Regulation extending the validity of medical device certificates adopted

On 7 March 2023, the Council of the European Union adopted a regulation extending the validity of certificates under the Medical Devices Directives. The regulation also removes restrictions on the end date of sale of medical devices and in vitro diagnostic devices conforming to the directives. These measures will reduce the potential risk of shortages of medical devices. The regulation shall enter into force immediately after its publication in the Official Journal within the coming weeks.

The expiry date for certificates in accordance with the directives as defined in the MDR is 26 May 2024. The adopted regulation extends the validity dates of certificates to the end of 2027 or 2028, depending on the risk category of the device.

Further information:

European Commission press release 7 March 2023: Council takes action to mitigate risk of medical devices shortage - Consilium (europa.eu)

Amending Regulation (all official languages): EUR-Lex - 52023PC0010 - EN - EUR-Lex (europa.eu)

Fimea news item 11 January 2023: Commission proposes extension for certification period for medical devices in accordance with MDR - Fimea.fi - Fimea

MD Regulation: Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

IVD Regulation: Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices