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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

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
Email
Webpage on medical devices

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

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