Medical devices

Regulation (EU) 2017/745

Short name

Medical devices

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

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

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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which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.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.