Please note that some services are not available in conjunction with UK Approved Body services for medical devices. Please contact us for more information.
For many products placed onto the GB market, a CE mark can be used to demonstrate compliance with UK market requirements.
However, some products will require a UKCA mark and where differences exist between UK and EU legislation, a UKCA mark may be mandatory.
Expert Services from Eurofins Electrical & Electronics in the UK can provide compliance support services to ensure that your products are correctly marked and that the documentation, labelling and information provided allows your products to be placed onto the market.
The UKCA (UK Conformity Assessed) mark is a product conformity mark that can be used for specific products being placed on the market in Great Britain (England, Wales and Scotland).
The UKCA mark will not be recognised outside of Great Britain, and products will still need to bear a CE mark to be sold in the EU. The Ireland/Northern Ireland Protocol means that products placed on the Northern Ireland market will continue to meet relevant EU rules, including CE marking.
The UKCA Mark can be used to show that a product meets the conformity requirements for the GB market. However, on the 1st of August, 2023, the UK government announced plans to extend recognition of CE marking ‘indefinitely’ beyond the upcoming December 2024 deadline previously announced.
The announcement made was:
This means businesses can use the UKCA (UK Conformity Assessed) or CE marking to sell products in Great Britain (GB). Continued recognition of current EU requirements, including the CE and reversed epsilon markings, will apply to 21 product Regulations listed below.
This will include the 18 product regulations under the Department for Business and Trade (DBT) remit, plus three additional regulations.
The DBT regulations in the scope of the announcement are:
For the Department for Environment, Food and Rural Affairs (Defra):
For the Department for Energy Security and Net Zero (DESNZ):
For the Department for Work and Pensions (DWP) (Health and Safety Executive (HSE)):
Medical Devices fall under the remit of the MHRA (Medicines and Healthcare Products Regulatory Agency), and a different regulatory regime is in place for these products.
Full details of the current regime can be found here
Eurofins Electrical & Electronics can provide UKCA marking for Medical Devices. Please contact your local Eurofins Electrical & Electronics team for details on the available services.
Connect with our experts today and find out how UKCA marking can help your product meet the UK's requirements for conformity.