Short name: | Medical devices |
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Base: | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC OJ L 117 of 5 May 2017 Applicable from 26.05.2021 |
Modification: | Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189 of 20 July 1990 Applicable until 25.05.2021 The references published under Directive 90/42/EEC on active implantable medical devices Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169 of 12 July 1993 Applicable until 25.05.2021 See references published under Directive 93/42/EEC on medical devices |
Guide for application: | |
European Commission contact point: | Directorate-General for Health and Food Safety Medical devices SANTE-MED-DEVec [dot] europa [dot] eu (Email) Webpage on medical devices |
For information about the content and availability of European standards, please contact the European Standardisation Organisations.
Publications
Publications in the Official Journal
- Amendment of 4 January 2022 to Implementing Decision (EU) 2021/1182
- Amendment of 11 May 2022 to Implementing Decision (EU) 2021/1182
- Amendment of 4 July 2023 to Implementing Decision (EU) 2021/1182
- Amendment of 6 March 2024 to Implementing Decision (EU) 2021/1182
- Amendment of 8 October 2024 to Implementing Decision (EU) 2021/1182
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Summary list of titles and references of harmonised standards
The summary below consolidates the references of harmonised standards published by the Commission in the Official Journal of the European Union (OJ). It reproduces information already published in the L series of the OJ. It contains all references which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.
The Commission services provide this summary for information purposes only. Although they take every possible precaution to ensure that the summary is updated regularly and is correct, errors may occur and the summary may not be complete at a certain point in time. The summary does not as such generate legal effects.