The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation ("EU MDR"). The proposal recognises the challenges in capacity across notified bodies.
Key changes include:
- Extend the transitional period for higher-risk devices (class III and certain class IIb implantables) such as pacemakers to comply with EU MDR requirements until 31 December 2027, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with notified bodies).
- Extend the transitional period for medium and lower-risk devices (other lass IIb devices, class IIa, class Im, Is and Ir devices) such as syringes to comply with EU MDR requirements until 31 December 2028, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with notified bodies).
- Extend the validity of certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC that were valid on 26 May 2021. Subject to meeting specific conditions, this extension also applies to those certificates that expired before the amendments took effect.
These changes made to the EU MDR will apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol.
The MHRA is working to consider carefully what the implications of these revisions are for acceptance of CE marked medical devices on the Great Britain (GB) market. At present, a device with a valid CE mark can be placed on the GB market until 30 June 2023. That includes certificates valid under the latest EU's revised transitional arrangements. As announced in October 2022, there are plans to extend acceptance of the CE marking in GB which we will put into law in the coming months. We will publish guidance on this as soon as possible.
Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer, said:
"Our priority is ensuring that patients have safe access to medical devices, and we welcome the Commission's proposal which will help mitigate the risk of shortages of medical devices available on the market.
"We know that the medical device industry views the United Kingdom as a global growth market, and is looking to the MHRA for our leading regulatory expertise to provide pragmatic guidance at this time."
"The MHRA has an exceptional use authorisation (EUA) process in place, that enables devices to be placed on the market in limited circumstances, when they do not have a valid CE or UKCA mark, including where those marks have expired. In addition to our transition provisions, we are using this process to ensure continued supply to UK patients, where there is a clear public health need."
