UK Medical Device Manufacturers Prepare for Post-Brexit Regulations
LONDON–On January 1, 2021, new regulations by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK (England, Scotland, and Wales) will require medical devices of all classes to be registered with the agency. These regulations may impact the number of approved medical devices in the future.
Manufacturers will be given a grace period of four to 12 months to comply with the new registration process, depending on the risk of the device, Higher-risk devices require an earlier registration. Manufacturers based outside the UK will need to appoint a UK Responsible Person to register devices with the MHRA in line with the grace periods.