Can I sell my Medical AI in the UK after Brexit?
Holding a CE mark doesn't by itself complete UK market access. Great Britain currently accepts CE-marked devices under extended timelines, but you must appoint a UK Responsible Person and register with the MHRA — and Northern Ireland follows different rules.
Run this assessment free →The Great Britain route
CE marking is currently accepted for the GB market under extended timelines, with UKCA as the parallel UK conformity mark. The acceptance window has specific end dates by device type, so verify where your device sits and plan a UKCA transition ahead of that date rather than being caught without it.
UK Responsible Person and registration
A manufacturer based outside the UK must appoint a UK Responsible Person and register the device with the MHRA. This applies regardless of CE status — it's an additional, non-optional step for UK access.
Northern Ireland is different
Northern Ireland follows EU MDR, using CE or UKNI marking. It is a distinct route from Great Britain, and treating the two as the same is a common and costly error. Determine the NI position separately.