How is medical device regulation structured in the UK post-Brexit?
The UK uses UKCA (UK Conformity Assessed) marking overseen by the MHRA, replacing the EU CE marking system (though CE marks remain recognised during transition). Devices are classified into Class I, IIa, IIb, and III based on risk, with clinical evidence requirements increasing with classification. UKCA marking is mandatory for the GB market from 2025 for higher-risk devices, with post-market surveillance obligations for all classes.