Journey

Selling medical devices in both GB and Northern Ireland

How to achieve dual-market access for medical devices across Great Britain and Northern Ireland. Covers the different regulatory frameworks, marking options, conformity assessment routes, and representative requirements for cross-border compliance.

Manufacturing & Engineering Updated 15 September 2026
6 milestones references 5 guides

  1. Understand the two regulatory frameworks

    Placing medical devices on the Northern Ireland market

  2. Choose your marking strategy

    UKCA and CE marking for medical devices

  3. Select your conformity assessment bodies

    Choosing a UK Approved Body for medical devices

  4. Appoint your representatives

  5. Register in both markets

    Medical devices: placing on the GB market

  6. Maintain dual compliance

    Post-market surveillance for medical devices

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