MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said Wednesday that in some circumstances when a notified body withdraws its services, the agency will allow a grace period for medical device manufacturers to continue to place their products on the EU market until they find a new notified body.“The offer is dependent on you meeting a number of conditions. This includes regular updates from you to enable MHRA to monitor progress made in transferring to a new notified body and status of CE certification. During the grace period if you fail to keep to the conditions, or if there is evidence of the devices not meeting the relevant safety requirements, we will withdraw the permission. If you gain CE certification before the end of the grace period, MHRA’s support will end, and you will no longer fall under MHRA’s oversight,” the updated guidance says.
But the agency also warns that this process “does not replace the activities of a notified body and it is not applicable to manufacturers who can’t transition their certificates from Directives 93/42/EC, 98/79/EC and 90/385/EC to Regulations 2017/745 [EU Medical Devices Regulation] and 2017/746 [In Vitro Diagnostic Regulation].”
The guidance comes as London-based Lloyd's Register Quality Assurance said in June that it would withdraw its notified body services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an notified body under MDR or IVDR. Similarly, UL UK said last July that it would no longer operate as a notified body under the device directive and limit its work under the in vitro diagnostic directive (IVDD).
When the scope of a designation of a notified body changes, sometimes at short notice, MHRA explains how the validity of the CE certificates previously issued may be affected.
And although there are no specific provisions under current legislation regarding the ongoing validity of CE certificates in such a scenario, MHRA is creating this process “so that manufacturers can keep placing products on the EU market while they transfer to a new notified body.” The agency says the process is aligned to guidance provided by:
- The European Commission’s “Blue Guide,” 2016/C 272/01
- The Notified Body Operations Group’s (NBOG) Best Practice Guide on ‘Changes of Notified Body’
- A guideline agreed upon at the European Meeting of Competent Authorities (CAMD).
Editor's note: Article updated on 2/4/20 to note that IVDR is Regulation 2017/746, not 2017/246.