DEKRA Product Testing
How to assess medical devices for conformity with British regulation?
UKCA Marking
For compliance with the MDR 2002
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 read the MHRA website for latest information​.
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.
DEKRA is committed to continue its services to customers and has started the process to become a UK Approved Body.
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.
Why choose DEKRA?
DEKRA Certification UK Ltd is a designated UK Approved body (8505) supported by a global network of medical experts allowing for DEKRA's one-stop approach to medical service delivery.
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.
Indien u momenteel geldige CE-certificering heeft, maakt ons verkorte proces het mogelijk om de bestaande certificering te gebruiken als bewijs van het voldoen aan enkele van de vereisten voor UKCA, indien mogelijk. Neem voor meer informatie contact op met
certification​.uk@​dekra​.com
.