MedTech Terms
    The authoritative reference
    All terms

    MHRA / UKCA Marking

    UK regulator and post-Brexit conformity marking for medical devices in Great Britain.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    The Medicines and Healthcare products Regulatory Agency (MHRA) regulates devices in Great Britain under the UK MDR 2002 (as amended). UKCA marking will replace CE marking for the GB market on a transition timeline currently extended through 2030 for many device classes.

    What this means in practice

    Northern Ireland continues to follow EU rules under the Windsor Framework, requiring CE/UKNI marks. UK Approved Bodies - separate from EU Notified Bodies - perform conformity assessments for UKCA.

    Cross-references

    Often confused with

    Distinct concept frequently mistaken for this one.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    MHRA·1RAPS·1FDA·1
    1. 1
      MHRA Medical Devices
      Verified
      MHRAgov.uk
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.