EU Medical Devices Directive definition

EU Medical Devices Directive means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended or supplemented from time to time.
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Examples of EU Medical Devices Directive in a sentence

  • Conforms to EU Medical Devices Directive 93/42/EEC, Class I and EN 14683 standard for type IIR (or equivalent international standard).

  • The Package Insert is in compliance with the EU Medical Devices Directive (93/42/EEC), and is subject to an annual review by the designated EU Notified Body.

  • Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a Member State of the EEA to conduct conformity assessments, or a Notified Body.

  • Some examples of how the EU Medical Devices Directive could be strengthened: Compulsory notification to the Competent Authority (CA): Under the current system, Notified Bodies are responsible for reviewing CE Marking applications, and grant approval for products to be placed on the market in Europe.

  • The quality of medical devices is covered by the EU Medical Devices Directive (REF04), see Annex A for more on this.

  • The products commercialized or used by the Company and its Subsidiaries in the European Economic Area, which is composed of the Member States of the European Union, Norway, Liechtenstein and Switzerland, do not qualify as Medical Devices or Medical Device accessories under the EU Medical Devices Directive (Directive 93/42/EEC, as amended).

  • Persuading a manufac- turer to tailor and provide a non-standard sequence has recently become very difficult, due to the require- ments for good manufacturing practice, and satisfy- ing medical equipment regulatory bodies such as the Medical Devices Directorate in the UK and the Fed- eral Food and Drugs Administration in the USA, and legislation such as the EU Medical Devices Directive.

  • The results from evaluation will be combined with study results and other development information from CardioTech International Ltd to allow an application to be made to an Ethics Committee leading to a pilot clinical investigation with the objective of determining the short term clinical performance of the grafts, providing the clinical information required to comply with the essential requirements of the EU Medical Devices Directive.

  • The MPG will have to be revised to comply with the new EU Medical Devices Directive, and the new IVD Medical Device Directive, in effect since May 26, 2017.

  • The EU Medical Devices Directive 93/42 established a four-part classification system for medical devices.

Related to EU Medical Devices Directive

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Consumables and medical devices means (consumables) items that require regular replacement (e.g. batteries) to keep a medical device (such as a hearing aid) operational. Many medical devices require consumables.

  • Waste Framework Directive or “WFD” means Waste Framework Directive 2008/98/EC of the European Parliament and of the Council on waste.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Medical direction means direction, advice, or orders provided by a medical director, supervising physician, or physician designee (in accordance with written parameters and protocols) to emergency medical care personnel.

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.

  • UCITS Directive means Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities, as amended;

  • Advance health care directive means a power of attorney for health care or a record signed or authorized by a prospective donor containing the prospective donor’s direction concerning a health care decision for the prospective donor.

  • Qualified medical direction means, in the context of the practice of respiratory care, having readily

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • HITECH means the Health Information Technology for Economic and Clinical Health Act.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • CRD Directive means the Directive (2013/36/EU) of the European Parliament and of the Council on prudential requirements for credit institutions and investment firms dated 26 June 2013 and published in the Official Journal of the European Union on 27 June 2013 (or, as the case may be, any provision of Danish law transposing or implementing such Directive), as amended or replaced from time to time (including, for the avoidance of doubt, the amendments to such Directive resulting from Directive (EU) 2019/878 of the European Parliament and of the Council as regards exempted entities, financial holding companies, mixed financial holding companies, remuneration, supervisory measures and powers and capital conservation measures dated 20 May 2019 and published in the Official Journal of the European Union on 7 June 2019);

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Clinical supervision means direction or oversight provided either face to face or by videoconference or telephone by an individual qualified to evaluate, guide, and direct all behavioral health services provided by a licensee to assist the licensee to develop and improve the necessary knowledge, skills, techniques, and abilities to allow the licensee to engage in the practice of behavioral health ethically, safely, and competently.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;

  • Clinical supervisor means any of the following:

  • Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.

  • Rural health clinic means a rural health clinic as defined under section 1861 of part C of title XVIII of the social security act, chapter 531, 49 Stat. 620, 42 U.S.C. 1395x, and certified to participate in medicaid and medicare.

  • Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.