Journey

Placing a medical device on the GB market

End-to-end learning path for manufacturers bringing a medical device to the Great Britain market for the first time. Covers pre-market steps (classification, conformity assessment, marking, registration) and post-market obligations (surveillance, vigilance reporting).

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

  1. Classify your device

    Classify your medical device for the GB market

  2. Choose your marking route

    UKCA and CE marking for medical devices

  3. Engage a UK Approved Body (if required)

    Choosing a UK Approved Body for medical devices

  4. Register with MHRA

    Medical devices: placing on the GB market

  5. Set up post-market surveillance

    Post-market surveillance for medical devices

  6. Understand vigilance reporting

    Report a medical device safety incident to MHRA

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