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Medical devices Directive 93/42/EEC

CE mark medical device directive
CE mark medical device directive

Short name:Medical devices
Base:Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
OJ L 169 of 12 July 1993
Modification:Directive 93/68/EEC [CE Marking]Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devicesDirective 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasmaDirective 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devicesDirective 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
Directive repealed:76/764/EEC (repealed as from 1 January 1995)
Guide for application:Guidance on CE marking for professionalsGuidelines related to medical devices directives
European Commission contact point:Directorate-General for Health and Food Safety
Medical devices
Email
Webpage on medical devices
For information about the content and availability of European standards, please contact the European Standardisation Organisations.

Since 1 December 2018 the references of harmonised standards are published in, and withdrawn from the Official Journal of the European Union by means of ‘Commission implementing decisions’.

The references published under Directive 93/42/EEC on medical devices are found in Commission Implementing Decision (EU) 2020/437 of 24 March 2020 (OJ L 90I, 25 March 2020) listed below. The decision applies until 26 May 2024.

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