29 March 2023
The MHRA has announced that it will recognise the EU extension of both transition times and certificates for medical devices in Great Britain and Northern Ireland.
The MHRA states that the recently published EU 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”.
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”.