Journey Step 2 of 6

Step 2: Choose your marking strategy

Step 2 of 6

Common dual-market strategies:

  • CE marking only (during transition): Simplest route. CE mark is valid for NI (permanently) and GB (until 2028/2030 deadlines). Risk: GB deadline may not be extended.
  • CE + UKCA dual marking: Most robust. CE from EU Notified Body for NI, UKCA from UK Approved Body for permanent GB access. Two conformity assessments required.
  • CE + UKNI from UK Approved Body: UK Approved Body issues CE + UKNI marking for NI market. Combine with separate UKCA for GB. Note: UKNI not valid in EU.

UKCA and CE marking for medical devices

How to choose between UKCA and CE marking for your medical device on the GB market. Covers UKCA marking via UK Approved Bodies, CE marking transitional acceptance (2028/2030 deadlines), the MHRA consultation on indefinite CE recognition, dual marking for GB and NI access, and NI-specific requirements.

Read the guide →