Directive 98/79/EC - applicable until 25.05.2022, repealed by Regulation (EU) 2017/746
- 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 1998Applicable 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
- European Commission contact point
Directorate-General for Health and Food Safety
Medical devices
SANTE-MED-DEV
ec [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.
Publications
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
Consolidated text: Commission Implementing Decision (EU) 2020/439 of 24 March 2020