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Internal Market, Industry, Entrepreneurship and SMEs

Medical devices

Directive 93/42/EEC - applicable until 25.05.2021, repealed by Regulation (EU) 2017/745

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
SANTE-MED-DEVatec [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.

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