 332/2007, of 9 October, and 138/2008, of 21 July, has currently the following wording:
«Article 2
[…]
1 — . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 — . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 — . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
h) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
j) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
l) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
m) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
n) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
o) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
q) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
r) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
t) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
u) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
v) Decree-Law no. 189/2000 of 12 August, amended by Decree-Laws nos. 311/2002, of 20 December, and 76/2006 of 27 March, regarding the provisions of devices for in vitro diagnosis.
4 — . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 — . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . »
Article 72
Revoking rule
1 — The following statutes are revoked:
a) Decree-Law no. 78/97 of 7 April, amended by Decree-Law no. 76/2006 of 27 March;
b) Decree-Law no. 273/95 of 23 October, amended by Decree-Laws nos. 30/2003 of 14 February 76/2006, of 27 March and 36/2007, of 16 February;
c) Articles 15 and 17 of Decree-Law no. 189/2000 of 12 August, amended by Decree-Law no. 311/2002, of 20 December, and Decree-Law no. 76/2006, of 27 March except for no. 4 of article 17;
d) Decree-Law no. 129/2004, of 1 June;
e) Decree-order no. 342/97, of 21 May;
f) Decree-order n.º 196/2004, of 1 March.
2 — The mentions in legal or regulatory statutes in force to revoked rules are considered to be made to the corresponding rules of this decree-law.
Article 73
Coming into force
This decree-law comes into force on 21 March of 2010.
Visto e aprovado em Conselho de Ministros de 2 de
Abril de 2009. — Xxxx Xxxxxxxx Xxxxxxxx Xxxxx xx Xxx- sa — Xxxx Xxxxxx Xxxxxxx Xxxxx — Xxx Xxxxx Xxxxxxx Xxxxx.
Promulgated on 4 June of 2009. To To be published.
The President of the Republic, XXXXXX XXXXXX XXXXX. Countersigned on 8 June 2009.
The Prime-Minister, Xxxx Xxxxxxxx Xxxxxxxx Xxxxx xx Xxxxx.
ANNEX I
(mentioned in no. 4 of article 2)
Essential requirements
Group I
General requirements
1 — The devices must be designed and manufactured so that their use does not harm the patient’s clinical status nor their safety, the users’ health and safety or that of third parties, when the former are used under the conditions and for the purposes provided for, taking into consideration the possible risks associated with the use they are intended for are acceptable risks when compared with the benefit provided to patients and are compatible with a high degree of health protection and safety.
1.2 — For the purposes of the previous number, the following principles should be complied with:
1.2.1 — The reduction, as much as possible, of the risks resulting from errors with the use due to the ergonomic characteristics of the device and the environment under which the product should be operating (design taking into consideration the patient’s safety); and
1.2.2 — The consideration of the technical knowledge, the experience, education and training and, if that is the case, of the clinical and physical conditions of the concerned users (design for non-professional, professional, handicapped people or other users).
2 — The solutions adopted by the manufacturer in the design and manufacturing of the devices should be compliant with the safety principles, considering the generally accepted technical advances, and their choice should be compliant with the following principles, in ascending order of importance:
2.1 — To avoid or reduce the risks to the minimum possible (design and manufacture intrinsically safe);
2.2 — When appropriate to adopt the suitable protection measures, including, if necessary, alarm systems for risks which cannot be removed;
2.3 — To inform the users on residual risks due to insufficient protection measures taken.
3 — The devices should achieve suitability levels ascribed to them by the manufacturers and should be designed, manufactured and packed so as to be able to perform one or more of the tasks provided for in subparagraph u) of article 3 of decree-law of which this annex is an integral part, according to the manufacturer’s specifications.
4 — The characteristics and performance levels mentioned in nos. 1 to 3 of this annex should not beos changed whenever these changes may impair the patients’ clinical status and safety and, possibly, third parties, during the life cycle of the devices provided for by the manufacturer, when they are submitted to wear and tear resulting from normal use conditions.
5 — The devices should be designed, manufactured and packed so that their characteristics and performance levels, according to the intended use, do not undergo changes during storage and transport, taking into account the instructions and information provided by the manufacturer.
6 — The possible undesirable side effects should constitute acceptable risks taking into account the provided for suitability levels:
6.1 — The demonstration of compliance with the essential requirements should include a clinical assessment according to the provisions of annex XVI.
Group II
Requirements regarding the design and manufacture
Part I
Chemical, physical and biological properties
7 — In what concerns the chemical, physical and biological properties, the design and manufacture should comply with the below mentioned requirements:
7.1 — The devices should be designed and manufactured so as to ensure the characteristics and suitability levels mentioned in group I, «General requirements », in compliance with the following:
7.1.1 — The selection of used materials, namely in what concerns toxicity, and if that is the case, flammability;
7.1.2 — The reciprocal compatibility between used materials and the fabrics, the biological cells and the body fluids, taking into consideration the purpose of the device;
7.1.3 — Whenever applicable, the results of biophysical researches and the model which has previously shown to be valid.
7.2 — The devices should be designed, manufactured and packed so as to minimize the risks regarding
pollutants and residues s to the staff involved in transport, storage and use, as well as in what concerns patients, taking into account the purpose of the product, a special attention being paid to the exposed fabrics, as well as the duration of and frequency of that exposure.
7.3 — The devices must be designed and manufactured so as to make it possible to use them safely with the materials, substances and gases they come in touch during its normal use or routine procedures and, if they are intended for the administration of medicinal products, they should be designed and manufactured so as to be compatible with the concerned medicinal products, according to the provisions and constraints governing those products, so that their suitability level keeps its compliance with the provided for purpose.
7.4 — When a device includes, as an integral part, a substance, which when used separately, may be considered as a medicinal product according to the provisions of Decree-Law no. 176/2006, of 30 August,
which has transposed Directive no. 2001/83/CE, of the European parliament and the Council, of 6 November, and may impact the human body by means of a subsidiary action to that of the device, the quality, safety and usefulness of the substance should be checked, in a similar way as to the methods provided for in annex I of Directive no. 2001/83/CE, of European parliament and the Council, of 6 November,(annex I of Decree-Law no. 176/206, of 30 August).
7.4.1 — Regarding the substances mentioned in no. 7.4., the notified body, after checking the usefulness of the substance as part of the device and taking into consideration the purpose of the device, requests one of the competent authorities in the scope of Directive no. 2001/83/CE, of the European parliament and the Council, of 6 November, appointed by the Member States or to European medicines Agency (EMEA), which acts, namely by means of its committee in compliance with Regulation (CE) no. 726/2004, a scientific opinion as to the quality and safety of the substance, including the risk-benefit clinical profile of the incorporation of the substance in the device.
7.4.2 — When issuing the opinion mentioned in the previous number, the competent authority or EMEA takes in due account the manufacture process and the data related to the usefulness of
incorporating the substance in the device in compliance with what is established by the notified body.
7.5 — When a device incorporates, as an integral part, a substance derived from human blood, the notified body, after checking the usefulness of the substance as part of the device and taking into consideration the purpose of the device, requests from European Medicines Agency (EMEA), which acts, namely by means of its committee in compliance with Regulation (CE) no. 726/2004, a scientific opinion as to the quality and safety of the substance, including the risk-benefit clinical profile of the incorporation of the human blood substance in the device.
7.5.1 — When issuing the opinion mentioned in the previous number, EMEA takes in due account the manufacture process and the data related to the usefulness of incorporating the substance in the device in compliance with what is established by the notified body.
7.6 — Whenever changes are made to ancillary substance incorporated in a medical device, especially as to what concerns its manufacturing process, the notified body should be informed about the changes and should consult the relevant competent authority on medicinal products (that is, the one intervening in the initial appointment) so as to confirm the
that the quality and safety of the ancillary substance is kept, the competent authority taking into due account the data related to the usefulness of the incorporation of the substance in the medical device according to what was established by the notified body, so as to guarantee the changes do not have an adverse impact on the risk-benefit profile established for the addition of the substance to the device.
7.6.1 — Whenever the competent authority in respect of medicinal products (that is the one which has attended the initial appointment) received information on the ancillary substance likely to have repercussions on the known risk-benefit profile regarding the incorporation of the substance in the medical device, issued its opinion to the notified body to find out whether or not this information have an impact on the risk-benefit profile established regarding the incorporation of the substance
in the medical device, the notified body taking into due account the updated scientific opinion at the time of its evaluation of the conformity assessment procedure.
7.7 — Devices must be designed and manufactured so as to reduce to a minimum the risks set by the release of substances from the device, a special attention being given to carcinogenic, mutagenic or toxic to reproduction, in compliance with annex I of Directive 67/548/CEE,
of the Council, of 27 June, on the approximation of the laws, regulations and administrative provisions regarding the categorization, packing and labelling of hazardous substances. (Decree-Law no. 280-A/87, of 17 July, establishing measures regarding the notification of chemical substances and the classification, packing and labelling of hazardous substances; Decree-Law no. 82/95 of 22 April, transposing to internal legal order various directives which amend Directive no. 67/548/CEE, of the Council of 27 June, on the approximation of the laws, regulations and administrative provisions regarding the categorization, packing and labelling of hazardous substances; Decree-order no. 732- A/96, of 11 November, which approves the
Regulation on the Notification of Chemical Substances
and the Categorization, Packing and labelling of Hazardous Substances.)
7.7.1 — In the case of parts of the device (or the device itself) intended to administer medicinal products, body fluids or other substances in the human body and, or to remove them from the human body, or devices intended to transport and storing of those body fluids or substances, contain phtalates classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in compliance with annex I of Directive no. 67/548/CEE, of the Council, of 27 June, an indication showing it is a device containing phthalates should be displayed on the label of the device itself or the package of each unit, or if that is the case, on the sales packaging.
7.7.2 — If the use intended for these devices includes children, pregnant or breastfeeding women’s treatment the manufacturer should provide a specific justification for the use of these substances in respect of the compliance with the essential requirements, such as those included in this number and nos. 7.7 and 7.7.1, in technical documents and instructions for use on the residual risks for these groups of patients and, if that is the case the suitable precautionary measures.
7.8 — The devices should be designed and manufactured so as to reduce to a minimum the risks resulting from the unintentional introduction of substances in the device, taking into account the device itself and the nature of the environment it is intended to be used in.
Part II
Microbial infection and contamination
8 — As to microbial infection and contamination, the design and manufacture of the device should comply with the following requirements:
8.1 — The devices and respective manufacturing processes must be designed so as to remove or reduce, as much as possible, the patient, the user or third parties’ risk of infection, to enable its easy handling and, if that is the case, to minimize the contamination of the device by the patient, and vice-versa, during its use.
8.2 — Animal tissues should come from animals which have undergone veterinary controls and supervisory measures suitable for the intended use of the tissues, and the notified bodies should collect and keep this information on the geographic origin of the animals.
8.2.1 — Transformation, preservation, handling of tissues, cells and substances of animal origin as well as the trials they are subject to should be carried out under optimum safety conditions, guaranteeing, in particular, the safety against viruses and other transmissible agents by means of the application of validated methods of viral elimination or inactivation, during the manufacturing process.
8.3 — The devices to be provided in a sterile condition should be designed, manufacture and packed in a disposable packaging and, or, in compliance with suitable procedures, so that they are sterile at the time of their marketing and continue to be so in the conditions provided for storage and transport , until the protection ensuring the sterility is violated or open.
8.4 — The devices to be provided in a sterile condition should have been manufactured and sterilized according to a suitable and validated method.
8.5 — The devices intended to be sterile should be manufactured in suitable and controlled conditions, such as those of environmental nature.
8.6 — The packing system for non-sterile devices should be able to keep the product without deterioration of the provided for cleanness and in case they are intended to be sterilized, before use, they should minimize the risk of microbial contamination, as well as be suitable for the sterilizing method indicated by the manufacturer.
8.7 — The package and labelling of the device should enable the distinction between two identical and similar products sold under the sterile and non-sterile form.
Part III
Properties regarding the manufacture and environmental conditions
9 — The properties regarding the manufacture and environmental conditions should meet the following requirements:
9.1 — If a device is intended to be used together with other devices or equipment items, that set, including the connection system, should be secure and not impair the
performance provided for, with restriction to use being specified in the label or the instructions for use.
9.2 — The devices should be designed and manufactured so as to suppress or minimize as much as possible:
9.2.1 — The damage risk due to their physical features, including pressure-volume ratio
their size and, possibly, ergonomic features;
9.2.2 — The risks resulting from reasonably predicted environmental conditions, such as magnetic fields, external electrostatic influences , electrostatic discharges, pressure, temperature or pressure variations and acceleration;
9.2.3 — The risks of reciprocal interference with other devices normally used for researches or a particular treatment;
9.2.4 — The risks resulting from of used materials getting old or the loss of accuracy of any measuring or control mechanism, when maintenance or calibration is not possible (as in the case of implantable devices).
9.3 — The devices should be designed and manufactured so as to minimize the fire or explosion risks under normal conditions of use or in situation of first breakdown a special attention being paid to devices when their use involves exposure to flammable substances or substances likely to foster combustion
.
Part IV Measuring devices
10 — The design and manufacturing of measuring devices should comply with the following requirements:
10.1 — Measuring devices should be designed and manufactured so as to ensure a constancy and accuracy of the measurements within suitable limits, according to the purpose of the devices and the manufacturer’s indications.
10.2 — The measurement, control and reading scale should be designed according to ergonomic principles and according to the purposes of the devices.
10.3 — The measurements carried out by measuring devices should be expressed in legal units, in compliance with the provisions of the applicable laws.
Part V Radiation protection
11 — As far as radiation protection is concerned the following conditions should be complied with:
11.1 — The devices are designed and manufactured so as to reduce to a minimum level compatible with the intended objective the exposure of patients, users and third parties to radiation emission, without restricting the application of the prescribed doses as appropriate for therapeutic or diagnosis aims.
11.2 — In the case of devices designed to emit radiation levels with a specific medical purpose with a benefit considered to be higher than the risks inherent to emission, the user should be able to control the radiations, and such devices should be designed and manufactured so as to guarantee the
reproducibility of variable parameters and respective tolerances.
11.3 — The devices intended to emit potential hazardous visible or invisible radiations should be equipped, whenever possible, with visual or audible indicators for such emissions.
11.4 — The devices should be designed and manufactured so as to reduce as much as possible the exposure of patients, user and third parties to the emission of non intentional, stray or diffuse radiations.
11.5 — The instructions for use of the devices emitting radiations should include detailed information on the nature of the emitted radiations, the means of protection of the patient and the user, the way to avoid wrong handling and the risks inherent to the installation.
11.6 — The devices intended to emit ionising radiations should be designed and manufactured so as to guarantee, whenever possible, that the quantity, geometry and quality of the emitted radiation may be regulated and controlled according to the purpose.
11.6.1 — The devices emitting ionising radiations intended for radiological diagnosis should be designed and manufactured so as to provide a suitable image and, or of quality, for the intended medical purposes, ensuring, at the same time an exposure to radiations as low as possible both of the patient and the user.
11.6.2 — The devices emitting ionising radiations intended for radiotherapy should be designed and manufactured so as to enable a reliable supervision and control a of the administered doses, the type and energy of the beam, and if that is the case the quality of the radiation.
Part VI
Medical devices connected to an energy source or which are provided with it as equipment
12 — The requirements regarding medical devices connected to an energy source or that is provided with it as an equipment are the following:
12.1 — The devices integrating programmable electronic systems should be designed and manufactured so as to guarantee receptivity, reliability and the performance of those systems, according to the respective purpose, and in case of a breakdown, measures should be adopted to avoid, or mitigate as much as possible, the risks that can emerge from the latter, and regarding devices incorporating a software or being themselves a software aiming at a medical purpose, the latter should be validated according to state of the art, taking into consideration the life cycle principles, the development, the r isks management, validation and checking.
12.2 — The devices integrating an internal energy source on which depends the patient’s safety should be provided with the means to enable assessing the status of that source.
12.3 — The devices connected to an external energy source on which depends the patient’s safety should be provided with an alarm system indicating a possible power failure.
12.4 — The devices intended for the supervision of one or more clinical parameters of a patient de um should be provided with suitable alarm systems enabling to warn the user against situations that can cause death
or a serious deterioration of the patient’s health status.
12.5 — The devices should be designed and manufactured so as to minimize the risks resulting from electromagnetic fields likely to affect the operation of other devices or equipment installed in the environment.
A — Protection against electrical shock risks
12.6 — The devices should be designed and manufactured so as to prevent, as much as possible, the risks of non-intentional electric shocks under normal conditions of use and in situations of first breakdown, provided the devices are correctly installed.
B — Protection against mechanical and thermal risks
12.7 — For the protection against mechanical an thermal risks, the design and manufacturing of devices should comply with the following requirements:
12.7.1 — The devices should be designed and manufactured so as to protect the patient and the user against mechanical risks related, for instance, with the resistance, stability and movable parts.
12.7.2 — The devices should be designed and manufactured so as to minimize, as much as possible, the risks resulting from vibrations produced by the former, taking into account the technical progress and the possibility of reducing the vibrations, especially at the source, except when vibrations are part of the expected operation.
12.7.3 — The devices should be designed and manufactured so as to minimize, as much as possible, the risks resulting from the noise produced, taking into account the technical progress and the availability of means to reduce the produced noise, namely at the source, except if the sound emissions are part of the expected operation.
12.7.4 — The terminals and devices to connect to electrical power, hydraulic, pneumatic or gas sources that are to be handled by the user should be designed and manufactured so as to minimize the possible risks.
12.7.5 — Under normal operation conditions, accessible parts of the devices, excluding parts or areas intended to provide heat or reach certain temperatures and the surrounding environment, should not reach temperatures likely to be considered a risk under normal operation conditions.
C — Protection against risks inherent to the supply of energy or the administration of substances to the patients
12.8 — For the protection against risks inherent to the supply of energy or administration of substances to the patients the following requirements should be complied with:
12.8.1 — The design and manufacturing of devices intended for the supply of energy or the administration of substances to patients it should be possible to regulate the debit and keep it with sufficient precision to guarantee the patient and user’s safety.
12.8.2 — The devices should be provided with the means to prevent and, or, stress any debit disturbance which is likely to constitute a hazard, and the devices should incorporate suitable systems enabling, as much as possible, to prevent energy debits and, or, the substances supplied by the respective power supply to reach
accidentally dangerous levels.
12.8.3 — The control and indicators mode should be clearly displayed on the devices and, whenever a device comes with instructions for use or operation or regulation parameters by means of a visual system, this information should be clearly conveyed to the user, and if that is the case, to the patient.
Part VII
Information provided by the manufacturer
13 — As to the information provided by the manufacturer the following should be complied with:
13.1 — Each device should be accompanied with the information necessary for its correct and safe use and for the manufacturer’ s identification, taking into account the training and knowledge of the potential users, this information being included in the label and package insert.
13.2 — The information necessary for the use of the device in all safety should be, if possible and feasible, on the device itself and, or, the individual package, or also, on the trade package, but if the devices cannot information should be included in a package insert accompanying one or more devices.
13.3 — All devices should be accompanied with a package insert, inside the respective packages, notwithstanding the possibility of the mentioned insert package, exceptionally, not being included for classes I and II a devices, provided the respective safety of use may be guaranteed without the mentioned insert.
13.4 — Whenever suitable, information should be presented under the form of symbols, which together with the respective identification colours should be in compliance with the harmonised standards, or be described in the documents accompanying the device, in the fields where there are no standards at all.
A — Labelling
13.5 — Labelling should include in a legible and indelible manner the following information:
13.5.1 — The name, or business name and the address of the manufacturer, whilst for imported devices to be distributed in the European Union, the label, the outer package or the instructions for use should include the name and address of the representative of the manufacturer, whenever the manufacturer does not have a registered office within the European Union;
13.5.2 — Information strictly necessary to enable the user to identify the device and the contents of the package, especially, for the user;
13.5.3 —The word «Sterile», if applicable;
13.5.4 — The batch code, preceded by the Word
«Batch», or the series number, if applicable;
13.5.5 — The limit date for the use of the device under safety conditions, mentioning the year and the month, if applicable;
13.5.6 — An indication that the devices is to be used only once, whenever applicable, the indication from the manufacturer on the single use being uniform within the European Union.
13.5.7 — For customised devices the mention of
«Customised Device»;
13.5.8 — For devices intended for clinical research the mention of «Exclusively for clinical research»;
13.5.9 — Special storing or handling conditions;
13.5.10 — Special instructions for use;
13.5.11 — Warning or precautions’ to take;
13.5.12 — The manufacturing year for active devices not covered by the above mentioned no 13.5.5, this indication being included in the batch or series number;
13.5.13 — The sterilization method, if applicable;
13.5.14 — In the case of a device such as the one mentioned in the provisions of subparagraph
b) of no. 2 of article 2 of decree-law of which this annex is an integral part, the mention that the device incorporates as an integral part a substance derived from human blood.
13.6 — If the purpose provided for a device is not obvious for the user, the manufacturer should clearly specify it in the labelling and instructions for use.
13.7 — The devices and the detachable components should, if that is justifiable and feasible, be identified as to the batches, so as to enable carrying out actions to detect risks caused by the devices and the detachable components.
B — Instructions for use
13.8 — Whenever it is applicable, the instructions for use should include the following information:
13.8.1 — Indications mentioned in no.13.5, except for the ones included in nos. 13.5.4 and 13.5.5;
13.8.2 — The suitability levels mentioned in no. 3, as well as undesirable any side effects;
13.8.3 — If a device is to be installed or connected to other medical devices or equipment, to be operated according to the intended purpose, sufficient details on their features should be provided so as to enable identifying which devices or equipment items should be used to get a safe combination;
13.8.4 — All indications enabling to check if a devices is properly installed and may be operated correctly and in a completely safe manner, as well as the information regarding the nature and frequency of the maintenance and assessment operations to be carried out as to ensure always the correct operation and safety of the devices:
13.8.4.1 — The instructions for calibration and the maintenance manual, whenever applicable to the concerned products;
13.8.5 — Useful information to prevent certain risks resulting from the implantation of the device;
13.8.6 — Information regarding the risks of reciprocal interference resulting from the presence of the device when carrying out specific researches or treatments;
13.8.7 — Instructions necessary in case the package ensuring sterility is damaged and, if necessary, the indication of the suitable methods to carry out a new sterilization;
13.8.8 — If the device is reusable, information on
the suitable reusable procedures, including cleaning, disinfecting, packaging and, if that is the case, re-sterilization method, if the device has to be sterilized again, as well as any restrictions as to the number of times it is possible to reuse them;
13.8.9 — If the devices are provided with the condition of having to be previously sterilized, the instructions regarding cleaning and sterilization should be such as to guarantee that, if they are suitably complied with, the device is compliant with the general requirements mentioned in section I
of this annex;
13.8.10 — If the device is intended for a single use, information on the known features and technical factors the manufacturer is aware of and that may constitute a risk in case the device is used again and, if in compliance with 13.3 no instructions for use are necessary, information should be provided to the user, upon his request;
13.8.11 — In case a device should be submitted to an additional treatment or operation before being used (for instance sterilization, final assembly, etc.) the indications for that treatment or operation;
13.8.12 — In case a device emits radiations for medical purposes, the information regarding the nature, type, intensity and distribution of the mentioned radiations.
13.9 — The instructions for use should also include information enabling the medical staff to inform the patient on the contraindications and precautions to take, and this information should include in particular:
13.9.1 — The precautions to take in case the operation of the device is changed;
13.9.2 — The precautions to take with respect to the exposure, in reasonably predictable environmental conditions to magnetic fields, the external electrical influences, electrical discharges, the pressure or the pressure variations, acceleration, thermal sources of ignition, etc.;
13.9.3 — Suitable information on medicinal products which the concerned device is intended to administer, including any limitations to the choice of those substances;
13.9.4 — The precautions to take in case the device shows any special or abnormal risk regarding its disposal;
13.9.5 — The medicinal products or substances derived from human blood incorporated in the device as its integral part, I compliance with nos. 7.4 and 7.5;
13.9.6 — The accuracy required by measurement devices;
13.9.7 — The date of publication or review of the instructions for use.
ANNEX II
[mentioned in sub-subparagraph i) of subparagraph a) of no. 1 of article 8.º]
Declaration of conformity
Complete quality assurance system
1 — The manufacturer should apply the quality assurance system approved for the design, manufacturing and final control of the concerned products, such as it is specified in no. 4, being subject to checking provided for in no. 5 C supervision provided for in no. 6.
2 — The EC declaration of conformity is the procedure through which the manufacturer which com plies with the requirements provided for in the previous number, states and guarantees that the concerned devices are compliant with the applicable provisions of decree-law of which this annex is an integral part.
3 — The manufacturer should affix the EC marking according to article 7 of decree-law of which this annex is an integral part and prepare a declaration of conformity, in writing, which should cover one or more devices clearly identified by the name of the product, the code of the product or another unequivocal reference, and to be kept by the manufacturer.
Part I
Quality system
A — Assessment request
4 — The manufacturer should submit an assessment request of its quality system to the notified body.
4.1 — The request should include the following details:
a) The manufacturer’s name and address and any other manufacturing places covered by the quality system;
b) All information regarding the products and product categories the process applies to;
c) A written declaration stating that an equivalent application has not been submitted to any other notified body with respect to the same quality system;
d) The documents regarding the quality system;
e) The manufacturer’s commitment to comply with the obligations resulting from the approved quality system;
f) The manufacturer’s commitment to keep the approved quality system suitable and updated;
g) The manufacturer’s commitment to create and update a process of systematic analysis of the experience acquired with the devices in post-production stage, including the provisions mentioned in annex XVI, and to develop suitable means to implement any required corrections, a commitment which includes the obligation of the manufacturer to inform the competent authorities on the incidents mentioned in article 27 of this decree-law, as soon as it becomes aware of them.
4.2 — The application of the quality system should guarantee the conformity of the devices with the provisions of this decree-law applying to them at all stages, from design to final controls and includes, in particular, the documents regarding data and records resulting from the procedures mentioned in no 4.4.3.
B — Documents
4.3 — All details, requirements and provisions adopted by the manufacturer regarding its quality system should be included in documents organized systematically and orderly according to written guidelines and procedures, as, for instance, programs, plans, manuals and quality records.
4.4 — The documents mentioned in the previous number should, in particular, describe suitably:
4.4.1 — The manufacturer’s quality objectives;
4.4.2 — The organization of the company and namely:
4.4.2.1 — The organizational structures, the responsibilities of the staff their organizational skills in terms of the quality of the design and manufacture of the products;
4.4.2.2 — The methods enabling to control the efficient operation of the quality system, and namely its capacity to achieve the requested quality in what concerns the design and manufacture of the products, including the control of the non compliant products;
4.4.2.3 — If the design, the manufacture or the inspection and final tests of the products and their components are carried out by third parties, the control methods of the efficient operation of the quality system , especially, the type and scope of the control applied to those third parties;
4.4.3 — The procedures intended to control and check the design of the products, including the corresponding documents, and namely:
4.4.3.1 — A general description of the product, including the provided for alternatives, as well as their purposes;
4.4.3.2 — The specification of the design, including the standards which are applied and the results of the risk analysis, as well as the description of the adopted solutions to meet the essential requirements which apply to the products, whenever the standards mentioned in article 5.o are not applied integrally;
4.4.3.3 — The control and checking techniques of the design and procedures and the measures which are systematically used for the design of the products;
4.4.3.4 — The checking that when a device should be connected to another one or other ones to be able to be operated according to the respective purpose, the mentioned device meets the essential requirements when connected to a device or devices of the concerned type with the features indicated by the manufacturer;
4.4.3.5 — A declaration stating whether the device includes or not, as an integral part, a substance which, when used on its own, may be considered as a medicinal product or a substance derived from human blood mentioned in nos. 7.4 and 7.5 of annex I, as well as the date regarding the tests carried out for that purpose and which are required to assess the safety, quality and usefulness of that substance or the substance derived from human blood, taking into account the purpose of the device;
4.4.3.6 — A declaration stating whether or not animal tissues are used for the manufacturing of the device, such as they are mentioned in Directive no. 2003/32/EC of the Commission of 23 April, and in chapter VII of decree-law of which this annex is an integral part;
4.4.3.7 — The adopted solutions, such as they are mentioned in no. 2 of chapter I of annex I;
4.4.3.8 — Pre-clinical assessment;
4.4.3.9 — Clinical assessment mentioned in annex
XVI;
4.4.3.10 — The labelling project and, if suitable, of the instruction of use;
4.4.4 — The techniques of control and guarantee of the quality, at the manufacture level and namely:
4.4.4.1 — The processes and procedures used, namely in terms of sterilization, purchases and relevant documents;
4.4.4.2 — The identification procedures of the product established and updated from drawings, specifications or other relevant documents for all manufacturing stages;
4.4.5 — Of checks and suitable tests carried out before, during and after the manufacture, the frequency as the former are carried out and the test equipment used ensuring in an appropriate way the calibration of the test equipment items.
C — Notified body
4.5 — The notified body carries out a check of the quality system to establish whether the latter meets the requirements provided for in nos. 4.1 to 4.4 and assumes the compliance with those requirements, if the system applies the corresponding harmonized standards.
4.6 — The auditing team in charge with the assessment should include, at least, one element with due experience and knowledge in the assessment of the concerned technology, and the assessment procedure should include:
i) An assessment, on a representative basis, of the documents of the design of the concerned product or products;
ii) An inspection to the manufacturer’s facilities and ins duly justified case, to those of the suppliers and or the manufacturer’s sub-contractors with a view to check the manufacturing processes.
4.7 — The decision should be notified to the manufacturer and contains all conclusions of the inspection and a reasoned assessment.
4.8 — The manufacturer should inform the notified body which has approved the quality system of any project of significant changes of the latter or the variety of covered products, and the notified body should assess the changes and check if the quality system changed accordingly, still meets the requirements mentioned in nos. 4.1 to 4.4, notifying the manufacturer on its decision, with all the conclusions of the inspection and a reasoned assessment.
Part II
Review of the product’s design
5 — In addition to the obligations which are incumbent on it, pursuant to no. 4, the manufacturer should submit to the notified body a request for the review of the file of the design regarding any product to be manufactured, according to the provisions of this number.
5.1 — The request should describe the design, the manufacture and the features of the concerned product, including the details necessary for the assessment of its conformity with the requirements of this decree-law, as mentioned in no. 4.4.3.
5.2 — The notified body should examine the request and, in case the product is in conformity with the applicable provisions of this decree-law should issue to the applicant an EC-type examination certificate for the design.
5.3 — The notified body may require that the request is completed with tests or additional proof enabling to assess the conformity with the requirements of this decree-law.
5.4 — The certificate should include the conclusions of the examination, the conditions of its validity, the necessary data for the identification of the approved design and a description of the purpose of the product, if necessary.
5.5 — In the case of the devices mentioned in no. 7.4 of the annex, before making a decision, the notified body
should consult, as to the aspects mentioned in this number, with one of the competent authorities appointed by the Member states according to Directive no. 2001/83/C, of the European Parliament and the Council, of 6 November or EMEA.
5.5.1 — The opinion of the national competent authority consulted or EMEA, mentioned in the previous number is given within 210 days after receiving all valid documents.
5.5.2 — The scientific opinion of the consulted national competent authority or EMEA issued according to nos. 5.5 and 5.5.1 should be included in the documents regarding the device.
5.5.3 — The notified body takes into due account for its decision the opinions given during the consultation mentioned in no 5.5.
5.5.4 — The notified body informs the consulted national competent authority on its final decision.
5.6 — In the case of the devices mentioned in no 7.5 of annex I, EMEA’s scientific opinion should be included the documents regarding the device.
5.6.1 — EMEA’s scientific opinion mentioned in the previous number is given within 210 days after all valid documents are received.
5.6.2 — The notified body takes into due account for its decision the EMEA’s opinion.
5.6.3 — The notified body cannot issue th e certificate i f EMEA’s scientific opinion is adverse.
5.6.4 — The notified body informs EMEA on its final decision.
5.7 — In the case of medical devices manufactured using animal tissues mentioned in Directive no. 2003/32/CE, of the Commission of 23 April, and chapter VII of decree-law of which this annex is an integral part, the notified body should comply with the procedures mentioned in such Directive.
5.8 — Changes introduced in the approved design should receive a full approval of the notified body which has issue the EC-type examination certificate for the design, whenever those changes may impact the conformity with the essential requirements of this decree-law or the conditions established for the use of the product, and the applicant should inform the notified body issuing the certificate the EC-type examination certificate for the design of any change included in the approved design.
5.9 — The additional approval must be given as an amendment to the EC-type examination certificate for the design.
Part III
Supervision
6 — The purpose of the supervision is to ensure that the manufacturer complies correctly with the obligations resulting from the approved quality system.
6.1 — The manufacturer should authorize the notified body to carry out all necessary inspections and to provide it with suitable information, especially:
6.1.1 — Documents regarding the quality system;
6.1.2 — The data provided for in the part of the quality system regarding the design, namely the results of the analysis, calculations, trials, the solutions adopted as mentioned in no. 2 of annex I, the clinical and pre- clinical assessment, the clinical post-marketing follow-up plan, as well as, the results of the follow-up, if that is the case.
6.1.3 - Quality system data regarding the manufacture, such as inspection reports and trial data, calibration data, quality reports of the involved staff, etc.
6.2 — The notified body should carry out the suitable inspections and assessments so as to certificate that the manufacture applies the approved quality system, and should deliver an assessment report to the manufacturer.
6.3 — The notified body may carry out unannounced visits to the manufacturer, during which, if deemed necessary, it may carry out verification tests of the quality system, or have them carried out, and should hand over to the manufacturer an inspection report and a report of the tests carried out.
Part IV
Administrative provisions
7 — During at least five years and, in the case of implantable devices, at least during 15 years, counting from the date of the last product manufactured, the manufacturer, or its representative, should make available to the competent authority:
7.1 — The declaration of conformity;
7.2 — All documents mentioned in subparagraph d) of no 4.1, especially, the documents, data and records mentioned in no 4.4;
7.3 — The changes mentioned in no. 4.8;
7.4 — The documents mentioned in no 5.1;
7.5 — The decisions and reports of the notified body mentioned in nos. 4.5, 5.2, 5.8, 6.2 and 6.3.
Part V
Application to devices of classes IIa and IIb
8 — This annex applies to products of classes IIa and IIb, according to the provisions of subparagraph b) and c) of no. 1 of article 8 of decree-law of which this annex is an integral part; above mentioned part II does not apply to them.
8.1 — In the case of class IIa devices, the notified body assesses, in the scope of the assessment provided for in no 4.5, the technical documents mentioned in no 4.4.3 regarding, at least, a sample representing each subcategory of the device, the respective compliance with the provisions of this decree- law.
8.2 — In the case of class IIb devices, the notified body assesses, in the scope of the assessment provided for in no 4.5, the technical documents mentioned in no 4.4.3 regarding, at least, a sample representing each generic group of the device, the respective compliance with the provisions of this decree- law.
8.3 — When choosing the representative sample or samples, the notified body takes into consideration the new technology, the similarities of the design, technology and methods of manufacture and sterilization, the purpose and the results of any previous relevant assessments (namely on the physical, chemical or biological properties) that have been carried out in compliance with this decree-law.
8.3.1 — The notified body documents and keeps at the disposal of the competent authority the analysis of the chosen samples.
8.4 — The notified body carries out the assessment of other samples in the scope of the supervision mentioned in the above part III.
Part VI
Application to devices incorporating a substance derived from human blood according to what is provided in subparagraph b) of no. 2 of article 2.
9 — After concluding the manufacturing of each batch of the device mentioned in subparagraph
b) of no. 2 of article 2 of decree-law of which this annex is an integral part, the manufacturer informs the notified body of the validation of that batch, sending the former the official certificate of the validation of the batch of the substance derived from human blood used in that device, prepared and worded by the appointed laboratory, according to the provisions of no. 2 of article 114 of Directive no. 2001/83/EC, of the European Parliament and the Council, of 6 November (article 135, no. 4, of Decree-Law no. 176/2006, of 30 August).
ANNEX III
[mentioned in sub-subparagraph ii) of subparagraph a) of no. 1 of article 8]
3.3 — The necessary descriptions and explanations for the comprehension of the mentioned drawings and diagrams of the operation of the device;
3.4 — A list of the standards mentioned in article 6 and the decree-law of which this annex is an integral part 3.5
— The results of the design calculations the risk analysis, the carried out examinations and technical tests, etc.;
3.6 — A declaration stating whether or not the device includes as an integral part any substance which, if used separately, is considered to be a medicinal product or a substance derived from human blood, mentioned in nos. 7.4 to 7.5 of annex I, as well as the data regarding the tests carried out for the purpose and which are necessary to assess the safety, quality and usefulness of that substance derived from human blood, taking into account the purpose of the device;
3.7 — A declaration stating whether or not animal tissues are used in the manufacture of the device such as mentioned in Directive n.º 2003/32/EC, of the Commission of 23 April, and in chapter VII of decree-law of which this annex is an integral part;
3.8 — The adopted solutions, such as they are mentioned in no. 2 of annex I;
3.9 — The pre-clinical assessment;
3.10 — The clinical assessment mentioned in annex
XVI;
3.11 — The labelling project for the instructions for use.
EC-type Examination
1 — EC-type examination is the procedure by means of which the notified body checks and certifies that a representative sample of the provided for production complies with the applicable provisions of this decree-law.
A —Examination application
2 — The EC-type examination application should include:
2.1 — The manufacturer’s name and address and if the application is submitted by the latter’s representative, its name and address;
2.2 — The documents mentioned in no 3, necessary for the conformity assessment of the specimen representing the provided for production, hereinafter referred to as
«type», with the requirements of this decree-law, and the applicant should keep one type at the disposal of the notified body which may request the number of specimen deemed necessary;
2.3 — A written declaration stating that no other application for the same type was submitted to another notified body.
B — Documents
3 — The documents should enable to understand the design, the manufacture and the performance of the product and include, namely the followingdetails:
3.1 — A general description of the type, including any provided for alternatives, as well as their purposes;
3.2 — The drawings of the design, including the provided for manufacture methods, namely in terms of sterilization, the diagrams of components, subsets and circuits fully or partially adopted, as well as the description of the adopted solutions to meet the essential requirements which apply to the products, whenever they have not been applied integrally;
C — Notified body
4 — The notified body should:
4.1 — Review and assess the documents and check if the type was manufactured in compliance with those documents, as well as register the elements which have been designed according to the applicable provisions in the standards mentioned in article 6 of the decree-law of which this annex is an integral part as well as the elements whose design is not based on the relevant provisions of the mentioned standards;
4.2 — To carry out the suitable controls and tests to check if the solutions adopted by the manufacturer meet the essential requirements of this decree-law or have them carried out, in cases when the provisions of article 6 of the decree-law of which this annex is an integral part has not been applied;
4.3 — In case a device has to be connected to another one or other ones to be able to be operated according to the respective purpose, evidence should be shown on the compliance of the first of these devices with the applicable essential requirements when connected to a device or devices of the concerned type with the features indicated by the manufacturer;
4.4 — To carry out the necessary tests or have them carried out to check if the relevant standards were effectively applied in cases when the manufacturer chooses to apply them;
4.5 — To agree with the applicant on the place where to necessary inspections and tests are to take place.
5 — If the type meets the provisions of this decree- law, the notified body issues the EC-type examination certificate to the applicant, which includes the manufacturer’s name and address the inspection conditions, the validity conditions of the certificate and the necessary data to identify the approved type, and the significant parts of the documents should be attached to the certificate and the notified body should keep a copy
5.1 — In the case the devices mentioned in no 7.4 of
annex I, before making a decisions the notified body should consult, as far as the aspects mentioned in this number are concerned, one of the competent authorities appointed by the member States according to the provisions of Directive no. 2001/83/CE, of the European Parliament and the Council of 6 November, or EMEA.
5.1.1 — The opinion of the consulted national competent authority or EMEA, is given within 210 days after receiving all valid documents.
5.1.2 — The scientific opinion of the consulted national competent authority or EMEA should be included in the documents regarding the device..
5.1.3 — The notified body takes into due account for its decision the opinions given during this consultation.
5.1.4 — The notified body informs the consulted national competent authority on its final decision.
5.2 — In the case of the devices mentioned in no 7.5 of annex I, EMEA’s scientific opinion should be included the documents regarding the device.
5.2.1 — EMEA’s scientific opinion is given within 210 days after all valid documents are received.
5.2.2 — The notified body takes into due account for its decision the EMEA’s opinion.
5.2.3 — The notified body cannot issue the certificate i f EMEA’s scientific opinion is adverse.
5.2.4 — The notified body informs EMEA on its final decision.
5.3 — In the case of medical devices manufactured using animal tissues mentioned in Directive no. 2003/32/CE, of the Commission of 23 April, and chapter VII of decree-law of which this annex is an integral part, the notified body should comply with the procedures mentioned in such Directive.
6 — The applicant should notify the notified body issuer of the EC-type examination certificate of any significant changes introduced in the approved product.
6.1 — Changes introduced in the approved product should receive an additional approval of the notified body which has issued the EC-type examination certificate for the design, whenever those changes may impact the conformity with the essential requirements or the conditions established for the use of the product, and such approval is granted, whenever applicable, as an amendment to the initial EC-type examination certificate.
D —Administrative provisions
7 — The notified body should keep at the disposal of other notified bodies, as well as supervisory entities, upon request, all relevant information regarding EC- type examination certificates and the respective amendments, issued, refused or withdrawn.
7.1 — The other notified bodies may obtain a copy of EC-type examination certificates or their amendments, the annexes of these certificates being at the disposal of other notified bodies upon reasoned request and after notification to the manufacturer.
7.2 —The manufacture or its representative should keep together with the technical documents, a copy of the EC- type examination certificates and the respective amendments for at least 5 years counting from the manufacture of the last device.
7.3 — In the case of implantable devices, the period mentioned in the previous number is, at least, 15 years counting from the manufacture of the last device.
ANNEX IV
[mentioned in sub-subparagraph ii) of subparagraph a) of no. 1 of article 8]
EC Verification
1 — EC verification is the procedure whereby the manufacturer or his authorized representative ensures and declares that the products which have been subject to the procedure set out in Section 4 conform to the type described in the EC type-examination certificate and meet the requirements of this decree-law which apply to them, of which this annex is an integral part.
2 — The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and to the requirements of the decree-law which apply to them, of which this annex is an integral part, and affix the CE marking according to article 7 of the decree-law of which this annex is an integral part on each device and draw up a declaration of conformity.
2.1 — Before the start of manufacture, the manufacturer must prepare documents defining the manufacturing process, in particular as regards sterilization where necessary, together with all the routine, pre-established provisions to be implemented to ensure homogeneous production and, where appropriate, conformity of the devices with the type described in the EC type-examination certificate and with the requirements of this decree-law which apply to them and of which this annex is an integral part.
2.2 — In addition to the provisions of nos. 2 and 2.1, for products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions of Annex V, sections I and II.
3 — The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions mentioned in annex XVI and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the incidents mentioned in article 27 immediately on learning of them.
4 — The notified body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of this decree-law either by examining and testing every product as specified in no. 5 or by examining and testing products on a statistical basis as specified in no. 6, as the manufacturer decides. The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility.
Verification by examination and testing of all products
5 — Every product is examined individually and the appropriate tests defined in the relevant standards mentioned in article 6 of the decree-law of which this annex is an integral part, or equivalent tests must be carried out in order to verify, where appropriate, the
of the decree-law which apply to them.
5.1 — The notified body must affix, or have affixed its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out.
Statistical Verification
6 — The manufacturer must present the manufactured products in the form of homogeneous batches.
6.1 — A random sample is taken from each batch. The products which make up the sample are examined individually and the appropriate tests defined in the relevant standards referred to in Article 6 of this decree- law of which this annex is an integral part, or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of this decree-law which apply to them, in order to determine whether to accept or reject the batch.
6.2 — Statistical control of products will be based on attributes, and or variables, entailing a sampling system with operational features ensuring a high level of performance safety according to the state of the art. The sampling method will be established by the harmonized standards referred to in article 6 of the decree-law, of which this annex is an integral part, taking into account the specific nature of the product categories in question.
6.3 — If the batch is accepted, the notified body affixes or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may he put on the market except any in the sample which failed to conform.
6.4 — If a batch is rejected, the competent notified body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification.
6.5 — The manufacturer may, on the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
Administrative provisions
7 — The manufacturer or his authorized representative must, for a period ending at least five years, and 15 years in the case of implantable devices, after the last product has been manufactured, make available to the national authorities:
7.1 — the declaration of conformity;
7.2 — documents mentioned in no. 2;
7.3 — the certificates mentioned in nos. 5.1 and 6.3, and where appropriate, the EC type-examination certificate referred to in annex Ill.
Application to devices in class IIa
8 — In line with Article 11 (2), this Annex may apply to products in Class Ila, in compliance with subparagraph c) of no. 1 of article 8 of the decree-law of which this annex is an integral part, subject to the following exemptions:
8.1 — In derogation nos. 1 and 2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class lIa are manufactured in conformity with the technical documentation referred to in no. 3 of Xxxxx XXX and meet the requirements of this decree-law which apply to them
8.2 — In derogation from nos. 1, 2, 5 and 6, the verifications conducted by the notified body are intended to confirm the conformity of the products in Class IIa with the technical documentation referred to in no. 3 of Xxxxx XXX.
Application to devices incorporating a substance deriving from human blood according to subparagraph b) of no. 2 of article 2.
9 — In the case provided for in no. 5, once concluded the manufacture process of each batch of the device of the type mentioned in subparagraph b) of no. 2 of article 2 of the decree- law, of which this annex is an integral part and in the case of verification provided for in no 6 of this annex, the manufacturer informs the notified body on the validation of this batch, sending him the official validation certificate of the batch of the substance derived from human blood used in that device, prepared and drawn up by the laboratory appointed according to the provisions of no. 2 of article 114 of Directive no. 2001/83/CE, of the European Parliament and the Council, of 6 November (article 135, no. 4, of Decree-Law no. 176/2006 of 30 August).
ANNEX V
[mentioned in sub-subparagraph ii) of subparagraph a) of no. 1 of article 8]
EC Declaration of Conformity
Guarantee of manufacturing quality
1 — The manufacturer must apply the approved manufacturing quality system to and must carry out the final control of the concerned devices according to what is established in no 3, and i s sub ject to supervision pro vid ed for in no 4.
2 — The declaration of conformity is the procedure by means of which the manufacturer who complies with the obligations mentioned in no. 1 guarantees and declares the concerned devices are in conformity with the type described in the EC-type examination certificate and the provisions of this decree- law that apply to them.
2.1 — The manufacturer affixes the EC marking according to the provisions of article 7 of decree-law of which this annex is an integral part and prepares a written declaration of conformity comprising one or more manufactured medical devices, clearly identified by the name of the product, the code of the product or another unequivocal reference and files it.
Part I
Quality system
A — Request of assessment
3 — The manufacturer should submit an assessment request of its quality system to a notified body.
3.1 — The request mentioned in no. 3 above should include:
3.1.1 — The manufacturer’s name and address and any other manufacturing places covered by the quality system;
3.1.2 — All information regarding the products and product categories the process applies to;
3.1.3 — A written declaration stating that an equivalent application has not been submitted to any other notified body with respect to the same products;
3.1.4 — The documents regarding the quality system;
3.1.5 — The manufacturer’s commitment to comply with the obligations resulting from the approved quality system;
3.1.6 — The manufacturer’s commitment to keep the approved quality system suitable and efficient;
3.1.7 — n some cases, the technical documents regarding the approved types and a copy of the EC-type examination certificate;
3.1.8 — The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions mentioned in annex XVI and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the incidents mentioned in article 27 of this decree-law immediately on learning of them.
3.2 — The application of the quality system must ensure the conformity of the devices with the type described in the EC- type examination certificate ad the provisions of this decree- law which apply to them.
B — Documents
3.3 — All details, requirements and provisions adopted by the manufacturer in respect of its quality system should be included in the documents organized in a systematic and ordered manner as written guidelines and procedures, such as, for instance, programs, plans, manuals, quality records, and all these documents should include, in particular, a suitable description of:
3.3.1 — The manufacturer’s quality objectives;
3.3.2 — The organization of the company and in particular:
3.3.2.1 — The organizational structures, the responsibilities of the staff and their organizational skills in terms of the products’ quality of the design and manufacture;
3.3.2.2 — The methods enabling to control the efficient operation of the quality system, mainly its capacity to achieve the required quality of the products not in conformity;
3.3.2.3 — In case the manufacture or final inspection or tests are carried out by a third party of the methods of control and efficiency of the operation of the quality system and, in particular the type and scope of the applied control applied by those third parties;
3.3.3 — The quality control and guarantee procedures as for manufacture, namely:
3.3.3.1 — The processes and procedures used, namely in terms of sterilization, purchases and relevant documents;;
3.3.3.2 — The identification procedures of the product established and updated from drawings, specifications or other relevant documents for all manufacturing stages;
3.3.3.3 — Of checks and suitable tests carried out before, during and after the manufacture, the frequency as the former are carried out and the test equipment used ensuring in an appropriate way the calibration of the test equipment items
C — Notified body
3.4 — The notified body carries out a check of the quality system to establish whether the latter meets the requirements provided for in nos. 3.2 and 3.3 and assumes the compliance with those requirements, if the system applies the corresponding harmonized standards.
3.4.1 — The auditing team in charge with the assessment should include, at least, one element with due experience and knowledge in the assessment of the concerned technology, and the assessment procedure should include an inspection to the manufacturer’s facilities and in duly justified case, to those of the suppliers and or the manufacturer’s sub-contractors with a view to check the manufacturing processes. After the final visit the decision of the auditing team should be notified to the manufacturer and contain all conclusions of the inspection and a reasoned assessment.
3.5 — The manufacturer should inform the notified body which has approved the quality system of any Project of significant changes of the latter or the variety of covered products, and the notified body should assess the changes and check if the quality system changed accordingly, still meets the requirements mentioned in nos. 3.2 to 3.3, notifying the manufacturer on its decision, with all the conclusions of the inspection and a reasoned assessment.
Part II
Supervision
4 — The purpose of the supervision is to ensure the manufacturer duly complies with the obligations resulting from the approved quality system.
4.1 — The manufacturer should allow the notified body to carry out all necessary inspections and should provide the former with all appropriate information, in particular:
4.1.1 — The documents regarding the quality system;
4.1.2 — All technical documents;
4.1.3 — All data regarding manufacturing in the quality system, such as reports regarding inspections, tests, calibrations and qualifications of involved staff.
4.2 — The notified body should carry out the suitable inspections and assessments so as to certificate that the manufacture applies the approved quality system, and should deliver an assessment report to the manufacturer.
4.3 — The notified body may carry out unannounced visits to the manufacturer, during which, if deemed necessary, it may carry out verification tests of the quality system, or have them carried out, and should hand over to the manufacturer an inspection report and a report of the tests carried out.
Part III
Administrative provisions
5 — The manufacturer or his authorized representative must, for a period ending at least five years, and 15 years in the case of implantable devices, after the last product has been manufactured, make available to the national authorities:
5.1 — The declaration of conformity.
5.2 — The documents mentioned in no. 3.1.4.
5.3 — The changes mentioned in no. 3.5.
5.4 — The documents mentioned in no. 3.1.7.
5.5 — The decisions and reports of the notified body mentioned in nos. 4.2 and 4.3.
5.6 — And where appropriate, the EC type- examination certificate referred to in annex III.
Parte IV
Application to devices in class IIa
6 — This annex applies to products of classes IIa, according to the provisions of subparagraph c) of no. 1 of article 8 of decree-law of which this annex is an integral part, with the following limitations:
6.1 — In derogation nos. 2, 3.1, 3.2 and 3.3 by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in no. 3 of annex VII and meet the requirements of this decree-law which apply to them
6.2 — In the case of devices of class IIa, the notified body assesses, as part of the assessment laid out on no 3.4, the technical documents described in no 3 of attachment VII regarding, at least, a representative sample of each subcategory of the device, the respective conformity with the provisions of this decree-law.
6.3 — When choosing the representative sample or samples, the notified body takes into consideration the new technology, the similarities of the design, technology and methods of manufacture and sterilization, the purpose and the results of any previous relevant assessments (namely on the physical, chemical or biological properties) that have been carried out in compliance with this decree-law, and should keep at the disposal of the competent authority the analysis of the chosen samples.
6.4 — The no t i f ied b od y carries ou t the assessmen t of o ther samples in the scope of the supervision mentioned in no. 4.2.
Part V
Application to devices which incorporate a substance derived from human blood according to subparagraph b) of no. 2 of article 2
7 — Once concluded the manufacture process of each batch of the device of the type mentioned in subparagraph b) of no. 2 of article 2 of the decree- law, of which this annex is an integral part, the manufacturer informs the notified body on the validation of this batch, sending him the official validation certificate of the batch of the substance derived from human blood used in that device, prepared and drawn up by the laboratory appointed according to the provisions of no. 2 of article 114 of Directive no. 2001/83/CE, of the European Parliament and the Council, of 6 November (article 135, no. 4, of Decree-Law no. 176/2006 of 30 August).
ANNEX VI
[mentioned in sub-subparagraph ii) of subparagraph b) of no. 1 of article 8]
EC declaration of conformity
Quality guarantee of the products
1 — The manufacturer should make sure the quality system approved for final inspection and tests of the products is applied, according to the provisions of no. 3, being subject to EC supervision provided for in no. 4. For products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer should apply the provisions of nos. 3 and 4 of annex V.
2 — The EC declaration of conformity is the procedure through which the manufacturer which com plies with the requirements of no.1, states and guarantees that the concerned devices are in conformity with the type described in the C-type examination certificate and the provisions of this decree-law which apply to them.
2.1 — The manufacturer should affix the EC marking according to article 7 of decree-law of which this annex is an integral part and prepare a declaration of conformity, in writing, which should cover one or more devices clearly identified by the name of the product, the code of the product or another unequivocal reference, and to be kept by the manufacturer
2.2 — The EC marking is comes with the identification number of the notified body performing the tasks mentioned in this annex.
Part I
Quality system
A — Assessment request
3 — The manufacturer should submit an assessment request of its quality system to the notified body.
3.1 — The above mentioned request should include:
3.1.1 — The manufacturer’s name and address and any other manufacturing places covered by the quality system;
3.1.2 - All information regarding the products and product categories the process applies to;
3.1.3 — A written declaration stating that an equivalent application has not been submitted to any other notified body with respect to the same quality system;
3.1.4 - The documents regarding the quality system;
3.1.5 - The manufacturer’s commitment to comply with the obligations resulting from the approved quality system;
3.1.6 — The manufacturer’s commitment to keep the approved quality system suitable and updated;
3.1.7 — Possibly the technical documents regarding the approved types and a copy of the EC-type examination certificates;
3.1.8 — The manufacturer’s commitment to create and update a process of systematic analysis of the experience acquired with the devices in post-production stage, including the provisions mentioned in annex XVI, and to develop suitable means to implement any required corrections, a commitment which includes the obligation of the manufacturer to inform the competent authorities on the incidents mentioned in article 27 of this decree-law, as soon as it becomes aware of them.
3.2 — In the scope of the quality system, each of the products or a representative sample of each batch should be reviewed and suitable tests mentioned in article 6 should be carried out or equivalent tests must be carried out in order to verify, where appropriate, the conformity of the products with the EC type described in the EC type-examination certificate and with the requirements of the decree-law which apply to them.
B — Documents
3.3 — All details, requirements and provisions adopted by the manufacturer should be included in the documents organized in a systematic and ordered manner as written measures, procedures and instructions, and these documents should enable an uniform interpretation of programs, plans, manuals, and quality records.
3.4 — The documents mentioned in the previous number should, in particular, describe suitably:
3.4.1 — The quality objectives and the organization chart, the staffs’ responsibilities and their skills in the field of the products’ quality;
3.4.2 — The controls and tests carried out after the manufacturing, calibration of tests equipment being carried out so as to enable a suitable control;
3.4.3 — The means to control the quality system efficient operation;
3.4.4 — Quality records, such as inspection, tests, calibrations reports and the qualification records of the involved staff;
3.4.5 — In case the final inspection and tests of the products or their elements are carried out by third parties, the control methods of the efficient operation of the quality system, especially, the type and scope of the control applied to those third parties.
3.5.The checks mentioned in no. 3.2 do not apply to the aspects of the manufacture pursuant to sterilization.
C — Notified body
3.6 — The notified body carries out a check of the quality system to establish whether the latter meets the requirements provided for in nos. 3.2, 3.3 and 3.4 assumes the compliance with those requirements, if the quality system applies the corresponding harmonized standards.
3.7 — The auditing team in charge with the assessment should include, at least, one element with due experience and knowledge in the assessment of the concerned technology, and the assessment procedure should include A visti to the manufacturer’s facilities and, in duly justified cases the facilities of the manufacturer’s suppliers or sub- contractors with a view to control the manufacture processes.
3.8 — The decision should be notified to the manufacturer including the conclusions of the inspection and a reasoned assessment.
3.9 — The manufacturer should inform the notified body which has approved the quality system of any project of significant changes of the latter or the variety of covered products, and the notified body should assess the changes and check if the quality system changed accordingly, still meets the requirements mentioned in nos. 3.2 and 3.3, notifying the manufacturer on its decision, with all the conclusions of the inspection and a reasoned assessment.
Part II
Supervision
4 — The purpose of the supervision is to ensure that the manufacturer complies correctly with the obligations resulting from the approved quality system.
4.1 — The manufacturer should authorize the notified body to carry out all necessary inspections and provide it with suitable information, especially:
4.1.1 — The documents regarding the quality system;
4.1.2 — Quality system data regarding the manufacture, such as inspection reports and trial data, calibration data, quality reports of the involved staff, etc.;
4.1.3 — All technical documents.
4.2 — The notified body should carry out periodical suitable inspections and assessments so as to certificate that the manufacture applies the approved quality system, and should deliver an assessment report to the manufacturer.
4.3 — In addition to what was mentioned in no. 4.2, the notified body may carry out unannounced visits to the manufacturer, during which, if deemed necessary, it may carry out verification tests of the quality system and the compliance of the production with the requirements of this decree-law or have them carried out, checking a suitable sample of the finished products collected on site by the notified body according to the provisions mentioned in article 6 of the decree-law of which this annex is an integral part, or equivalent tests, the notified body taking the suitable measures in case one or more specimen of the products are not compliant.
4.4 — The notified body should give to the manufacturer a report on the visit and, if appropriate, a test report.
Part III
Administrative provisions
5 — The manufacturer or his authorized representative must, for a period ending at least five years, and 15 years in the case of implantable devices, after the last product has been manufactured, make available to the national authorities:
5.1 — The declaration of conformity.
5.2 — The documents mentioned in no 3.1.7.
5.3 — The changes mentioned in no. 3.9.
5.4 — The decisions and reports of the notified body mentioned in nos. 3.9, 4.2 and 4.4.
5.5 — If appropriate, the EC type-examination certificate provided for in annex III.
Part IV
Application to devices in class IIa
6 — This annex applies to products in classes IIa, according to the provisions of subparagraph c) of no. 1 of article 8 of decree-law of which this annex is an integral part, with the following limitations:
6.1 — In derogation nos. 2 to 3.5, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in class lIa are manufactured in conformity with the technical documents referred to in no. 3 of annex VII and meet the requirements of this decree-law which apply to them.
6.2 — In the case of devices of class IIa, the notified body assesses, as part of the assessment laid out in no 3.6, the technical documents described in no 3 of attachment VII regarding, at least, a representative sample of each subcategory of the device, the respective conformity with the provisions of this decree-law.
6.3 — When choosing the representative sample or samples, the notified body takes into consideration the new technology, the similarities of the design, technology and methods of manufacture and sterilization, the purpose and the results of any previous relevant assessments (namely on the physical, chemical or biological properties) that have been carried out in compliance with this directive, and should document and keep at the disposal of the supervisory authorities the analysis of the chosen samples.
6.4 — The notified body carries out the assessmen t of o ther samp les in the scope o f the sup ervisio n mentioned in n o.4. 2 .
ANNEX VII
[mentioned in sub-subparagraph ii) of subparagraph c) of no. 1 of article 8]
EC declaration of conformity
1 — The EC declaration of conformity is the procedure through which the manufacturer which com plies with the requirements of no. 2, as well as in what concerns products placed on the market in a sterile condition and measuring devices, the obligations laid down in no. 5, states and guarantees that the concerned devices are in conformity with the provisions of this decree-law which apply to them.
2 — The manufacturer prepares the technical documents mentioned in no. 3, and he or his authorized representative should keep the mentioned documents, including the declaration of conformity at the disposal of the competent authority for, at least, five years or, in the case of implantable devices, 15 years after the last product was manufactured.
3 — The technical documents should enable to assess the conformity of the products with the requirements of this decree-law and cover, namely:
3.1 — A general description of the product, including the possible alternatives, as well as their purposes;
3.2 — The design drawings and description of manufacture methods, as well as the scheme of components, subsets, circuits, etc.;
3.3 — The necessary descriptions and explanations for the comprehension of the mentioned drawings and diagrams and the operation of the device;
3.4 — The results of the risk analysis as well as a list of the standards mentioned in article 6.º of the decree-law of which this annex is an integral part, fully or partially applied, and the description of the adopted solutions to meet the essential requirements of this decree-law, in case the mentioned standards are not entirely applied;
3.5 — As for products placed on the market in a sterile condition, the description of the adopted methods and the validation report;
3.6 — The results of the design calculations, the inspections carried out, etc., and the checking that when a device should be connected to others to be able to be operated according to the respective purpose, the mentioned device meets the essential requirements when connected to a device or devices of the concerned type according to the features indicated by the manufacturer;
3.7 — The adopted solutions such as they are mentioned in no. 2 of annex I;
3.8 — The pre-clinical assessment;
3.9 — The clinical assessment in compliance with annex
XVI;
3.10 — The label and the instructions for use.
4 — The manufacturer’s commitment to create and update a process of systematic analysis of the experience acquired with the devices in post-production stage, including the provisions mentioned in annex XVI, and to develop suitable means to implement any required corrections, taking into account the nature and risks regarding the device, a commitment which includes the obligation of the manufacturer to inform the competent authorities on the incidents mentioned in article 27 of this decree-law, as soon as it becomes aware of them.
5 — As for the products placed on the market in a sterile condition and devices in class I with measuring purposes, the manufacturer should apply, in addition to the provisions of this annex, one of the procedures mentioned in annex II, IV, V or VI of this decree-law. The application of the mentioned annexes and the intervention of the notified body should be limited to:
5.1 — As for the products placed on the market in a sterile condition, only to the aspects of the manufacture concerned with securing and maintaining the sterile condition;
5.2 — As for devices with measuring purposes, only the aspects of manufacturing regarding the conformity of the products with metrological requirements;
5.3 — No. 6.1 of this annex applies.
6 — This Annex may apply to products in class lIa, according to subparagraph c) of no. 1 of article 8 of the decree-law of which this annex is an integral part subject to the following derogation:
6.1 — Where this annex is applied in conjunction with the procedure referred to in Annex IV, V or VI of this decree-law, the declaration of conformity referred to in the abovementioned Annexes forms a single declaration. As regards the declaration based on this Annex, the manufacturer must ensure and declare that the product design meets the provisions of this decree-law which apply to it.
ANNEX VIII
(mentioned in no. 4 of article 5)
Declaration regarding devices for specific purposes
1 — The manufacturer, or its authorized representative should prepare, with regards to customized devices or devices intended for clinical researches a declaration.
2 — The declaration comprises the following information:
2.1 — For customised devices:
2.1.1 — The manufacturer’s name and address;
2.1.2 — Data enabling to identify the concerned device;
2.1.3 — A declaration stating that the device is intended for a specific patient and that patient’s name;
2.1.4 — The name of the physician or authorized technician which has written the concerned prescription and, in some cases, the identification of the medical institution;
2.1.5 — The specific characteristics of the device such as indicated in the medical prescription;
2.1.6 — The declaration that the device is in conformity with essential requirements mentioned in annex I and, if appropriate, the indication of the essential requirements which have not been fully complied with, accompanied with the respective justification.
2.2 — For devices intended for clinical researches mentioned in annex XVI:
2.2.1 — Data enabling to identify the concerned device;
2.2.2 — The clinical research plan;
2.2.3 — The investigator’s brochure;
2.2.4 — The confirmation that the involved individuals are covered by insurance;
2.2.5 — The documents used to get the free and informed consent;
2.2.6 — A declaration stating whether or not the device includes, as an integral part a substance which when used separately can be considered as a medicinal product or substance derived from human blood, mentioned in nos. 7.4 and 7.5 of annex I;
2.2.7 — A declaration stating whether or not animal tissues are used to manufacture the device, such as it is mentioned in Directive no. 2003/32/CE, of the Commission of 23 April, and chapter VII of decree-law of which this annex is an integral part;
2.2.8 — The opinion of the competent ethical committee for health;
2.2.9 — The identification of the physician or the authorized research team and the institution or research site in charge with the researches;
2.2.10 — The place where the researches take place, as well as the respective start date and expected duration;
2.2.11 — The declaration that the concerned device is in conformity with the essential requirements,
With the exception of the aspects which are the object of researches, and the guarantee regarding the latter that all precautions have been taken to protect the patient’s health and safety.
3 — The manufacturer undertakes to keep at the disposal of the competent authority:
3.1 — As to customised devices, all documents indicating the manufacturing place or places
and enable to understand the design, manufacture and performance of the product, including the expected operation level, so as to make it possible to assess its conformity with the requirements of this decree-law;
3.1.1 — The manufacturer take all necessary measures for the manufacturing process to ensure the conformity of the manufactured products with the documents mentioned in
no. 3.1;
3.2 — In the case of devices intended for clinical researches, the documents should include the following details:
3.2.1 — A general description device, as well as its purposes;
3.2.2 — The design drawings and description of manufacture methods, namely in terms of sterilization, as well as diagrams and scheme of components, subsets, circuits;
3.2.3 — The necessary descriptions and explanations for the comprehension of the mentioned drawings and diagrams and schemes, mentioned in the previous number, as to the operation of the device;
3.2.4 — The results of the risk analysis as well as a list of the standards mentioned in article 6 of the decree-law of which this annex is an integral part, fully or partially applied, and the description of the adopted solutions to meet the essential requirements of this decree-law, in case the mentioned standards are not entirely applied;
3.2.5 — If the device includes, as an integral part, a substance or a substance derived from human blood, mentioned in nos. 7.4 and 7.5 of annex I, the data regarding the tests carried out for that purpose and which are necessary to assess the safety, quality and usefulness of that substance or substance derived from human blood, taking into account the purpose of the device;
3.2.6 — Whether or not animal tissues are used in the manufacture of the device, such as they are mentioned in Directive no. 2003/32/CE, of the Commission of 23 April, and chapter VII of decree-law of which this annex is an integral part, as well as the measures of risk management adopted to reduce the infection risk;
3.2.7 — The results of the design calculations, the inspections carried out, etc.;
3.2.8 — The manufacturer takes the necessary measures for the manufacture process ensures the conformity of the manufactured products with the documents mentioned in no. 3.1;
3.2.9 — The manufacturer authorizes the assessment or, if appropriate, the checking of the efficiency of those measures by means of an audit.
4 — Information included in declarations mentioned n this annex should be kept during, at least, 5 years or, in the case of implantable devices 15 years.
5 — Regarding customized devices the manufacturer’s commitment to create and update a process of systematic analysis of the experience acquired with the devices in post-production stage, including the provisions mentioned in annex XVI, and to develop suitable means to implement any required corrections, a commitment which includes the obligation of the manufacturer to inform the competent authorities on the incidents mentioned in article 27 of this decree-law, as soon as it becomes aware of them.
ANNEX IX
(mentioned in no. 1 of article 4.)
Classification criteria
Group I
Definitions
Part I Classification rules
1 — Definitions regarding classification rules:
1.1 — As to the duration, devices may be:
1.1.1 — Temporary, when normally intended to be used continuously for a period less than 60 minutes;
1.1.2 — Of short term, when they are normally intended to be used continuously for a period not greater than
30 days;
1.1.3 — Of long term, when they are normally intended to be used continuously for a period greater than 30 days.
1.2 — As to invasive devices:
1.2.1 — Invasive device — the device which penetrates partially or fully the body by one of its orifices, or crossing its surface;
1.2.2 — Body orifice — any natural opening of the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as, for example, a stoma;
1.2.3 — Surgically invasive device — the invasive device which penetrates the body by means of a surgical intervention or in the context of a surgical intervention;
1.2.4 — For the purposes of this decree-law the devices which are not mentioned in the previous number and do not penetrate the body through a permanent orifice are dealt with as invasive devices of surgical type.
1.3 — Implantable devices are the ones intended to be fully introduced in the human body, or to replace an epithelial surface or the eye surface by means of a surgical intervention and which are intended to be kept in place after the intervention.
1.4 — It is also considered an implantable device the any device intended to be partially introduced in the human body by means of a surgical intervention and to be kept in place, after the intervention, for a period not less than 30 days.
1.5 — Reusable surgical instrument — the instrument intended to cut, section, perforate, saw, scrape, remove, staple, retract, or a similar process, in the scope of surgical interventions, without being connected to any active medical device, and which can be reused after suitable treatment.
1.6 — Active medical device — medical device defined in subparagraph v) of article 3 of decree-law of which this annex is an integral part, the software, on its own being considered an active medical device.
1.7 — Active device of therapeutic nature — the active medical device used separately or together with other devices to keep, change, replace or re-establish biological functions or structures in the scope of a treatment or mitigation of a disease, lesion or impairment.
1.8 — Active medical device for diagnosis — the active medical device used, separately or together with other medical devices, to provide information with a view to the detection, diagnosis, control or treatment of physiological status or health status, diseases or congenital malformation.
1.9 — In the scope of this decree-law, it is understood as central circulatory system the vessels pulmonary artery, ascending aorta, arch of the aorta descending aorta, descending aorta until the aortal bifurcation, coronary arteries, common carotid artery, external carotid artery, internal carotid artery, cerebral arteries, brachiocephalic trunk, venae cordis, pulmonary veins, superior vena cava and inferior vena cava.
1.10 — In the scope of this decree-law, it is as central nervous system the brain, the meninxes and the spinal cord.
Group II
Rules of application
2 —The application of classification rules is governed by the purpose of the devices.
2.1 — In case the device is intended to be used together with another device, the classification rules apply to each one of the devices separately, the accessories being classified on their own separately from the devices they are used with.
2.2 — The software controlling a device or which influence its use pertain automatically to the same category as that device.
2.3 — In case the device is not intended to be used in a one and only specific part of the human body, it should be classified based on its more critical specific use.
2.4 — In case several rules apply to a same device taking into account, the operation level specified by the manufacturer, stricter rules should be applied leading to the classification into the highest class.
2.5 — In the calculation of duration mentioned in no. 1.1 of group I, a continuous use means an uninterrupted real use of the device for the intended purpose, but every time the use of the device is discontinued to replace it immediately with the same device or a similar one, it is considered that as being an extension of the continuous use of the device.
Group III Classification Part I
Non invasive devices
3 — The classification rules of the non invasive devices are the following:
Rule no. 1
3.1 — All non invasive devices belong to class I, except in the case one of the following rules apply.
Rule no. 2
3.2 — All non invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of infusion, administration or introduction in the body are in class IIa:
3.2.1 — In case they may be connected to an active medical device in class IIa or a higher class;
3.2.2 — In case they are intended for use of storing or channelling of blood or other body liquids or for storing organs, parts of organs or body tissues;
3.2.3 — In all other cases, the devices pertain to class I.
Rule no. 3
3.3 — All non-invasive devices intended for modifying the biological or chemical composition of the blood, or other body liquids or other liquids intended for infusion are in class IIb, unless the treatment consists of filtration, centrifuging or exchanges of gas and heat, in which case they are in class IIa.
Regra n.º 4
3.4 — All non-invasive devices that come in touch with injured skin:
3.4.1 — Are in class I, if they are intended to be used as a mechanical barrier for compression of absorption of exudates;
3.4.2 — Are in class IIb, in case they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent ;
3.4.3 — Are in class IIa in all other cases, including devices principally intended to manage the microenvironment of a wound.
Part II Invasive devices
4 — The classification rules for invasive devices are the following:
Rule no. 5
4.1 — All invasive devices with respect to body orifices, other than those which are surgically invasive, and which are not intended for connection with an active medical device of class I:
4.1.1 — Are in class I, if they are intended for transient use;
4.1.2 — Are in class IIa, if they are intended for short-term use, unless they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or a nasal cavity, in which case they are in class I;
4.1.3 — Are in class IIb, if they are intended for long-term use, unless they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or a nasal cavity and if they are not liable to be absorbed by the mucous membrane, in which cases they are in class IIa;
4.1.4 — All invasive devices with the respect to body orifices, other than those which are surgically invasive that are intended to be connected to an active medical device in class IIa, or a higher class, are in class IIa.
Rule no. 6
4.2 — All surgically invasive devices intended for transient use are in class IIa, unless:
4.2.1 — They are intended specifically to control, diagnose, monitor or correct cardiac defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which cases they are in class III;
4.2.2 — They are reusable surgical instruments in which case they are in class I;
4.2.3 — They are intended to be used in direct contact with the central nervous system, in which case they are in
class III;
4.2.4 — They are intended to supply energy in the form of ionizing radiation, in which case they are in class IIb;
4.2.5 — They are intended to have a biological effect or to be wholly or mainly absorbed, in which case they are in class IIb;
4.2.6 — They are intended to administer medicinal products by means of a delivery system, if this is done in a manner that is potentially hazardous taking into account the mode of application, in which case they are in class IIb.
Rule no.º 7
4.3 — Al surgically invasive devices to be used in the short- term are in class IIa, unless they are intended fror:
4.3.1 — They are specifically intended to control, diagnose, monitor or correct cardiac defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which cases they are in class III;
4.3.2 — They are intended to be used in direct contact with the central nervous system, in which case they are in
class III;
4.3.3 — They are intended to supply energy in the form of ionizing radiation, in which case they are in class IIb;
4.3.4 — They are intended to have a biological effect or to be wholly or mainly absorbed, in which case they are in class III;
4.3.5 — They are intended to undergo chemical change in the body, unless if the devices are placed in the teeth, or administer medicinal products, in which case they are in class IIb.
Rule no. 8
4.4 — All implantable devices and long-term surgically invasive devices are in class IIb, unless they are intended:
4.4.1 — To be placed in the teeth, in which case they are in class IIa;
4.4.2 — To be used in direct contact with the heart, the central circulatory system or central nervous system, in which cases they are in class III;
4.4.3 — To have a biological effect or to be wholly or mainly absorbed, in which case they are in class III;
4.4.4 — They are intended to undergo chemical change in the body, unless if the devices are placed in the teeth, or administer medicinal products, in which case they are in class
III.
Part III
Complementary Rules applying to active devices
5 — The complementary rules applying to active devices are the following:
Rule no. 9
5.1 — All active therapeutic devices intended to administer or Exchange energy are in class IIa, unless:
5.1.1 — Their characteristics are such that they may administer or Exchange energy to or from the human body , in a potentially hazardous way, including ionizing radiation, taking into account the nature, the density and site of application of the energy, in which cases they are in class IIb;
5.1.2 — All active devices intended to control or monitor the performance of active therapeutic devices in class IIb, or intended directly to influence the performance of such devices, are in class IIb.
Rule n.º 10
5.2 — Active devices intended for diagnosis are in class IIa:
5.2.1 — If they are intended to supply energy which will be absorbed by the human body, except for devices used solely to illuminate the patient’s body with light in the visible spectrum;
5.2.2 — If they are intended to image in vivo the distribution of radiopharmaceuticals;
5.2.3 — If they are intended to enable the direct diagnosis or monitoring physiological parameters where the nature of the variations is such that it could result in immediate danger for the patient, for instance variations of in cardiac performance, respiration, activity of central nervous system (CNS), case when they are in class IIb;
5.2.4 — Active devices intended to emit ionizing radiation and intended for diagnostic and/or interventional radiology including devices which control or monitor such devices, or those which directly influence their performance are in class IIb.
Rule no.º 11
5.3 — All devices intended to administer and/or remove medicines, body liquids or other substances to or from the human body are in class IIa, unless this is done in a manner that is potentially hazardous, taking into account the nature of the substances involved and the part of the body concerned as well as the mode of application, in which case they are in class IIb.
Rule no. 12
5.4 — All other devices are in class I.
Part IV
Special Rules
6 — The special rules are those included in the following numbers:
Rule no. 13
6.1 — All devices incorporating, as an integral part, a substance, if used separately, can be considered to be a medicinal product, according to the legal system of medicinal products for human use and which is liable to act on the human body with action ancillary to that of the devices are in class III; all devices incorporating as an integral part, a substance derived from the human blood are also in this class.
Rule no 14
6.2 — All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are class IIb, unless they are implantable or long-term invasive devices, in which case they are in class III.
Rule no. 15
6.3 — All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate hydrating contact lenses
are in class IIb and all devices intended specifically for disinfecting medical devices are in class IIa, unless they are specifically intended to disinfecting invasive devices, in which case they are in class IIb.
6.3.1 — This rule does not apply to products intended to clean medical devices other than contact lenses by means of physical action.
Rule no. 16
6.4 — The devices specifically intended to keep records of diagnosis radiographic images are in class IIa.
Rule no. 17
6.5 — All devices which are manufactured from or incorporate non-viable animal tissues or their derivatives are in class III, unless those devices are intended to come in contact with intact skin only.
Rule no. 18
7 — In derogation of the provisions of the other rules, blood bags are in class IIb.
ANNEX X
[mentioned in subparagraph a) of no. 1 of article 5]
I — General requirements
General requirements
1 — The active medical devices, hereinafter referred to as devices, must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients, nor the safety or the health of the users or third parties.
2 — The devices must achieve the performances intended by the manufacturer, viz. be designed and manufactured in such a way that they are suitable for one or more of the functions referred to in subparagraph u) of article 3 of the decree-law, of which this annex is an integral part as specified by him.
3 — The characteristics and performances referred to in nos. 1 and 2 must not be adversely affected to such a degree that the clinical condition and safety of the patients or, as appropriate, of other persons are compromised during the lifetime of the device anticipated by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.
4 — The devices must be designed, manufactured and packed in such a way that their characteristics and performances are not adversely affected in the storage and transport conditions laid down by the manufacturer such as temperature, humidity, etc.
5 — Any side effects or undesirable conditions must constitute acceptable risks when weighed against the performances intended.
6 — Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with annex XVI.
II — Requirements regarding design and manufacture
7 — The solutions adopted by the manufacturer for the design and construction of the devices must comply with safety principles taking account of the generally acknowledged state of the art.
8 — Implantable devices must be designed, manufactured and packed in a non-reusable pack according to appropriate procedures to ensure they are sterile when placed on the market and, in the storage and transport conditions stipulated by the manufacturer, remain so until the packaging is removed and they are implanted.
9 — Devices must be designed and manufactured in such a way as to remove or minimize as far as possible:
a) the risk of physical injury in connection with their physical, including dimensional, features;
b) risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices;
c) risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure and acceleration;
d) risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment;
e) risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Decree-laws nos. 165/2002 of 17 July and 167/2002 of 18 July laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation and on health protection of individuals against danger of ionizing radiation in relation to radiological exposure;
f) risks which may arise where maintenance and calibration are impossible, including excessive increase of leakage currents, ageing of the materials used, excess heat generated by the device, decreased accuracy of any measuring or control mechanism.
10 — The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in nos. 1 to 6., with particular attention being paid to:
a) the choice of materials used, particularly as regards toxicity aspects;
b) mutual compatibility between the materials used and biological tissues, cells and body fluids, account being taken of the intended use of the device;
c) compatibility of the devices with the substances they are intended to administer;
d) The quality of the connections, particularly in respect of safety;
e) the reliability of the source of energy;
f) if appropriate, that they are leak proof;
g) proper functioning of the programming and control systems, including software. For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development, lifecycle, risk management, validation and verification.
11 — Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in legal system of medicinal products of human use, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC of the European Parliament and the Council of 6 November (Decree-Law no. 176/2006, of 30 August).
11.1 — For the substances referred to in no. 11, the notified body
shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities in the scope of Directive no. 2001/83/EC of the European Parliament and the Council of 6 November designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004 (2) on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device.
11.2 — When issuing its opinion, mentioned in the previous number the competent authority, or the EMEA, shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.
12 — Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device.
.
12.1 — When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.
13 — Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.
13.1 — When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with opinion, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.
14 — The devices and, if appropriate, their component parts must be identified to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices and their component parts.
15 — Devices must bear a code by which they and their manufacturer can be unequivocally identified, particularly with regard to the type of device and year of manufacture the identification of the manufacturer; it must be possible to read this code, if necessary, without the need for a surgical operation.
16 — When a device or its accessories bear instructions required for the operation of the device or indicate operating or adjustment parameters, by means of a visual system, such information must be understandable to the user and, as appropriate, the patient..
17 — Every device must bear, legibly and indelibly, the following particulars, where appropriate in the form of generally recognized symbols:
17.1 — On the sterile pack:
a) the method of sterilization,, and the words «Sterile»;
b) an indication permitting this packaging to be recognized as such;
c) The name and address of the manufacturer;
d) A description of the device;
e) if the device is intended for clinical investigations, the words: «Exclusively for clinical investigations»;
f) If the device is custom-made, the words «custom- made device»;
g) the month and year of manufacture;
h) an indication of the time limit for implanting a device safely.
17.2 — On the sales packaging:
a) The manufacturer’s name and address and the name and address of the authorized representative of the manufacturer when the latter does not have a registered office within the European Union;
b) A description of the device;
c) The purpose it is intended for;
d) The pertinent characteristics for its use;
e) If the device is intended for clinical investigations, the words: «Exclusively for clinical investigations»;
f) The words «Customized device», when appropriate;
g) The words «Sterile»;
h) The month and year of manufacture;
i) An indication of the time limit for implanting a device safely;
j) The transport and storage conditions;
l) The words stating that the device includes, as an integral part, a derivative of human blood, for devices provided for in subparagraph b) of no. 2 of article 2 of the decree-law of which this annex is an integral part.
18 — When placed on the market, the devices should be accompanied with instructions for use, including the following particulars:
a) The year of the authorization to affix the EC marking;
b) The indications mentioned in nos. 17.1 and 17.2, except for those in subparagraph g) and h) of no. 17.1 and h) and i) of no. 17.2;
c) The performance mentioned in no. 2, as well as the possible undesirable side effects;
d) The information required by the physician to select the suitable device, as well as the adjusted software and accessories;
e) The information included in the instructions for use and which enable the physician and, if appropriate, the patient a correct use of the device, the respective accessories and the software, as well as the information regarding the nature, scope and deadlines for control and the work tests and, if necessary, the maintenance measures;
f) Any useful information allowing avoiding certain risks regarding is implantation;
g) Information regarding mutual interference risks, such as negative influences on the device caused by instruments present at the moment of the researches or treatments, and vice-versa, which may be associated with the presence of the device during specific researches or treatments;
h) Instructions necessary in case the package ensuring sterility is damaged and, if necessary, the indication of the suitable methods to carry out a new sterilization;
i) The warning, if appropriate, that the device cannot be used more than once, unless it has been packaged once again under the responsibility of the manufacturer to be in compliance with the essential requirements.
19 — The instructions for use should also include information enabling the physician to inform the patient on the contraindications and precautions to take, and this information should include in particular:
a) Information to enable establishing the durability of the energy source;
b) Precautions to be taken in case of changes in the operation of the device;
c) The precautions to take with respect to the exposure, in reasonably predictable environmental conditions to magnetic fields, the external electrical influences, electrical discharges, the pressure or the pressure variations and acceleration;
d) Suitable information on medicinal products which the concerned device is intended to administer;
e) The manufacturing date or the last review of the instructions for use.
20 — The check of the conformity with requirements regarding the characteristics and performance of the device mentioned in nos. 1 to 6, in normal operation conditions, as well as the assessment of undesirable or side effects, should be carried out based in the clinical data mentioned in annex XVI.
21 — The indications which have to be provided to the user and the patient, according to nos. 17, 18 and 19 should be written in Portuguese, in a legible and indelible manner, at the time they are provided to the final user, irrespective of whether they are intended or not to some professional use, notwithstanding the possibility of being drawn up in other languages.
ANNEX XI
[mentioned in subparagraph a) of no. 2 of article 8]
EC Declaration of Conformity
Full system of quality guarantee
1 — The manufacturer should apply the approved quality assurance system approved for the design, manufacturing and final control of the concerned products, such as it is specified in parts I and II being subject to EC checking provided for in part III.
2 — The declaration of conformity is the procedure through which the manufacturer which com plies with the requirements provided for in the previous number, states and guarantees that the concerned devices are compliant with the applicable provisions of decree-law of which this annex is an integral part.
2.1 — The manufacturer should affix the EC marking according to article 7 of decree-law of which this annex is an integral part and prepare a declaration of conformity, in writing, which should cover one or more devices clearly identified by the name of the product, the code of the product or another unequivocal reference, and to be kept by the manufacturer..
2.2 — The EC marking should be accompanied by the identification number ascribed to the body in charge with the conformity assessment.
The above mentioned request should include:
a) The suitable information for the category of devices provided for;
b) The documents regarding quality system;
c) The commitment to comply with all the obligations resulting from the approved quality system;
d) The commitment to keep the approved quality system suitable and efficient;
e) The commitment to create post-sale surveillance system and keep it updated a commitment which includes the obligation of the manufacturer to inform the competent authorities on the incidents mentioned in article 27 of this decree-law, as soon as it becomes aware of them.
4 — The application of the quality system should guarantee the conformity of the products with the provisions of this decree-law which apply to them at all stages, from design to final controls.
B — Documents
5 — All particulars, requirements and provisions adopted by the manufacturer regarding its quality system should be included in documents organized systematically and orderly according to written guidelines and procedures, as, for instance, programs, plans, manuals and quality records, which should enable an uniform interpretation of the policies and procedures in terms of quality and include, in particular, documents, data and records resulting from the procedures mentioned in subparagraph c) of the following number.
6 — The documents mentioned in the previous number should, in particular, describe suitably:
a) The manufacturer’s quality objectives;
b) The company’s organization and in particular:
i) The organizational structures, the responsibilities of the staff their organizational skills in terms of the quality of the design and manufacture of the products;
ii) — The methods enabling to control the efficient operation of the quality system, and namely its capacity to achieve the requested quality in what concerns the design and manufacture of the products, including the control of the non compliant products;
iii) — If the design, the manufacture and, or the inspection and final tests of the products and their components are carried out by third parties, the control methods of the efficient operation of the quality system, especially, the type and scope of the control applied to those third parties;
Part I
Quality system
A — Assessment application
3 — The manufacturer should submit a request for the assessment of its quality system to a notified body.
c) The procedures intended for the control and check the design of the products in particular:
i) The specification of the design, including the standards which are applied and the results of the risk analysis, as well as the description of the adopted solutions to meet the essential requirements which apply to the products, whenever the standards mentioned in article 6 of the decree-law, of which this annex is an integral part do not apply integrally;
ii) The control and checking techniques of the design and procedures and the measures which are systematically used for the design of the products;
iii) A declaration stating whether the device includes or not, as an integral part, a substance or a derivative from human blood mentioned in nos. 11 and 12 of annex X, as well as data regarding the tests carried out for that purpose and which are necessary to assess the safety, quality and usefulness of that substance or substance derived from human blood, taking into account the purpose of the device;
iv) The pre-clinical assessment;
v) The clinical assessment mentioned in Xxxxx XXX;
d) Control and guarantee techniques of the quality as for manufacture and in particular:
i) The processes and procedures used, in particular in terms of sterilization, purchases and procedures and relevant documents;
ii) The identification procedures of the product established and updated from drawings, specifications or other documents relevant for all stages of the manufacturing process;
e) checks and suitable tests carried out before, during and after the manufacture, the frequency as the former are carried out and the test equipment used ensuring in an appropriate way the calibration of the test equipment items.
C — Notified body
7 — The notified body carries out a check of the quality system to establish whether the latter meets the requirements provided for in nos. 4, 5 and 6 and assumes the compliance with those requirements, if the system applies the corresponding harmonized standards..
7.1 — The auditing team in charge with the assessment should include, at least, one element with due experience and knowledge in the assessment of the concerned technology, and the assessment procedure should include: An inspection to the manufacturer’s facilities and, in duly justified cases, to those of the suppliers and or the sub-contractors, with the aim to inspect the manufacturing procedures.
7.2 — The decision should be notified to the manufacturer and should include the conclusions of he inspection and a reasoned assessment.
8 — The manufacturer should inform the notified body which has approved the quality system of any Project of significant changes of the latter or the variety of covered products, and the notified body should assess the changes and check if the quality system changed accordingly, still meets the requirements mentioned in nos. 4, 5 and 6, notifying the manufacturer on its decision, with all the conclusions of the inspection and a reasoned assessment.
Part II
Examination of the design of the product
9 — In addition to the obligations incumbent on him under nos. 3 to 8, the manufacturer shall make an application for examination of the design dossier relating to any device which he plans to manufacture and which falls into the category referred to in 3.1.
10 — The application shall describe the design, manufacture and performance of the concerned device and it must include the documents needed to assess whether the product conforms to the requirements of this Decree-law, and in particular subparagraphs c) and d) of no. 6.
10.1 — It shall include:
a) the design specifications, including the standards which have been applied;
b) the necessary proof of their appropriations, in particular where the standards referred to in article 6 of the decree-law of which this annex is an integral part have not been applied in full. This proof must include the results of the appropriate tests carried out by the manufacturer or carried out under his responsibility;
c) A statement as to whether or not the device incorporates, as an integral part, a substance as referred to in nos. 11 and 12 of annex x, whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted for that purpose;
d) the clinical evaluation referred to in annex XVI;
e) the draft instruction leaflet and labelling.
11 — The notified body shall examine the application and, where the product complies with the relevant provisions of this Directive, shall issue the applicant with an EC design examination certificate.
11.1 — The notified body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Directive may be evaluated.
11.2 — The certificate shall contain the conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.
12 — In the case of devices referred to in no. 11 of annex x, the notified body shall, as regards the aspects referred to in that number, consult one of the competent authorities appointed by the Member States in accordance with Directive 2001/83/EC of the European Parliament or the EMEA before making a decision.
12.1 — The opinion of the competent national authority or the EMEA, mentioned in the previous number, shall be drawn up within 210 days after receipt of valid documentation.
12.2 — The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device.
12.3 — The notified body will give due consideration to the views expressed in this consultation when making its decision.
12.4 — It will convey its final decision to the competent body concerned.
13 — In the case of devices mentioned in no. 12 of annex X, the scientific opinion of EMEA shall be included in the documents concerning the device.
13.1 — The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation.
13.2 — The notified body will give due consideration the views of EMEA in this consultation when making its decision.
13.3 — The notified body may not issue its opinion if the scientific opinion of EMEA is adverse.
13.4 — The notified body shall convey its final decision to the EMEA.
14 — The applicant shall inform the notified body which issued the EC design examination certificate of any modification made to the approved design. Modifications made to the approved design must obtain supplementary approval from the notified body which issued the EC design examination certificate where such modifications may affect conformity with the essential requirements of this decree-law or the conditions prescribed for the use of the product.
14.1 — This supplementary approval shall be given in the form of an addendum to the EC design examination certificate.
Part III
Surveillance
15 — The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality system.
16 — The manufacturer shall authorize the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:
a) the quality-system documentation;
b) the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted such as mentioned in no. 7 of annex x, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if appropriate, etc..
c) the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardizations/calibrations and reports on the qualifications of the staff concerned, etc.
17 — The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.
18 — In addition, the notified body may make unannounced visits to the manufacturer, during which he may carry out tests to check the good operation of the quality system, or have them carried out, and shall supply him with a report of the inspection and the tests carried out.
Part IV
Administrative provisions
19 — For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:
a) the declaration of conformity;
b) the documentation referred to in subparagraph b) of no. 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2;
c) the amendments referred to in no. 8;
d) the documentation mentioned in no. 10;
e) The decisions and reports of the notified body referred to in nos. 8, 11 to 13, 17 and 18.
Part V
Application to devices which incorporate a derivative form human blood according to subparagraph b) of no. 2 of article 2.
20 — Upon completing the manufacture of each batch of devices referred to in subparagraph b) of no. 2 of article 2 of decree-law of which this annex is an integral part, the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with no. 2 of Article 114 of Directive no. 2001/83/CE, of the European Parliament and the Council, of 6 November (article 135, no. 4, of Decree-Law n. 176/2006, of 30 August).
ANNEX XII
[mentioned in subparagraph b) of no 2 of article 8]
EC-type examination
1 — EC type-examination is the procedure whereby a notified body observes and certifies that a representative sample of the production envisaged complies with the relevant provisions of this decree-law which applies to it.
Part I
A — Examination application
2 — The application for EC type-examination shall be made by the manufacturer, or by his authorized representative, to a notified body.
2.1 — The application shall include:
a) the name and address of the manufacturer and the name and address of the authorized representative if the application is made by the latter;
b) a written declaration specifying that an application has not been submitted to any other notified body;
c) the documentation described in section 3 needed to allow an evaluation to be made of the conformity of a representative sample of the production in question, hereinafter referred to as ‘type’, with the requirements of this decree-law.
The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary.
B — Documentation
3 — The documentation must make it possible to understand the design, the manufacture and the performances of the product. The documentation shall contain the following items in particular:
a) a general description of the type, including any variants planned, and its intended use(s);
b) design drawings, methods of manufacture envisaged, in particular as regards sterilization, and diagrams of parts, sub-assemblies, circuits, etc;
c) the descriptions and explanations necessary for the understanding of the abovementioned drawings and diagrams and of the operation of he product;
d) a list of the standards referred to in article 6, applied in full or in part, and a description of the solutions adopted to comply with the essential requirements where the standards referred to in Article 5 have not been fully applied;
e) the results of design calculations, risk analysis, investigations and technical tests carried out, etc.;
f) a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in nos. 11 and 12 of annex x and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking into account the intended purpose of the device;
g) The pre-clinical evaluation;
h) The clinical evaluation referred to in annex XVI;
i) The draft instruction leaflet and labelling.
C — Notified body
4 — The notified body should:
4.1 — Examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation; it shall also record all the items which have been designed in accordance with the applicable provisions of the standards referred to in article 6 of decree-law of which this annex is an integral part, as well as the items for which the design is not based on the relevant provisions of the said standards;
4.2 — Carry out or have carried out the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer meet the essential requirements of this decree-law where the standards mentioned in article 6 of the decree-law of which this annex is an integral part have not been applied;
4.3 — Carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied;
4.4 — Agree with the applicant on the place where the necessary inspections and tests will be carried out.
5 — Where the type meets the provisions of this Directive, the notified body shall issue an EC type- examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, the conclusions of the control, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The significant parts of the documentation shall be attached to the certificate and a copy shall be kept by the notified body.
5.1 — In the case of devices referred to in no. 11 of annex x, the notified body shall, as regards the aspects referred to in that number, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament or the Council of 6 November or the EMEA before taking a decision.
5.1.2 — The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation.
5.1.3 — The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device.
5.1.4 — The notified body will give due consideration to the views expressed in this consultation when making its decision.
5.1.5 — The notified body shall convey its final decision to the concerned competent body.
5.2 — In the case of devices mentioned in no 12 of annex x, the scientific opinion of the EMEA must be included in the documentation concerning the device.
5.2.1 — The opinion shall be drawn up within 210 days after receipt of valid documentation.
5.2.2 — The notified body will give due consideration to the opinion of the EMEA when making its decision.
5.2.3 — The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable.
5.2.4 — The notified body should convey its final decision to EMEA.
6 — The applicant shall inform the notified body which issued the EC type examination certificate of any modification made to the approved product.
6.1 — Modifications to the approved product must receive further approval from the notified body which issued the EC type-examination certificate where such modifications may affect conformity with the essential requirements or with the conditions of use specified for the product. This new approval shall be issued, where appropriate, in the form of an addendum to the initial EC type-examination certificate.
7 — On request, each notified body shall make available to the other notified bodies and the competent authority, all relevant information on EC type examination certificates and addenda issued, refused or withdrawn.
7.1 — Other notified bodies may obtain a copy of the EC type-examination certificates and/or the addenda to them. The annexes to the certificates shall be made available to the other notified bodies when a reasoned application is made and after the manufacturer has been informed.
7.2 — The manufacturer or his authorized representative shall keep with the technical documentation a copy of the EC type-examination certificates and the addenda to them for a period of, at least, 15 years from the manufacture of the last device.
ANNEX XIII
[mentioned in subparagraph b) of no. 2 of article 8]
EC Verification
1 — EC verification is the procedure whereby the manufacturer or his authorized representative, established within the Community, ensures and declares that the products subject to the provisions of no. 3 are in conformity with the type as described in the EC type- examination certificate and meet the requirements of this decree-law that apply to them.
2 — The manufacturer or his authorized representative established within the Community shall take all measures necessary in order that the
examination certificate and to the requirements of this Directive that apply to them. The manufacturer or his authorized representative, established within the Community, shall affix the CE marking to each product and draw up a written declaration of conformity
3 — The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as
regards sterilization, together with all the routine, pre- established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the EC type examination certificate as well as with the relevant requirements of this Directive.
4 — The manufacturer shall undertake to institute and keep updated a systematic analysis process of the acquired experience with the devices in post-production stage mentioned in annex xvi and to develop suitable means to implement any necessary corrective actions. This undertaking shall include the obligation on the part of the manufacturer to notify the competent authorities of the events mentioned in article 27 of this decree-law, immediately on learning of them:
5 — The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this decree-law by examination and testing of the devices on a statistical basis, as specified in no. 6.
5.1 — The manufacturer must authorize the notified body to evaluate the efficiency of the measures taken pursuant to section 3, by audit where appropriate.
Statisticalverification
6 — The manufacturer shall present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.
6.1 — A random sample shall be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standard(s) referred to in article 6 of the decree-law of which this annex is an integral part, or equivalent tests shall be carried out to verify their conformity to the type as described in the EC type-examination certificate and the provisions of this decree-law that apply to it, and thereby determine whether a batch is to be accepted or rejected.
6.2 — Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards mentioned in article 6 of which this annex is an integral part, taking account of the specific nature of the product categories in question.
6.3 — Where batches are accepted, the notified body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except
for those products from the sample which were found not to be in conformity.
6.3.1 — Where a batch is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the notified body may suspend the statistical verification.
6.3.2 — The manufacturer may, under the responsibility of the notified body, affix the latter's identification number during the manufacturing process.
6.4 — The manufacturer or his authorized representative shall ensure that he is able to supply the notified body's certificates of conformity on request for, at least, 15 years from the date the last device is manufactured.
7 —Upon completing the manufacture of each batch of devices referred to in subparagraph c) of no. 2 of article 2, the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with no. 2 of article 114 of Directive 2001/83/EC, of the European Parliament and the Council, of 6 November (article 135, no. 4 of Decree-law no. 176/2006 of 30 August.
ANNEX XIV
Mentioned in subparagraph b) of no. 2 of article 8]
EC declaration of conformity to type
Assurance of production quality
1 — The manufacturer shall apply the quality system approved for the manufacture and shall conduct the final inspection of the products concerned as specified in 3; he shall be subject to the surveillance provided for in no. 8.
2 — This declaration of conformity is the procedure whereby the manufacturer who complies with the obligations of the previous number guarantees and declares that the concerned devices conform to the type described in the EC type-examination certificate and meet the provisions of the decree-law which apply to them.
2.1 — The manufacturer or his authorized representative shall affix the CE marking in accordance with article 7 of the decree-law of which this annex is an integral part and draws up a declaration of conformity. This declaration shall cover one or more devices manufactured, clearly identified by means of product name, product code or another unambiguous reference and must be kept by the manufacturer.
2.2 — The CE marking shall be accompanied by the identification number of the responsible notified body.
Part I
Quality system
A — Evaluation application
3 — The manufacturer shall submit an application for evaluation of his quality system to a notified body.
3.1 — This application should include:
b) the quality-system documentation;
c) an undertaking to fulfil the obligations arising from the quality system as approved
d) an undertaking to maintain the approved quality system in such a way that it remains adequate and efficient;
e) where appropriate, the technical documentation relating to the approved type and a copy of the EC type- examination certificate;
f) an undertaking by the manufacturer to institute and keep up-dated a systematic analysis process of the acquired experience with devices in post-production stage including the provisions referred to in annex XVI and to develop suitable means for the implementation of any required corrective measures. The undertaking shall include an obligation for the manufacturer to notify the competent authorities of the incidents mentioned in article 27 of this decree-law, immediately on learning of them.
4 — Application of the quality system must ensure that the devices conform to the type described in the EC type-examination certificate.
B — Documentation
5 — All the elements, requirements and provisions adopted by the manufacturer for his quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures.
5.1 — This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records.
5.2 —The documentation should include, in particular, a suitable description of:
a) The manufacturer’s quality objectives;
b) Organization of the business and in particular:
i) The organizational structures;
ii) the responsibilities of the managerial
staff and their organizational authority where manufacture of the products is concerned;
iii) the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of the devices, including control of products which do not conform;
iv) where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;
c) the techniques of control and of quality assurance at the manufacturing stage and in particular:
i) the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents;
ii) product identification procedures drawn up and kept up-to-date from drawings, specifications or other relevant documents at every stage of manufacture;
d) the appropriate tests and trials which will be effected before, during and after production, the
frequency with which they will take place, and the test equipment used.
C — Notified body
6 — Notwithstanding the provisions of nos. 9 to 12 of article 7 of the decree law, of which this annex is an integral part, the notified body shall carry out an audit of the quality system to determine whether it meets the requirements referred to in nos. 4 and 5. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards.
6.1 — The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned.
6.2 — The evaluation procedure shall include an inspection on the manufacturer's premises.
6.3 — The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a
reasoned evaluation.
7 — The manufacturer shall inform the notified body which has approved the quality system of any plan to change that system.
7.1 — The notified body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in 4 and 5; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the inspection and a reasoned evaluation
Part II
Surveillance
8 — The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system.
8.1 — The manufacturer shall authorize the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:
a) The quality-system documentation;
b) The technical documentation;
c) the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardizations/calibrations and the qualifications of the staff concerned.
8.2 — The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.
8.3 — In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report.
9 — The notified body shall convey to the other notified bodies all relevant information concerning approvals of quality systems issued, refused or withdrawn.
Part III
Application to devices incorporating a derivative from human blood according to subparagraph b) of no. 2 of article 2.
10 — Upon completing the manufacture of each batch of devices . referred to in subparagraph b) of no.2 of article 2, the manufacturer
shall inform the notified body of the release of the batch
i) the name of the duly qualified medical practitioner
of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with no. 2 of article 114 of Directive 2001/83/EC of the European Parliament and the Council of 6 November (article 135, no. 4 of decree-law no. 176/2006, of 30 August).
ANNEX XV
(mentioned in no. 4 of article 5)
Statement concerning devices intended for special purposes
1 — The manufacturer or his authorized representative shall draw up for custom-made devices or for devices intended for clinical investigations a statement.
2 — The statement shall include:
2.1 — For custom-made devices, the following particulars:
a) The name and address of the manufacturer;
b) the information necessary for the identification of the concerned device;
c) a statement affirming that the device is intended for exclusive use by a particular patient, together with his name;
d) the name of the duly qualified medical practitioner who drew up the prescription and, if appropriate, the name of the concerned clinic
e) the specific characteristics of the product revealed by the medical prescription;
f) a statement affirming that the device complies with the essential requirements given in annex x and, where applicable, indicating which essential requirements have not been wholly met, together with the respective grounds.
2.2 — For devices intended for clinical investigations covered in Annex XVI, the following particulars:
a) data allowing the devices in question to be identified;
b) the clinical investigation plan;
c) the investigator’s brochure;
d) the confirmation of insurance of the involved subjects;
e) documents used to obtain free and informed consent;
f) a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in nos. 11 and 12 of annex X;
g) A statement asserting whether animal tissues are used or not in the manufacture of the device, such as they are mentioned in Directive no. 2003/32/CE, of the Commission, of 23 April, and chapter VII of decree-law of which this annex is an integral part;
h) the opinion of the ethics committee concerned and details of the aspects covered by its opinion;
or other authorized person and of the institution responsible for the investigations;
j) the place, date of commencement and duration scheduled for the investigations;
l) a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.
3 — The manufacturer shall undertake to keep available for the competent national authorities:
3.1 — For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this decree- law to be assessed.
3.1.1 — The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to the documentation mentioned in no. 3.1;
3.2 — For devices intended for clinical investigations, the documentation shall also contain:
a) A general description of the device and its intended use;
b) design drawings, manufacturing methods, in particular as regards sterilization, and diagrams of parts, sub-assemblies, circuits;
c) the descriptions and explanations necessary for the understanding of the said drawings and diagrams mentioned in the previous subparagraph and of the operation of the product;
d) the results of the risk analysis and a list of the standards laid down in article 6, of the decree-law of which this annex is an integral part, applied in full or in part, and a description of the solutions adopted to meet the essential requirements of the decree-law where the mentioned standards have not been applied;
e) if the device incorporates, as an integral part, a substance or human blood derivative referred to in nos. 11 and 12 of annex x, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device;
f) the results of the design calculations, checks and technical tests carried out;
3.3 — The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to the documentation referred to in 3.1 and 3.2.
3.4 — The manufacturer may authorize the evaluation, by audit where necessary, of the effectiveness of these measures.
4 — The information included in the declarations covered by this Annex shall be kept by the manufacturer
manufacture of the last product.
5 — Regarding the custom-made devices, the manufacturer undertakes to institute a systematic analysis process and keep it updated to analyse the acquired experience
with devices in post-production stage, including the provisions mentioned in annex XVI, and to develop suitable means for the implementation of any required corrective measures. This undertaking should include also the manufacturer’s obligation to notify the competent authorities on the incidents mentioned in article 27 of this decree-law, immediately on leaning of them.
ANNEX XVI
[mentioned in subparagraph z) of article 3]
Clinical evaluation
Part I
General provisions
1 — As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in nos. 1 and 3 of annex I or in the case of active implantable medical devices, in nos. 1 and 2 of annex x, under the normal conditions of use of the device as well as the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in no. 6 of Annex 1, are based, as a rule, on clinical data. The evaluation of this data, hereinafter referred to as clinical evaluation, where appropriate, taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure.
2 — The procedure should be based on:
2.1 — Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where there is demonstration of equivalence of the device to the device to which the data relates and the data adequately demonstrate compliance with the relevant essential requirements;
2.2 — Or a critical evaluation of the results of all the clinical investigations carried out,
2.3 — Or a critical evaluation of the combined clinical data provided in 2.1 and 2.2.
3 — Where necessary to show the equivalence, clinical, technical and biological aspects focusing particularly on performance, operation and work principles and the materials should be taken into consideration.
4 — The manufacturer must prove that the available data are enough to ensure the compliance with this decree- law, taking into account:
4.1 — The demonstration of the equivalence of the device being assessed with the equivalent device placed on the market, if appropriate;
4.2 — The demonstration that data resulting from assessments mentioned in no. 2 apply to the device being assessed;
5 —Where the assessment procedure is based in nos.
2.1 and 2.3 the review of the literature must be carried out by a person or entity duly qualified and aware of the scientific and technical advances.
6 — The final report should include in particular:
6.1 — The plan followed for the selection, collection and assessment of the relevant studies and data;
6.2 — The clear definition of the objective of literature assessment;
6.3 — The identification of the collected data and the recognition of technical journals;
6.4 — The relevance of the gathered data, their assessment and conclusions.
7 — The demonstration of the conformity of the device with the provisions of this decree-law, in particular by means of the procedures mentioned in no. 5, should not be based in reports of single cases or report with no sufficient details to enable a scientific assessment or not substantiated opinions of the conformity.
8 — In the case of implantable devices and devices of class III, clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.
9 — The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.
10 — The clinical evaluation and its documentation must be actively updated with data obtained from the post- market surveillance. Where post-market clinical follow- up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.
11 — Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer.
11.1 — Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.
12 — All data must remain confidential unless it is deemed essential that they be divulged according to article 59 of decree-law of which this annex is an integral part
.
Part II Clinical investigation
13 — The purpose of clinical evaluation is:
a) As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in no. 3 of annex I, or, in the case of active implantable medical devices, in no. 2 of annex X; and
b) To determine any undesirable side effects, under normal conditions of use, and assess whether they are acceptable risks having regard to the intended performance of the device.
14 — Clinical investigations shall be made in accordance with the Declaration of Helsinki approved by the 18th World Medical Assembly in Helsinki, Finland, in 1964, and amended by the 29th World Medical Assembly in Tokyo, Japan, in 1975 and the 35th World Medical Assembly in Venice, Italy, in 1983.
14.1 — It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Declaration of Helsinki. This includes every step in the clinical investigation from first consideration of need and justification of the study to publication of results.
15 — Notwithstanding what has been laid down in nos. 4 and 5 of article 12 of decree-law of which this annex is an integral part, an investigation can only be performed, if regarding the participant in the investigation, or in cases provided for in nos. 16 and 17, as regards their legal authorized representative the following requirements are complied with:
a) During a prio r interview with the in vestig a tor or a member of the investigation team the objectives, risks and inconveniences of the trial, as well as the conditions under which it is going to be performed are fully explained to him in a language suitable for his/her understanding capacity;
b) In the interview mentioned in the previous subparagraph, he/she is informed on the his/her of withdraw from the investigation, at any moment;
c) The right to moral and physical integrity is assured, as well as the right to privacy and protection of personal data concerning him/her are assured, in accordance with the respective legal system;
d) The free and informed consent is, according to the provisions of the law, the corresponding written declaration including information on the nature, scope, consequences and risks of the investigation;
e) The consent where the participant’s personal data are to be handled is obtained;
f) There is an insurance covering the responsibility of the manufacturer, the investigator the respective team rand the owner of the management body of the investigation site, according to the provisions of article 14 of Law no. 46/2004, of 19 August;
g) The medical care provided and medical decisions made regarding the participant are the responsibility of a duly qualified medical practitioner or, if appropriate, a qualified dentist;
h) There is an appointed contact person able to provide more detailed information.
15.1 — The participant, or his/her legal authorised representative may revoke, at any time the free and informed consent, without incurring any responsibility, of any kind, or may be subject to measures questioning the right to health and moral an physical integrity.
15.2 — Revocation does not require any special form, and it can be express or tacit.
15.3 — Revocation carried out by means of a legal authorised representative should reflect the participant’s presumable will and involving no damage for the latter. 16 — In addition to other conditions by virtue of the law, an investigation may only be performed with children
if:
a) If there is the free and informed consent of the respective legal authorised representative, reflecting the presumable will of the child, which can be revoked at any time, with ho damage for the latter;
b) The child has received from qualified staff information on the trial and respective risks and benefits, from a pedagogical point of view. This information is suitable to their understanding capacity;
c) The investigator considers the expressed wish of the child who is able to forma n opinion and assess the
information of refusing to participate or withdraw from the trial at any moment;
d) No incentive or financial benefits shall be granted notwithstanding the reimbursement of expenses and compensation or indemnity for damages incurred with participating in the investigation;
e) The investigation is directly connected with the clinical picture of the child or when, due to its nature, can only be performed with children and involve direct benefits for the participants group, provided it is critical to release data obtained in investigations performed in people capable of giving their free and informed consent or by means of other investigation methods;
f) Pertinent scientific guidelines approved by the competent authority have been complied with in accordance with European guidelines;
g) The investigation has been designed to minimize pain, discomfort, fear or any other predictable risk related to the disease and respective pain level. Also, the risk threshold and pain level should be specifically set out and be permanently monitored;
h) The plan has been approved by the competent ethics committee, according to this decree-law which, for this purpose, should have due competence in terms of paediatrics or obtain counselling on clinical, ethical and psycho-social issues of paediatrics.
17 — Notwithstanding the provisions of no. 15, when an adult participant is not capable of giving his/her free and informed consent, the investigation depends on the cumulative compliance of the requirements mentioned in the following numbers.
17.1 — The participation of adult persons who, before the start of their incapacity, have not given or refused their free and informed consent is only possible if:
a) Their legal authorised representative has given free and informed consent, according to the following number;
b) The person who is incapable of giving free and informed consent has suitable information regarding their capacity to understand the investigation and the respective risks and benefits;
c) The investigator takes into consideration the explicit wish of the participant who can have an opinion and assess the information, of wishing to refuse to participate or withdraw from the investigation at any time;
d) No incentive or financial benefits shall be granted notwithstanding the reimbursement of expenses and compensation or indemnity for damages incurred with participating in the investigation;
e) Investigation is essential to release data from trials performed with people capable of giving their free and informed consent or by means of other investigation methods and is directly connected with the participant’s life danger picture or health debility;
f) The investigation has been designed to minimize pain, discomfort, fear or any other predictable risk related to the disease and respective pain level. Also, the risk threshold and pain level should be specifically set out and be permanently monitored;
g) The plan has been approved by the competent ethics committee, according to this law which, for this purpose, should have due competence in terms of pathology and the concerned population or obtain the respective counselling on clinical, ethical and psycho-social issues of connected with the concerned disease and population;
h) There is the legitimate expectation that the use of the device for investigation brings about to the participant benefits exceeding any risks.
17.2 — The free and informed consent given by the legal authorized representative should reflect the presumable wish of the participant, applying the provisions of nos. 15.1 and 15.2 of this annex.
18 — The clinical investigation should be performed according to the European standard NP EN ISO 14 155 de 2004 or its subsequent reviews, which sets out the procedures for the clinical investigation of medical devices in human beings.
19 — Clinical investigations shall be performed according to an appropriate state of the art plan of investigation according to part 2 of the standard mentioned in the previous number defined in such a way as to confirm or refute the manufacturer's claims for the device; the investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions.
20 — The procedures utilized to perform the investigations shall be appropriate to the device under examination.
21 — Clinical investigations shall be performed in circumstances equivalent to those which would be found in normal conditions of use of the device.
22 — All appropriate features, including those involving the safety and performances of the device, and its effects on the patients, shall be examined.
23 — All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.
24 — The investigations shall be performed under the responsibility of a duly qualified medical practitioner or authorised person in an appropriate environment.
The medical specialist shall have access to the technical data regarding the device.
25 — The written report, signed by the responsible medical specialist, shall comprise a critical evaluation of all the data collected during the
clinical investigations.
ANNEX XVII
(mentioned in no. 2 of article 22)
Minimum criteria to be met when designating the notified bodies
1 — The notified body, its director and the staff responsible for carrying out the evaluation and verification operations cannot be:
a) the designer, manufacturer, supplier or
installer of devices which they control, nor the authorized representative of any of those parties;
b) They may not become directly involved in the design,
construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities.
1.1 — This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.
2 — The notified body and its staff must carry out the evaluation and verification operations with the highest degree of professional integrity and technical competence as regards the medical devices.
2.1 — The notified body and its staff must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications.
2.2 — If a notified body entrusts a third party with the specific works regarding the checking and verification of the facts, it should make sure previously that the former meet the requirements set out in this decree-law.
2.3 — The notified body should keep available to the competent authority the pertinent documents regarding the evaluation of the subcontractor’s competence and the works carried out by the latter in the scope of this decree- law.
3 — The notified body must be capable of ensuring that all tasks ascribed to it in one of the annexes ii to vi of this decree-law or for active implantable medical devices in one of the annexes XI a XIV of this decree-law, whether those tasks are carried out by the body itself or under its responsibility.
3.1 — In particular, it must have at its disposal the necessary staff and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with evaluation and verification; it must also have access to the equipment necessary for the verifications required., which implies that the organization should have enough scientifically trained staff. The staff should have the suitable experience and knowledge e dos to assess in the biological and clinical fields the performance of the devices regarding which it was notified, according to the requirements laid down in this decree- law, in particular, the ones in annex I, or, in the case of active implantable medical devices, in annex X.
3.2 — It should also be provided with access to the equipment required for the mandatory verifications.
4 — The staff responsible for control operations must have:
a) sound vocational training covering all the evaluation and verification operations for which the body has been designated;
b) satisfactory knowledge of the requirements of the controls they carry out and adequate experience of such operations;
c) the ability required to draw up the certificates, records and reports to demonstrate that the controls have been carried out.
5 — The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of controls carried out, or on the results of such controls.
6 —The notified body must take out liability insurance, according to the provisions of a joint decree-order of the members of Government in charge with the health department, unless liability is assumed by the State in
is directly responsible for controls
7 — The staff of the body are bound to observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under this Directive or any provision of national law giving effect to it.
ANNEX XVIII
(mentioned in no. 1 of article 7)
CE Conformity marking
1 — The CE conformity marking shall consist of the initials ‘CE’ taking the following form:
2 — If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be complied with.
3 — The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.
4 — This minimum dimension may be waived for small-scale devices.
ANNEX XIX
(mentioned in article 24.º)
Medical devices manufactured using animal tissues made non-viable or non-viable products derived from animal tissues.
1 — Risk analysis and management:
1.1 — Justification for the use of animal tissues or derivative originating from animals
. — The manufacturer justifies, based on his global strategy of risk analysis and management for a specific medical device, the decision to use tissues or derivative originating from animals mentioned in no. 2 of article 23 of decree-law of which this annex is an integral part
(listing the species and animal tissues), taking into account the expected clinical benefits, the potential residual risk and suitable alternatives.
1.2 — Evaluation procedure. — to guarantee a high level of protection of the patients ad users, the manufacturer of devices using tissues or derivatives originating from animals mentioned in no 1.1 implements a suitable and well reasoned strategy for the risk analysis and management, to deal with all pertinent aspects as regards TSE. In addition it identifies the risks associated with these tissues or derivatives, lays down the documents on the measures taken to minimize the transmission risk and demonstrates the acceptability of the residual risk associated with the device using those tissues or derivatives, taking into account the intended uses and the benefits resulting from that device.
The safety of a device, as to its potential to transmit a transmissible agent, depends on all factors described in nos. 1.2.1 to 1.2.7, which are analyzed, assessed and managed. The combination of these measures determines the safety of the device.
There are two key steps to be considered as follows:
The selection of the starting products (tissues or derivatives) deemed suitable as to their contamination potential by transmissible agents (see nos. 1.2.1, 1.2.2 and 1.2.3), taking into account the subsequent procedure;
The application of a manufacturing process to remove or make transmissible agents present in animal tissues or derivatives of controlled origin inactive (see no. 1.2.4).
In addition, the features of the device and the intended use of the latter are also taken into account (see nos. 1.2.5, 1.2.6 and 1.2.7).
When following the risk analysis and management strategy, the scientific opinions adopted by the pertinent scientific committees, as well as, if appropriate, the opinions of Committee of Proprietary Medicinal Products, whose references have been published in Official Journal of the European Union should also be taken in due consideration.
1.2.1 — The animals as a source of materials. — The risk of TSE depends on the origin species, the strains and the nature of the base tissue. Once the infectivity of BSE accumulates during an incubation period of several years, the supply of young and healthy animals is considered to be a risk reduction factor. Risky animals, such as those found dead, the slaughtered ones in emergency situations and animals suspected of having BSE, have to be excluded.
1.2.2 — Geographical supply. — While awaiting for the classification of countries according to TSE status, in compliance with Regulation (EC) n.º 999/2001, of the European Parliament and the Council, of 22 May, laying down the rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, the risk of the country of origin is assessed based on the geographical risk of BSE (GBR
GBR Level | Presence of one or more bovines clinically or pre-clinically infected with BSE agent, in a region or country |
I II III IV | Highly unlikely. Unlikely but not excluded. Likely but not confirmed, or confirmed at a low level Confirmed at a high level. |
— Geographical BSE Risk). The GBR is a qualitative indicator of the probability of the presence of one or more bovines infected with BSE, either pre-clinically or clinically, at a certain point in a particular country. When this presence is confirmed, GBR indicates the infection level as detailed below :
Certain factors influence the geographic risk of BSE infection associated to the use of tissues or raw derivatives coming from certain countries. These factors are defined in no. 1 of article
2.3.13.2 of International Code of Animal Health of the International Office of Epizooties, which is available on the internet, in xxx.xxx.xxx/xxx/xxxxxx/Xxxxx/X_00000.xxx.
The Scientific Steering Committee has carried out an assessment of the geographical risk of BSE on several third countries and Member States and is still doing that assessment for all countries which have applied for a classification according to the BSE status, taking into account the main factors laid down by the International Office of Epizzoties.
1.2.3 — Nature of the starting tissue. — The manufacturer should take into consideration the risk classification regarding the different types of starting tissues. The supply of animal tissues is subject to control and individual inspection by a veterinary and the carcass should be certified as suitable for human consumption.
The manufacturer should guarantee that there is no cross-contamination risk at the time of the slaughter.
The manufacturer does not use tissues or derivatives originating in animals with a high infectivity potential of BSE, unless the supply of those matters is necessary in special circumstances, taking into account the important benefits for the patients and the lack of alternative starting tissues.
Moreover, the provisions of Regulation (EC) no.1774/2002, of the European Parliament and the Council of 3 October, laying down health rules concerning animal by- products not intended for human consumption.
1.2.3.1 — Sheep and goats. — A infectivity classification was set out for sheep and goats tissues according to the current knowledge, based on the titles of transmissible agents found in organic tissues and fluids of sheep naturally infected and goats with clinical scrapie. In attachment to the opinion of Scientific Steering Committee of 22 and 23 July of de 1999 on «The policy of breeding and genotyping of sheep» there is a table (see note 1), subsequently updated with the opinion of the same Committee under the title «TSE infectivity distributed in ruminant tissues state of knowledge — December 2001», adopted in 10 and 11 January of 2002 (see note 1).
This classification could be reviewed in the light of new
scientific evidence (for instance using pertinent opinions of the scientific committees, of the Committee of Proprietary Medicinal Products and the measures of the European Commission which govern the use of materials showing risks of TSE). An inventory of relevant references to documents/ opinions is published in Official Journal of the European Union; after the decision of the European Commission a list is instituted.
1.2.3.2 — Bovines. — The risk issues specified in Regulation (EC) no. 999/2001 are considered as having a high TSE infectivity potential.
1.2.4 — Inactivation or elimination of transmissible factors:
1.2.4.1 — For devices which cannot undergo an inactivation/elimination process without suffering an unacceptable degradation, the manufacturer has to rely mainly on the supply control.
1.2.4.2 — For other devices if the manufacturer claims that in the manufacturing processes it is possible to eliminate or make inactive the transmissible agents he is bound to confirm it with the suitable documents.
The pertinent information resulting from suitable investigation and analysis of scientific literature may be used to justify inactivation/elimination factors
when the specific processes mentioned in the literature are comparable with the ones used for the device. These investigation and analysis should also comprise the available scientific opinions that may have been adopted by a scientific committee of the European Union. The mentioned opinions are used as references in cases where there are disagreeing opinions.
If these allegations cannot be confirmed based on bibliographic research, the manufacturer should launch a specific study on inactivation and, or elimination on a scientific basis, taking into account the following factors:
The identified risks associated with the tissue; Identification of pertinent model agents;
Justification for the selection of the specific combinations of the model agents;
Identification of the stage selected to eliminate or make the transmissible agents inactive;
Calculation of the reduction factors.
The final report should identify the parameters and the manufacture limits deemed to be critical for the efficiency of the inactivation or elimination process.
During the manufacture, the application of the validated processing parameters is guaranteed due to the use of well documented procedures.
1.2.5 — Quantities of starting tissues or animal derivatives necessary to produce a unit of the medical device. — The manufacturer assesses the quantity of tissues or raw animal derivatives necessary to produce a single unit of the medical device. In case of purification process the manufacturer should assess if that process has potential to concentrate the levels of transmissible agents present in the starting tissues or derivatives originating on animals.
1.2.6 — Tissues or derivative originating in animals which come into contact with the patients or the users. — The manufacturer takes into consideration:
i) The quantity of tissues or derivatives originating in animals;
ii) The contact area: its surface, type (for instance, skin, mucosae, brain, etc.) and state (for instance, healthy or damaged);
iii) The type of tissues or derivatives which come into contact with the patients and or the users;
iv) The time during which the device is expected to be into contact with the body (including the bio- reabsortion process).
The number of medical devices which can be used in a specific procedure is taken into consideration.
1.2.7 — Administration route . — The manufacturer takes into account the highest risk administration route recommended with the information on the product.
1.3 — Evaluation review. — The manufacturer sets out and keeps a systematic procedure of review of the information gained on its medical devices or other similar ones in post-production stage. The information is assessed based on its pertinence to safety in particular:
a) If previously unknown risks are detected;
b) If the calculated risk of a specific hazard is no longer acceptable;
c) If the initial assessment has in some way become not valid anymore.
If any of these factors is reported, the results of the assessment are conveyed and included in the risk management file.
With this new information, a review of the suitable risk management measures which apply to the device should be considered (including the justification of the selection of a specific tissue or derivative originating from an animal). If the residual risk or its acceptability may have undergone changes, the impact of these changes on the control measures of the risk previously implemented is reassessed and justified.
The results of this assessment have to be documented. 2 — Assessment of the medical devices in class III
by the notified bodies. — As for devices in class III according to rule 17 of annex IX of this decree-law, the manufacturers should provide the notified bodies with all the pertinent information to enable the full assessment of their current strategy of the risk analysis and management. Any new information on TSE obtained by the manufacturer and pertinent for its devices is sent to the notified body for information.
Any changes to the supply, recall, processing and inactivation/elimination processes, which may modify the results of the manufacturer’s risk management dossier are conveyed to the notified body for additional approval prior to its implementation.
ANNEX XX
(mentioned in no. 5 of article 28)
Organization
1 — National Surveillance System of Medical Devices («System») comprises a structure which includes:
a) The competent authority through its office in charge of the surveillance of medical devices;
b) The manufacturers and the authorized representatives;
c) The dealers;
d) The public or private units and undertakings of health care provision;
e) Health professionals;
f) Other users;
g) The notified bodies, when appropriate.
Competent Authority
2 — In the scope of the System, the competent authority takes the necessary measures for the reception and handling of information regarding incidents and safety corrective measures regarding medical devices, for technical or medical reasons, with the aim to, in particular:
a) Set out, develop and disseminate the most suitable procedures to get information on incidents resulting from the use of medical devices;
b) Receive, record and assess centrally notifications provided for in nos. 4 and 5 of this annex;
c) If appropriate, inform the manufacturer of the notifications on the incidents submitted by the health professionals and other users;
d) Guarantee the investigation of the incidents and the implementation of the appropriate preventive or corrective measures for the risk mitigation;
e) Carry out studies regarding the performance and safety of the use of the medical device and their benefit-risk ratio;
f) Propose, where appropriate, safety recommendations for the use of the medical devices;
g) Disseminate information and ensure training in the field of medical devices surveillance.
h) Cooperate and share information, in the scope of safety, with the other competent authorities and, in case of recall of a medical device notify the European Commission and the competent authorities of the other Member States;
i) Cooperate with other public or private entities, especially universities, in activities relevant for this field.
2.1 — The competent authority should ensure, in particular, the suitable interaction with health professionals, other users, and with the manufacturers and authorised representatives and dealers, with regards to the safety of the medical devices, as well as the safety corrective actions to develop.
Particulars to make available to the competent authority
3 — Where the competent authority deems necessary any of the particulars indicated below are made available by the manufacture or its authorized representative:
a) Declaration of conformity and technical documents supporting the design and the manufacture of the concerned medical devices, as well as the decisions and reports of the notified body involved in the assumption of conformity;
b) Documentation, containing data of the pre- clinical investigation stages, especially the information in annex VIII of the decree-law of which this annex is an integral part and in annex VIII of Decree- Law no. 189/2000, of 12 August;
c) Reports regarding clinical investigations referred to in no. 25 of annex XVI of the decree-law of which this annex is an integral part;
d) Other documentation necessary for the national marketing authorization which is filed in the registered office of the manufacturer or its authorised representative;
e) Information regarding the design, manufacture, storing, distribution and marketing traceability of the concerned device or devices;
f) Information regarding the sale, use and when appropriate, the prescription of the concerned device or devices.
Incidents notification
4 — In addition to the obligations imposed by the standards mentioned in the previous number, the manufacturers, their authorised representatives and the dealers should notify the competent authority all the information regarding incidents, occurred in Portugal, after the devices have been placed on the market, according to the provisions of article 27 of the decree-law, of which this annex is an integral part.
Health Professionals and other users
5 — The health professionals, with National Health Service or other professional users of medical devices and other parties interested in the safety of the medical devices should notify the competent authority , as soon as possible, the incidents specified in article 27 of decree-law of which this annex is an integral part of which they are aware of, notwithstanding the possibility of notifying also the manufacturers, their authorized representatives and dealers about those incidents.
Suspicious medical devices
6 — The health professionals should keep suspicious medical devices to investigate incidents
Manufacturers and authorised representatives
7 — The manufacturers or their authorised representatives should have a representative with suitable legal and technical qualifications for the surveillance issues regarding medical devices, with the purpose of ensuring their responsibilities in the field of surveillance of medical devices.
7.1 — Accordingly, the manufacture or his representative should:
a) Convey to the competent authority all information regarding the contact ways and the appointment of the representative mentioned in the previous number, as well as any change of those persons;
b) Send to the competent authority the notifications of incidents and corrective actions which take place in national territory;
c) Send to the competent authority the notifications of incidents and safety corrective actions which take place in the territory of a State which is not part o f the Agreement on the European Economic Area, in the case of a manufacturer or authorised representative with registered office in Portugal, or the notified body responsible for the assessment of its product with a registered office also in Portugal;
d) Institute and keep updated a systematic analysis process of the acquired experience with the devices in post-production stage and to develop suitable means to implement any necessary corrective actions;
e) Investigate incidents occurred with medical devices manufactured or put on the market by it of which they become aware of, notifying and keeping informed the competent authority on its evolution;
f) Propose and carry out in accordance with the competent authority, the suitable preventive and or corrective measures for the results of the investigation carried out;
g) Ensure, a ready and full response to the requests of the competent authority regarding the provision of additional information required for the assessment of the benefits and risks resulting from the use of a medical device;
that is requested by the latter regarding initiatives aiming at the improvement of the System operation.
7.2 — The manufacturer, or its authorised representative should comply with the following timeframes as for the notifications to send to the competent authority:
a) The initial report should be submitted immediately, unless the delay may be duly justified, a timeframe of two days being set out as the limit, in situations involving a serious threat for public health.
b) The initial report should be submitted as soon as possible, a timeframe of 10 days being set out as the limit,
in situations involving death or high health risk, or 30 days in the other cases;
c) The initial report should be submitted as soon as the investigation i s considered to be concluded, a timeframe of 10 days after the conclusion being set out as the limit;
d) In case the investigation provided for in the previous subparagraph is not conclusive, a follow-up report is likely to be submitted, by means of a proposal
by the entity responsible for the marketing or the competent authority’s demand. The submission date should be agreed between both parties or in case of disagreement, established by the competent authority;
e) The corrective action report and the respective safety warning should be submitted within two days before the date of the proposal by the entity responsible for the marketing for the beginning of the mentioned action, except in the cases involving a serious threat for public health;
f) In cases of serious threat for public health the safety corrective action should be started immediately and conveyed to the competent authority, unless the delay may be duly justified, the beginning of the action not being subject to the response of the competent authority;
g) The completion of the safety corrective action requires the competent authority to be informed that the action has been implemented in Portugal, and, when appropriate, also to the submission of a reconciliation report including the number of the units per collection location, the destiny to give to the mentioned units and, when appropriate, the reasons to collect a number of units lower than what was initially set out, as well as other information which the entity responsible for the marketing deems pertinent to mention ;
h) In specific situations the competent authority may accept that the manufacturer, or its authorized representative carries out the notification of the occurred incidents by means of a short periodical report or trend report, when one or more initial reports have already been assessed by the manufacturer and the competent authority.
Notified bodies
8 — The competent authority may, when appropriate, consult with the notified body responsible for the EC marking affixation on a medical device, following an incident or safety corrective action involving the mentioned device.
Experts
9 — The drawing up of opinions on issues related to the surveillance of medical devices may be, when appropriate,
requested from experts of recognised capacity and technical and scientific competence, in particular through specialized technical commissions of the competent authority.
TRIBUNAL CONSTITUCIONAL
Acórdão do Tribunal Constitucional n.º 187/2009
Processo n.º 760/08
Acordam no plenário do Tribunal Constitucional:
A razão pela qual o Tribunal, em sede de fiscalização concreta nas decisões invocadas pelo requerente, julgou organicamente inconstitucional a norma do artigo 138.º, n.º 2, do Código da Estrada, foi o facto de ela ter alargado o âmbito de aplicação da norma que pretendeu substituir, sem que houvesse na Lei n.º 53/2004, de 4 de Novembro, que concedeu ao Governo a autorização para proceder à revisão do Código da Estrada ao abrigo da qual foi pu- blicado o Decreto-Lei n.º 44/2005, qualquer referência à possibilidade de o fazer.
De facto, o artigo 139.º, n.º 4, da redacção anteriormente vigente do mesmo Código da Estrada, tinha o seguinte teor:
I — Relatório
1 — O representante do Ministério Público junto do Tribunal Constitucional requereu, nos termos do artigo 82.º da Lei de Organização, Funcionamento e Processo do Tri- bunal Constitucional, aprovada pela Lei n.º 28/82, de 15 de Novembro, e alterada, por último, pela Lei n.º 13-A/98, de 26 de Fevereiro (LTC), a apreciação e a declaração, com força obrigatória geral, da inconstitucionalidade da norma constante do artigo 138.º, n.º 2, do Código da Estrada, na redacção dada pelo Decreto-Lei n.º 44/2005, de 23 de Fevereiro, na parte em que determina que seja punido por crime de desobediência qualificada quem conduzir veículos automóveis estando proibido de o fazer por força da aplicação da pena acessória prevista no artigo 69.º do Código Penal, constante de sentença criminal transitada em julgado.
O pedido funda-se no facto de o Tribunal Constitucio- nal já ter julgado, no âmbito da fiscalização concreta, tal norma organicamente inconstitucional, por preterição do artigo 165.º, n.º 1, alínea c), da Constituição, no Acór- dão n.º 574/2006 e nas decisões sumárias n.os 58/2008 e 137/2008.
Notificado nos termos e para os efeitos dos artigos 54.º e 55.º, n.º 3, da LTC, o Primeiro-Ministro, em resposta, ofe- receu o merecimento dos autos.
2 — Discutido o memorando apresentado pelo Presi- dente do Tribunal, cumpre formular a decisão em confor- midade com a orientação fixada.
II — Fundamentação
3 — A norma que agora é objecto do pedido de de- claração de inconstitucionalidade com força obrigatória geral consta do artigo 138.º, n.º 2, do Código da Estada, na redacção dada pelo Decreto-Lei n.º 44/2005, de 23 de Fevereiro, que estatui o seguinte:
«Quem praticar qualquer acto estando inibido ou proibido de o fazer por sentença transitada em julgado ou decisão administrativa definitiva que aplique uma sanção acessória é punido por crime de desobediência qualificada.»
Este preceito remete, pois, para o artigo 348.º, n.º 2, do Código Penal, que estabelece a pena aplicável ao crime de desobediência qualificada nos termos seguintes:
«A pena é de prisão até 2 anos ou de multa até 240 dias nos casos em que uma disposição legal cominar a punição da desobediência qualificada.»
«Quem conduzir veículo a motor estando inibido de o fazer por sentença transitada em julgado ou decisão administrativa definitiva é punido por desobediência qualificada.»
Ora, limitando-nos neste passo à comparação das ver- sões do Código da Estrada em sucessão, o teor destes dois preceitos não coincide. Como se explicou no Acórdão n.º 114/08, houve uma alteração do âmbito de aplicação:
«Cotejando os preceitos transcritos, verifica-se que, além da diferente numeração, e da alteração da epígrafe do preceito, existem as seguintes diferenças entre os textos legais em comparação:
i) Onde anteriormente se dizia ‘Quem conduzir veí- culo a motor […]’, agora diz-se ‘Quem praticar qualquer acto’;
ii) Onde se dizia ‘[...] estando inibido de o fazer’, passou a dizer-se ‘[...] estando inibido ou proibido de o fazer’.»
Na parte em que a norma não é inovadora, explica o mesmo Xxxxxxx, não há qualquer inconstitucionalidade:
«Com efeito, o Tribunal já por diversas vezes afirmou, em jurisprudência que remonta à Comissão Constitucional, que o facto de o Governo aprovar actos normativos respei- tantes a matérias inscritas no âmbito da reserva relativa de competência da Assembleia da República não determina, por si só e automaticamente, a invalidação das normas que assim decretem, por vício de inconstitucionalidade orgâ- nica. Força é que se demonstre que as normas postas sob observação não criaram um regime jurídico materialmente diverso daquele que até essa nova normação vigorava, limitando-se a retomar e a reproduzir substancialmente o que já constava de textos legais anteriores emanados do ór-
gão de soberania competente [Cf. os Acórdãos n.os 502/97, 589/99, 377/02, 414/02, 450/02, 416/03 e 340/05 estes
tirados em Secção e publicados no Diário da República, 2.ª série, de 4 de Novembro de 1998, de 20 de Março de 2000, de 14 de Fevereiro de 2002, de 17 de Dezembro de
2002, de 12 de Dezembro de 2002, de 6 de Abril de 2004 e de 29 de Julho de 2005, bem como o Acórdão n.º 123/04 (plenário) publicado no Diário da República, 1.ª série-A, de 30 de Março de 2004. Cf. ainda, aliás com posição discordante, a indicação de Xxxxx Xxxxxxx, Manual de Direito Constitucional, t. V, pp. 234/235].»
Contudo, a norma do artigo 138.º, n.º 2, agora impug- nada, não se limitou a substituir o antigo artigo 139.º, n.º 4, do Código da Estrada; alargou o seu âmbito de aplicação. Foi, por isso, julgada organicamente inconstitucional no