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
Applicable from 26 May 2022
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 May 2022
Guide for application:
European Commission contact point:
Directorate-General for Health and Food Safety
For information about the content and availability of European standards, please contact the European Standardisation Organisations.
Publications in the Official Journal
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
- Amendment of 6 January 2022 to Implementing Decision (EU) 2021/1195
- Amendment of 11 May 2022 to Implementing Decision (EU) 2021/1195
- Amendment of 4 July 2023 to Implementing Decision (EU) 2021/1195
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Summary list of titles and references of harmonised standards
The summary below consolidates the references of harmonised standards published by the Commission in the Official Journal of the European Union (OJ). It reproduces information already published in the L series of the OJ. It contains all references which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.
The Commission services provide this summary for information purposes only. Although they take every possible precaution to ensure that the summary is updated regularly and is correct, errors may occur and the summary may not be complete at a certain point in time. The summary does not as such generate legal effects.