The Medicines and Healthcare products Regulatory Agency (MHRA), the UK Competent Authority, has updated its guidance on withdrawal of notified body services.
After several notified bodies based in the UK withdrew their services in view of Brexit, many manufacturers feared that they might not be able to find a new notified body within a short time and that they might lose their CE mark.
Currently, there are no specific provisions regarding the validity of CE certificates in these situations. Therefore, on January 29th 2020, the MHRA announced it will grant a grace period to medical device manufacturers affected by the withdrawal of a notified body. This will allow them to continue placing their products on the EU market until they can finalize the switch to a new notified body.
Who can benefit from the grace period?
The support of the MHRA will be granted to manufacturers holding a valid CE certificate under the Directives 93/42/EC, 98/79/EC and 90/385/EC, who are either based in the UK or outside the UK, who have an authorized representative based in the UK, and whose notified body will close or reduce its scope.
What are the conditions to be eligible?
The Agency said it will decide whether to offer the grace period on a case-by-case basis and only if some conditions are met:
· The manufacturer must submit regular updates to the MHRA to allow it to check the
progress made in finding a new notified body and the status of CE certification. If the conditions are not met, the grace period will be ended. The permission might also be ended if the MHRA finds evidence that the devices are falling short of safety requirements.
· The agency also warns that its support will not replace the activities of a notified body and will not be granted to manufacturers who cannot transition their certificates from Directives 93/42/EC, 98/79/EC and 90/385/EC to the Regulations 2017/745 (EU Medical Devices Regulation) and 2017/246 (In Vitro Diagnostic Regulation).
For more information, contact our Obelis experts today, and please have a look at the MHRA Guidance here.
Regulatory Affairs Department