UK medical device compliance, UKCA, MHRA & SaMD

If your product diagnoses, prevents, monitors, predicts, treats or alleviates a disease, injury or disability, or supports a clinical decision that does, it is likely Software as a Medical Device (SaMD) and needs to be classified, registered with the MHRA and UKCA-marked.

UKCA is the UK conformity mark for medical devices placed on the Great Britain market. It replaces CE marking for GB and requires demonstrating compliance with UK MDR 2002 (as amended).

Yes. Manufacturers of medical devices placed on the GB market must register with the MHRA. A UK Responsible Person is required if the manufacturer is based outside the UK.

They are separate regimes but overlap. DCB0129 covers clinical safety of Health IT in NHS use; UK MDR / UKCA covers safety and performance of the device itself. Most NHS-facing SaMD needs both.

We work with trusted UKRP partners and coordinate the whole pathway, classification, technical file, QMS, UKRP, MHRA registration and post-market surveillance, so you have one team end-to-end.