Internal Market, Industry, Entrepreneurship and SMEs

In vitro diagnostic medical devices

In vitro diagnostic medical devices

Directive 98/79/EC

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

Modification:

[-]

Guide for application:

European Commission contact point:

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

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

Since 1 December 2018 the references of harmonised standards are published in, and withdrawn from the Official Journal of the European Union by means of 'Commission implementing decisions'.

The references published under Directive 98/79/EC on in vitro diagnostic medical devices are found in Commission Implementing Decision (EU) 2020/439 of 24 March 2020 (OJ L 90I , 25 March 2020) listed below. The decision applies until 26 May 2024.