The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). The new arrangements recognise the challenges in capacity across notified bodies. Key changes include:
Extension of 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 post-market surveillance, quality management systems, and engagement with notified bodies).
Extension of the transitional period for medium and lower-risk devices (other class 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 post-market surveillance, quality management systems, and engagement with notified bodies).
These changes to the EU MDR apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol.
The EU has also extended the validity of certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC that were issued from 25 May 2017 and were still valid on 26 May 2021. This extension to the end of the relevant transition period set out above (being 31 December 2027 or 31 December 2028 depending on device class) applies to:
Certificates that expired before 20 March 2023 subject to meeting one of the conditions set out in the amendments to the EU MDR.
Certificates that were due to expire after 19 March 2023 so that they now expire at the end of the relevant transition period.
These extensions apply automatically in Northern Ireland. Certificates that have been extended will also be recognised as valid for placing CE marked devices on the GB market.
The MHRA will update their registrations guidance to reflect this change.
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 these changes which will help mitigate the risk of shortages of medical devices available on the market. We know that the medical device industry has had concerns about the expiry of certificates. We have been working with them to grant exceptional use authorisations where there is a public health need. We welcome the EU changes to renewals which will mean for many manufacturers supply to the UK can continue without the need for an exceptional use authorisation.
Text kindly reproduced from the UK's MHRA's press release