| Guvnor

Your marking strategy determines which markets your device can access. Consider CE marking (valid for NI, and recognised in GB on a long-term basis), UKCA marking (GB only), or dual marking.

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)

Common dual-market strategies:

CE marking only: Simplest route. A CE mark is valid for NI, and the government confirmed on 21 October 2026 that it will keep accepting CE marked devices in GB on a long-term basis.
CE + UKCA dual marking: Widest coverage. CE from EU Notified Body for NI, UKCA from UK Approved Body for the GB domestic route. Two conformity assessments required.
CE + UKNI from UK notified body: A UK notified body issues CE + UKNI marking for NI market. Combine with separate UKCA for GB. Note: UKNI not valid in EU.

Step 2: Choose your marking strategy

UKCA and CE marking for medical devices