UK Allows Grace Period for Unexpected Notified Body Withdrawals

Certain device manufacturers will be allowed to continue placing their products on the EU market while they deal with the sudden withdrawal of a notified body, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced.

The agency will determine which devicemakers are eligible on a case-by-case basis, but said that it expects interested device manufacturers to provide regular updates on their progress in transferring to a new notified body when their previous certifier unexpectedly withdraws.

 “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,” the agency said.