In vitro diagnostic medical devices
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
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
Guide for application:
European Commission contact point:
For information about the content and availability of European standards, please contact the European Standardisation Organisations.
The references published under Directive 98/79/EC on In Vitro Diagnostic 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) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council - OJ L 90I , 25 March 2020