The Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued guidance for situations where a notified body withdraws all, or part, of its services in relation to medical devices.
Under current legislation, there are no specific provisions regarding the ongoing validity of CE certificates where a change in a notified body’s designation affects the validity of previously issued CE certificates. This guidance, therefore, implements a process which allows manufacturers to continue placing products on the EU market while they transfer to a new notified body which provides the service that that medical device manufacturer requires. It is aligned to guidance provided by:
- the European Commission (The ‘Blue Guide’, 2016/C 272/01);
- the Notified Body Operations Group’s (NBOG) Best Practice Guide on ‘Changes of Notified Body’; and
- a guideline agreed upon at the European Meeting of Competent Authorities (CAMD).
The new process is only for manufactures based in the UK, or for manufacturers outside the UK with an authorised representative based in the UK, affected by closure or scope reduction of their notified body. Such manufacturers must also have a valid CE certificate under Directives 93/42/EC on medical devices, Directive 98/79/EC on in vitro diagnostic medical devices or Directive 90/385/EC on active implantable medical devices.
If a manufacturer is eligible, the MHRA may offer a grace period where they can continue to place products on the EU market until they find a new notified body. The MHRA have complete discretion as to whether to support a manufacturer with decisions made on a case by case basis and consideration given to whether the manufacturer can meet a number of conditions. These conditions include: providing the MHRA with regular updates on the transfer to a new a new notified body, compliance with applicable safety requirements and providing updates on the status of CE certification. If a manufacturer fails to adhere to the MHRA’s conditions during the grace period, or meet the required safety requirements, the MHRA will withdraw their permission. If a manufacturer gains a CE certificate before the end of the grace period, the MHRA’s support will end and the manufacturer will no longer fall under the MHRA’s oversight.
It must be noted that this process does not replace the activities of a notified body and it is not applicable to manufacturers who cannot transition their certificates from Directives 93/42/EC, 98/79/EC and 90/385/EC to Regulations 2017/745 and 2017/246.