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UKCA Marking for Medical Devices

DEKRA is now a UK Approved body

With the United Kingdom (UK) leaving the European Union (EU), changes came into force for manufacturers placing products on the UK market. As of 1 January 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. The regulatory authority for UKCA marking of medical devices is the Medicines and Healthcare Products Agency (MHRA).

CE marking will still be recognised, subject to meeting timelines and requirements mandated by the MHRA and EU, until 2030. Please see the MHRA website for latest information - Medicines and Healthcare products Regulatory Agency - GOV.UK ( www​.gov​.uk ) Once CE marking for a device is no longer valid, manufacturers that want to (continue to) place their products on the UK market need to comply with the new UKCA marking regulation. DEKRA Certification UK Ltd was designation as an MHRA 8505 approved body in September 2022 and therefore can continue its service to existing customers.
All medical devices placed on the market must be registered with the MHRA and manufacturers located in the UK can register their products directly with MHRA. Manufacturers outside the UK will need to appoint a responsible person to register their products. Timelines for registration can be found here .
DEKRA has developed a robust UKCA conformity assessment process which is delivered from our UK legal entity (DEKRA Certification UK Ltd) facilitated by the extensive experience of our two European Notified Bodies and our existing UK network and infrastructure.
DEKRA Certification UK Ltd can perform standalone UKCA conformity assessments or can align UKCA marking conformity assessment activities to an existing cycle of CE marking activities, and integrate them into the certification activities already scheduled, where possible.
Existing customers are encouraged to apply for UKCA certification via their current Project Manager or directly using certification​.uk@​dekra​.com . New customers who wish to apply or require further information can also contact us at certification​.uk@​dekra​.com .
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