UK Medical Device Regulators to Accept Extended EU Certificates

By Karen Hill

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that medical device certificates that have been extended in the European Union (EU) by Regulation (EU) 2023/607 (amendment to EU MDR) will also be recognized as valid for placing CE marked devices on the Great Britain (GB) market.

The announcement confirms that CE certificates issued by Notified Bodies under Directives 90/385/EEC and 93/42/EEC that were issued from May 25, 2017 and were still valid on May 26, 2021, extended to either December 31, 2027 (for Class III and certain Class IIb implantable devices) or December 31, 2028 (for other Class IIb, Class IIa, Class Im, Is and Ir devices), subject to certain conditions by Regulation 2023/607, will also be accepted as valid in the GB market.

Furthermore, this extension also applies to CE certificates that expired before March 20, 2023, subject to their meeting one of the conditions set out in the EU amendment. Certificates that were due to expire after March 19, 2023 will now expire at the end of the relevant transition period.

The announcement also confirms that these extensions will apply automatically in Northern Ireland.

Emergo by UL consultants in the UK and Europe will provide additional updates on UK medical device and in vitro diagnostic (IVD) regulatory changes as they become available.