11. How the UKCA mark works

Last Updated on 23/08/2023 by Sarah Sarsby

The UKCA mark has been/is the subject of much change. Until the planned inception of the new UK medical device regime on 01 July 2025, and the entry into force of the UKCA mark for UK market access, CE-marked medical devices with a valid declaration of conformity and/or CE certificate can continue to be placed on the UK market. As well, under the Transitional Arrangements outlined in MHRA’s Apr-23 Statutory Instrument (including Explanatory Notes), under certain circumstances, the CE mark will continue to be accepted until between 2028 and 2030. Please see Sections 2-5 above for more detail, including Section 4 above for more specifics on Transitional Arrangements.

Transitional Arrangements notwithstanding, MHRA encourages all manufacturers to embark on the process of obtaining UKCA marking “as soon as possible.” As outlined in Sections 2-5 above, obtaining a UKCA mark is materially similar to obtaining a CE mark – the main difference being that the Declaration of Conformity (for self-certified Class I devices or general IVDs) or Assessment Certificate (for 3^rd-party assessed Class I Special Function, Class II-and-above device, self-test IVD, IVD included in Annex II list B, or IVD included in Annex II list A) issued by a UK Approved Body (UK AB) rather than an EU Notified Body (EU NB) against the UK MDR 2002 (as amended).

For more information on UKCA marking, please see:

• MHRA – Regulating Medical Devices in the UK – UKCA Mark and UK ABs: This section of MHRA’s device regulation page provides an in-context summary of the UKCA Mark UK ABs
• MHRA – Approved Bodies for Medical Devices: Here MHRA outlines their definition of UK ABs, including their role and function within the UK medical device regulation process
• MHRA – Medical Devices – Conformity Assessment and the UKCA Mark: Detailed guidelines on conformity assessment and the UKCA mark for medical devices in particular (including Assessment Routes, International Standards Compliance, Clinical Investigations (if applicable), the UKCA Mark and NI considerations)
• BEIS – Using UKCA Marking: General guidance on using the UKCA Mark, including logo-type assets