MHRA
Medicines and Healthcare products Regulatory Agency
United Kingdom
Last reviewed 2026-06-21
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 →§ FAQ
What is UKCA marking for medical devices?
UKCA (UK Conformity Assessed) marking is the United Kingdom's post-Brexit replacement for CE marking. Medical devices placed on the UK market will need UKCA marking assessed by a UK Approved Body. The UK has extended CE marking recognition deadlines while its own framework is finalized. UKCA requirements are broadly aligned with EU MDR but have UK-specific adaptations.
What is the MHRA Yellow Card scheme?
The Yellow Card scheme is the UK's system for reporting adverse incidents involving medical devices, medicines, and other healthcare products. Healthcare professionals, patients, and manufacturers can submit reports through the MHRA. It is the UK equivalent of the FDA's MAUDE/AEMS system for medical devices.
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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