Decide whether to apply UKCA marking or use a CE marking that Great Britain accepts. The government said on 21 October 2026 that it will accept CE marked devices on a long-term basis. Your choice affects which assessment body you engage.
UKCA vs CE marking requirements
Comparison of UKCA and CE marking requirements for medical devices in the UK.
- Great Britain (England, Scotland, Wales)
- UKCA marking required (CE marking accepted during transitional period)
- Northern Ireland
- CE marking required under Windsor Framework (UKCA alone NOT valid)
- CE mark deadline — old Directives (MDD/AIMDD/IVDD)
- 30 June 2028
- CE mark deadline — EU MDR/IVDR certified
- 30 June 2030
- Dual marking
- Products can carry both UKCA and CE marks simultaneously
- Indefinite CE recognition consultation
- MHRA consulting on removing 2028/2030 deadlines entirely (16 February to 10 April 2026)
- UKNI marking (Northern Ireland)
- Required alongside CE mark when UK Approved Body has been used for NI market conformity assessment
Using the UKCA marking (opens in a new tab)