Medical devices

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:

• Guidance on CE marking for professionals
• Guidelines related to medical devices regulations

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.