UKCA Marking
UKCA — UK Conformity Assessed — is Great Britain's post-Brexit conformity marking for medical devices, administered under MHRA-regulated rules alongside a long transition during which CE-marked devices remain accepted.
What is the UKCA mark?
UKCA is a conformity marking available for medical devices placed on the Great Britain market under the UK Medical Devices Regulations 2002, as amended. A UK Approved Body performs conformity assessment where the applicable route requires third-party involvement. The MHRA's current guidance on regulating medical devices in the UK is the operating reference. UKCA is not recognized in Northern Ireland, where EU device rules and CE marking, with CE UKNI where applicable, govern market access.
Do I need UKCA now, or is CE still accepted?
CE-marked devices remain accepted in Great Britain under transitional arrangements. EU MDR- and IVDR-compliant devices may be placed on the GB market until 30 June 2030. General medical devices relying on valid MDD or AIMDD conformity may be accepted until the earlier of certificate expiry or 30 June 2028, while IVDD-compliant IVDs have a separate deadline of the earlier of certificate expiry or 30 June 2030. Eligibility conditions and later policy changes still matter, so manufacturers should verify the current MHRA position for the specific device.
What does a GB market entry require besides the marking?
Devices must be registered with the MHRA before being placed on the GB market. A manufacturer established outside the UK must appoint a UK Responsible Person to perform specified tasks, including registration. Label rules differ by conformity route: UK Responsible Person details are required on the labeling, outer packaging or instructions for use when UKCA is affixed, but the MHRA does not currently require those details on a CE-only device unless it also bears UKCA.
How should a manufacturer sequence EU and UK compliance?
A manufacturer can currently use a valid CE route during the applicable GB recognition period or pursue UKCA under the UK framework. The decision should account for device type, certificate validity, Approved Body capacity and the evolving UK regime rather than assume one universal sequence. The United Kingdom market page covers registration, representation and current route mechanics together.
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