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In vitro diagnostic medical devices

Directive 98/79/EC - applicable until 25.05.2022, repealed by Regulation (EU) 2017/746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 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
European Commission contact point

Directorate-General for Health and Food Safety
Medical devices
SANTE-MED-DEVatec [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

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

Consolidated text: Commission Implementing Decision (EU) 2020/439 of 24 March 2020