Directive 90/385 definition

Directive 90/385 means Council Directive 90/385/EEC of 20th June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(1), as amended(2);
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Examples of Directive 90/385 in a sentence

  • In this Regulation, any reference to Annex 8 to Directive 90/385 or to Annex XI to Directive 93/42 is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A to the Medical Devices Regulations 2002.”.

  • The applicable rules on good clinical practice in clinical trials with medical devices were incorporated into Swiss legisla- tion by way of reference to annexes VIII and X to the Direc- tive 93/42/EEC, annexes 6 and 7 to the Directive 90/385/ EEC, and Article 42 of the Guidelines on Medical Devices (MEDDEV 2.7/3) of December 2010, as well as in EN ISO 14155.

  • In addition application for modifications can be submitted in a uniformed way to the European Commission responsible for maintenance the NANDO register.This document is applicable to products according to Directive 93/42/EEC (MDD) concerning medical devices, Directive 90/385 (AIMDD) concerning active implantable medical devices and Directive 98/79/EC (IVDMDD) on in vitro diagnostic medical devices.

  • IMQ Med Services Designation• Notified ody for Medical Device Directive /93 42/ • Notified Body for Implantable Active Medical Device Directive 90/385/ creditations and agreements • sting laboratory for ACCREDIA ILAC marks• IEC and IECEE: IMQ is NCBTL laboratory for the CB Scheme • MDSAP programsting laboratory for Non-Active Medical Device in the CSI IMQ laboratory Summary 1.

  • Another important player is the Ministry of Internally Displaced Persons from Occupied Territories, Labor, Health and Social Affairs of Georgia which covers the implementation of the following EU Directives: Directive 93/42 / EEC on medical devices; Directive 90/385 /EEC on actively implantable medical devices; Directive 98/79/EC on in-vitro diagnostic medical devices.

  • Incident reporting requirements and procedures do not change significantly, and the require- ments of Active Implantable Medical Devices Directive 90/385 / EC (AIMDD), Medical Device Directive 93/42 / EEC (MDD), Device Directives In Vitro Medical Devices 98/79 / EC (IVDD), Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) can be used for the CE marking.

  • The definition of a medical device is set forth in the Medical Devices Act of May 20, 2010, Journal of Laws of June 17, 2010 no.107, item 679 (“Medical Devices Regime”), which implements, inter alia, the amended Council Directive 90/385 and 93/42.

  • The Regulation 2017/745 (hereafter “MDR”), which is relevant for the present studypppp, replaces Directive 90/385 on active implantable medical devices and Directive 93/42 on medical devices (hereafter “AIMDD” and “MDD”).‌‌‌‌‌ kkkk Directive 93/42/EEC concerning medical devices.

Related to Directive 90/385

  • 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);

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

  • Directive means EC Council Directive 2001/23/EC

  • Industrial Emissions Directive means DIRECTIVE 2010/75/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 November 2010 on industrial emissions

  • Labor law decision means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

  • Environmental, Health or Safety Requirements of Law means all Requirements of Law derived from or relating to foreign, federal, state and local laws or regulations relating to or addressing pollution or protection of the environment, or protection of worker health or safety, including, but not limited to, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq., the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., and the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., in each case including any amendments thereto, any successor statutes, and any regulations or guidance promulgated thereunder, and any state or local equivalent thereof.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Change Directive means a written order signed by the procurement officer that

  • 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;

  • Environmental and Social Management Framework or “ESMF” means the framework included in the EA setting out modalities to be followed in assessing the potential adverse environmental and social impact associated with activities to be implemented under the Project, and the measures to be taken to offset, reduce, or mitigate such adverse impact.

  • medical authority means the medical authority as referred to in clause (p) of section 2 of the Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995 or such other medical authority as may, by notification, be specified by the Central Government for certifying “autism”, “cerebral palsy”, “multiple disabilities”, “person with disability” and “severe disability” referred to in clauses (a), (c), (h), (j) and (o) of section 2 of the National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999;

  • Directives means intergovernmental, interagency, or interdepartment administrative or procedural guidelines or instructions which do not affect the rights of, or procedures and practices available to, the public.

  • Solvency II Directive means Directive 2009/138/EC of the European Parliament and of the Council of the European Union of 25 November 2009 on the taking-up and pursuit of the business of insurance and reinsurance (Solvency II);

  • 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.

  • Applicable Governmental Authority means the FERC within the United States and the appropriate governmental authority with subject matter jurisdiction over reliability in Canada and Mexico.

  • Local Mental Health Authority means a county legislative body.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Health Authority means the regional health board designated under the Health Authority Act, RSBC 1996, c.180, or the Provincial Health Services Authority, to which the Participant is designated under Schedule 1 (Return of Service Placement Process) of this Contract, unless designated otherwise by the Province;

  • Environmental and Social Management Plan or “ESMP” means a site-specific environmental and social management plan to be prepared in accordance with the parameters laid down in the ESMF and acceptable to the Association, setting forth a set of mitigation, monitoring, and institutional measures to be taken during the implementation and operation of the Project activities to eliminate adverse environmental and social impacts, offset them, or reduce them to acceptable levels, and including the actions needed to implement these measures.

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, and ordinances concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, as such requirements are enacted and in effect on or prior to the Closing Date.

  • Construction Change Directive means a written order prepared by Owner Parties and signed by Owner directing Contractor to perform a change in the Work prior to agreeing to a change, if any, to the Contract Time, schedule of performance of the Work, Contract Sum, or Contractor’s compensation.

  • CRD IV Directive means Directive 2013/36/EU on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms of the European Parliament and of the Council of 26 June 2013, as the same may be amended or replaced from time to time.

  • Disaster Management Act means the Disaster Management Act, 2002 (Act No.57 of 2002)

  • Occupational Health and Safety Act means the Occupational Health and Safety Act, 1993 (Act No 85 of 1993);

  • Elective Treatment and Procedures means any medical treatment or surgical procedure that is not medically necessary, including any service, treatment, or supplies that are deemed by the federal, or a state or local government authority, or by Us to be research or experimental or that is not recognized as a generally accepted medical practice.

  • Local Authority Associated Persons means any person associated with any local authority within the meaning given in section 69 of the Local Government and Housing Act 1989;