MHRA have confirmed that the timeline extensions for the EU MDR will apply in Northern Ireland, and certificates that have been extended will be recognised as valid for placing CE marked devices on the Great Britain market.
This comes after the EU passed an amendment to the EU MDR and EU IVDR to amend the transition timelines for medical devices, and remove the sell-off provision for IVDs.
MHRA’s statement does not mention IVDs, so it is currently unclear as to whether the sell-off provision still applies for products placed on the market in Northern Ireland.
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.”