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Лого на Европейската комисия
Internal Market, Industry, Entrepreneurship and SMEs

In vitro diagnostic medical devices

Regulation (EU) 2017/746

Short name:

In vitro diagnostic medical devices

Base:

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

Modification:

[-]

Directive repealed

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

See references published under Directive 98/79/EC 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.

Publications

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

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

 

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which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.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.

Summary list as pdf document

Summary list as xls file

Multilingual legend for the summary list