Milestone 2 of 6 Selling medical devices in both GB and Northern Ireland

Step 2: Choose your marking strategy

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.