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Internal Market, Industry, Entrepreneurship and SMEs

Medical devices

Directive 93/42/EEC

Short name:

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



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

See references published under Regulation (EU) 2017/745 on medical devices

Guide for application:

European Commission contact point:

Directorate-General for Health and Food Safety
Medical devices
Webpage on medical devices

For information about the content and availability of European standards, please contact the European Standardisation Organisations.

The references published under Directive 93/42/EEC on medical devices are found in the Commission implementing decision listed below. The decision applies until 26 May 2024.


Publications in the Official Journal

Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC - OJ L 90I , 25 March 2020

Consolidated text: Commission Implementing Decision (EU) 2020/437 of 24 March 2020