Medical UKCA Certification

UKCA marking came in to force when the UK left the European Union and is placed on medical devices to show conformity to the Medical Device Regulation (MDR 2002 as amended) .

CE marking is currently still recognised in Great Britain subject to meeting timelines and requirements mandated by the MHRA and EU. Please see the MHRA website for latest information -

Medicines and Healthcare products Regulatory Agency - GOV.UK (www.gov.uk).

Once CE marked devices are no longer accepted on the UK market, manufacturers that want to place their products on the UK market need to comply with the new UKCA marking regulation.

What do I need to do?

You must register all medical devices and IVDs with the MHRA, regardless of class. More information can be found on the MHRA website here.
Manufacturers based outside of the UK must appoint a UK Responsible Person who assumes the responsibilities of the manufacturer.
You need to classify your device in order to identify the appropriate conformity assessment route. You must apply the UKCA mark to products to be placed on the market in Great Britain after successful conformity assessment. Depending on the class of device, this can either self-declared or after third-party assessment by a UK Approved Body such as DEKRA.

UK Regulations

The UK regulations are in a state of change and all information was correct at the time of publishing. We recommend manufacturers to check the most recent updates available on the GOV.uk website. Some useful links can be found below.

Using the UKCA marking GOV.UK

Placing manufactured goods on the market in Great Britain GOV.UK

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

If you currently have valid CE certification, our abridged process allows the existing certification to be leveraged as evidence of meeting some of the requirements for UKCA where possible. Please contact certification.uk@dekra.com for more information.

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

Please contact your regional team to discuss UKCA certification. Your project manager or sales manager will contact you when you can submit your application.

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 by using the link below.