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Medical UKCA Certification

Medical UKCA Certification

Medical UKCA - Marking

DEKRA ISO13485 surgery medical devices

In order to use UKCA-marking on their medical devices, manufacturers must ensure conformity to the UK Medical Device Regulation 2002 as amended.

CE marking will still be recognised by the UK for medical products until July 1, 2023. From this date onwards, manufacturers that want to (continue to) place their products on the UK market need to comply with the UK MDR 2002. DEKRA is committed to continue its services to customers and has started the process to become a UK Approved Body.

What does that mean for me?

You can no longer place products on the market in the UK without registration with the MHRA (see below).

After 1st July 2023 you must also apply the UKCA mark to products to be placed on the market in Great Britain after successful conformity assessment, either self-declared or after third-party assessment by a UK notified body.

What do I need to do?

You must register all products on the MHRA website DORS with the exception of class 1 devices, which must be registered by 1st January 2022.

From 1st July 2023 you must apply UKCA-marking to your products after successful conformity assessment.

Manufacturers outside of the UK must appoint a UK responsible person. (The UK equivalent of an Authorised Representative).

What do I need to comply to?

UKCA is currently based on the UK Medical Device Regulation 2002 as amended (UK MDR 2002). This legislation is the transposition of the 90/385/EEC on Active Implantable Medical Devices and 93/42/EEC on Medical Devices and 98/79/EC on vitro diagnostic medical device directive into UK law and their subsequence modification through implementation of Statutory Instruments. This means the conformity route is based on the same foundation as that previously used in the EU.

Already, considerable changes have been implemented relating to legislation around, for example, virtual manufacturers.

The UK MDR 2002 is under consultation and will undergo change to further diverge from the EU in the next few years.

My products are already CE Certified to MDR/IVDR, will I need to start the process again for UKCA?

If you already have CE Certification with a DEKRA Notified Body you can use this certificate as evidence of meeting the UKCA Certification requirements, once DEKRA is designated as a UK Approved Body. We will only assess the gaps between the legislation under which your CE Certification conformity assessment was performed and the UKCA requirements.

Assessment will be made on the additional/divergent material in the UK MDR 2002 and, where possible, will be integrated into your existing certification cycle.

I am an existing DEKRA client how do I apply for UKCA?

Please contact your regional sales teams to discuss certification using the below contact link or go directly to the UK office at certification.uk@dekra.com

I am a new client interested in becoming a customer of DEKRA how do I apply for UKCA?

Please contact us at certification.uk@dekra.com or using the below link

Contact

DEKRA Certification UK Limited 

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+44 330 9120 368
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