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Medical UKCA Certification

UKCA - Marking  

The route to market for high risk products in the UK has changed. As of January 1, 2021, a new conformity assessment marking scheme - called UK Conformity Assessed (UKCA) marking - was launched in Great Britain (England, Wales and Scotland) in place of the CE mark.

DEKRA UKCA Marking

DEKRA UK is applying to become a UK Approved Body for the following product areas:

  • Machinery

  • Equipment for use outdoors

  • Personal Protective Equipment

  • Explosion Safety (UKEX)

CE-marking continues to be recognised in Northern Ireland.

As only designated UK Approved Bodies (UKABs) can issue UKCA Certificates and only EU Notified Bodies can issue CE Certificates, part of the Northern Ireland Protocol allows UKABs to issue a form of CE only for use in Northern Ireland. This CE mark must be accompanied by the UKNI mark.

UKCA-marking will be required on all products entering the GB market from 1st January 2022, except for medical devices and in vitro diagnostic medical devices.

For these products the transition period is longer and UKCA-marking is mandatory from 1st July 2023. At this point the current CE-marking will no longer be recognised.

Manufacturers may already use UKCA-marking as a route to market in Great Britain.

DEKRA is committed to become a UK Approved body for the issuance of UKCA certification for all existing and new clients worldwide.

For more information about UKCA Certification contact us today.

Contact

DEKRA Certification UK Limited 

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+44 330 9120 368
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