EU MDR vs UKCA: Europe and UK Medical Device Regulation Post-Brexit
Compare EU MDR CE marking with UK UKCA marking — diverging requirements, transition deadlines, dual-market strategies, and Notified Body vs UK Approved Body.
EMA
European Medicines Agency
European Union
The EMA coordinates the EU regulatory framework for medical devices under EU MDR 2017/745 and IVDR 2017/746. While Notified Bodies conduct conformity assessments, the EMA and European Commission set p…
Class I, IIa, IIb, III
CE marking via Notified Body
- ▸EU MDR / IVDR framework coordination
- ▸EUDAMED database oversight
- ▸Notified Body designation support
- ▸CE marking pathway
- ▸Vigilance and post-market surveillance
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 devel…
Class I, IIa, IIb, III
UKCA marking via UK Approved Body
- ▸UKCA marking
- ▸UK device registration
- ▸Yellow Card adverse event reporting
- ▸UK Approved Body oversight
MedFlux monitors both EMA and MHRA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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