In vitro diagnostic medical devices

Short name:

In vitro diagnostic medical devices

Base:

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
OJ L 331 of 7 December 1998

Applicable until 25.05.2022

Modification:

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

OJ L 117 of 5 May 2017

Applicable from 26.05.2022

See references published under Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices.

Guide for application:

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

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.