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 3rd-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:
Sarah joined BHTA in April 2018.
After graduating with a Masters in English Language from De Montfort University, Sarah works across all BHTA publications (including AT Today and THIIS).