UKCA Marking Deadlines and CE Mark Recognition
Transition timelines for medical device conformity marking in Great Britain
- CE marking recognition (medical devices)
- Until 30 June 2028
- CE marking recognition (IVDs)
- Until 30 June 2030
- UKCA mandatory from
- 1 July 2028 (medical devices) / 1 July 2030 (IVDs)
- Northern Ireland
- CE marking required (UKCA alone not valid)
- UK Approved Body requirement
- Class IIa, IIb, III devices
- Class I devices
- Self-certification by manufacturer
- MHRA consultation (2025)
- Proposal for indefinite CE mark recognition under consideration
Key dates: The MHRA has extended recognition of CE marked medical devices in Great Britain. Devices with valid CE certification under EU MDR/IVDR will be accepted until 30 June 2028 (general medical devices) or 30 June 2030 (IVDs), whichever is earlier if certificate expires. The MHRA is consulting on potentially making CE mark recognition indefinite.
Northern Ireland: Due to the NI Protocol, devices must bear a CE mark to be placed on the NI market. UKCA marking alone is not sufficient for Northern Ireland.