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§ EUROPE
MHRA
Medicines and Healthcare products Regulatory Agency
United Kingdom
Post-Brexit, the MHRA operates an independent regulatory framework for medical devices in the UK. The UK Conformity Assessed (UKCA) marking is replacing CE marking for the UK market. The MHRA is developing its own device regulation framework distinct from EU MDR.
DEVICE CLASSES
Class I, IIa, IIb, III
APPROVAL PATHWAY
UKCA marking via UK Approved Body
KEY REGULATORY FUNCTIONS
- ▸UKCA marking
- ▸UK device registration
- ▸Yellow Card adverse event reporting
- ▸UK Approved Body oversight
OFFICIAL WEBSITE
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency →MedFlux monitors MHRA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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