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The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC. [5] ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF). [6]
The Annex ZA harmonized ISO 14971:2012 with the Medical Devices Directive 93/42/EEC of 1993. [8] The Annex ZB harmonized ISO 14971:2012 with the Active Implantable Medical Device Directive 90/385/EEC of 1990. [9] The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998. [10]
Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products which, under Articles 9 and 10 of the Treaty, must be admitted for free movement, as regards laws, regulations or administrative provisions prohibiting the use of the said products and prescribing the use of national products or making such use subject ...
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)