UKCA (UK Conformity Assessed) is the Great Britain marking that replaced CE marking after Brexit for products placed on the GB market, including medical devices regulated under the UK Medical Devices Regulations 2002 (as amended). Northern Ireland continues to follow EU rules under the Windsor Framework, so a manufacturer selling across the UK typically manages UKCA for GB and CE/UKNI for NI in parallel. MHRA has extended recognition of valid CE-marked devices on a staged basis, so most manufacturers are running UKCA and CE evidence side by side rather than switching outright.

Practically, UKCA means: a UK Approved Body conformity assessment for anything above the lowest risk class, a UK Responsible Person if the manufacturer is outside the UK, MHRA device registration, and a technical file that stands up to the same scrutiny as an EU MDR file — clinical evaluation, risk management to ISO 14971, usability, post-market surveillance and vigilance reporting to the MHRA.

The underlying quality system is the shared asset. An ISO 13485 QMS that satisfies a UK Approved Body is the same system that satisfies an EU Notified Body and, with the QMSR harmonisation, FDA. V5 Ultimate maintains one controlled document set, one training matrix and one eDHR stream, then produces the evidence pack per market — so UKCA does not become a duplicate quality system. See ISO 13485 software and medical device eDHR software.

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