MHRA Suggests Approving Medical Devices with Foreign Certification

Brexit forced MHRA to reconsider its healthcare device approval process. Prior to Brexit, businesses utilised CE certifications, which are applicable throughout the EU, for selling medical products in the UK.

The MHRA suggests in the report that agencies in the US, Australia, Canada, and the EU be treated as equivalent organisations. Given that the MHRA and the Pharmaceuticals and Medical Devices Agency are having “active discussions” over the allowance of Japanese medical equipment approvals, the list may get longer.

Following “a declaration by the manufacturer to an appropriate quality management system,” the MHRA intends to permit the commercial release of a few Class I gadgets and Class A diagnostics. The entrance hurdle for producers of medical equipment with greater risks will be easier than if they pursued a UKCA mark, even with the requirement for them to offer additional details.

MHRA stated it “will retain the authority to reject applications if the evidence provided is considered insufficiently robust.”