Medical UKCA Certification
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, 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 Once CE marking for a device is no longer valid manufacturers that want to (continue) placing their products on the UK market need to comply with the new UKCA marking regulation.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 provide this service to customers.
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 the date that a CE mark is no longer recognised as valid for placement on the UK market (subject to meeting timelines and requirements mandated by the MHRA and EU, please see the MHRA website for latest information) you must 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 Approved Body.
What do I need to do?
You must register all medical devices (including 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 (The UK equivalent of an Authorised Representative) who assumes the responsibilities of the manufacturer in terms of registering the device with the MHRA.
After the date that a CE mark is no longer recognised as valid for placement on the UK market (subject to meeting timelines and requirements mandated by the MHRA and EU, please see the MHRA website for latest information) if the medical device you manufacture requires a third-party assessment under the UK MDR, you need to obtain the services of a UK Approved Body such as DEKRA in order to obtain a UKCA mark. More information on the conformity assessment required and routes to UKCA marking can be found
here.
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 regulations are in a state of change with new regulations set to be released in 2023. This information was correct at the time of publishing however we recommend manufacturers check the most recent updates on the .gov website.
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. 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