Internal Market, Industry, Entrepreneurship and SMEs

In vitro diagnostic medical devices

In vitro diagnostic medical devices

Directive 98/79/EC, 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

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Since 1 December 2018 the references of harmonised standards are published in, and withdrawn from the Official Journal of the European Union by means of 'Commission implementing decisions'.

Publications in the Official Journal (Regulation (EU) 2017/746)

Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
BG CS DA DE EL EN ES ET FI FR GA HR HU IT LT LV MT NL PL PT RO SK SL SV PDF Format

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.

Publications in the Official Journal (Directive 98/79/EC)

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
BG CS DA DE EL EN ES ET FI FR HR HU IT LT LV MT NL PL PT RO SK SL SV PDF Format

Consolidated text: Commission Implementing Decision (EU) 2020/439 of 24 March 2020
BG CS DA DE EL EN ES ET FI FR HR HU IT LT LV MT NL PL PT RO SK SL SV PDF Format

Stay up to date with the references of harmonised standards for these directives, published in the Official Journal by subscribing to the RSS feed RSS

Previous publications in the Official Journal (Directive 98/79/EC)

Commission communication 2017/C 389/04 repealed by  Commission Implementing Decision (EU) 2020/439 of 24 March 2020:

Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices - OJ C 389 of 17 November 2017
BG CS DA DE EL EN ES ET FI FR HR HU IT LT LV MT NL PL PT RO SK SL SV PDF Format