The UKCA (UK Conformity Assessed) marking is the new product marking required for medical devices placed on the market in Great Britain (England, Wales, and Scotland) following Brexit. Initially expected to become mandatory in July 2023, the UK Government has since announced multiple extensions and regulatory updates, giving manufacturers more time to prepare. Here’s where things currently stand.
As of the most recent MHRA update in 2023, the government has confirmed that CE marking will continue to be recognised in Great Britain for medical devices until 30 June 2030, provided the devices comply with EU regulations and have valid CE certification.
This transitional arrangement is subject to specific conditions, such as the device being unchanged and still under valid certification from an EU-recognised Notified Body. This extension was introduced under the UK Medical Device Regulations (UK MDR) 2002 (as amended), following a government consultation concluded in 2023.
This extension gives medical device manufacturers extra time to adapt to the upcoming UKCA framework. However, the MHRA has emphasized that this should not delay your transition preparations.
The UKCA mark will eventually become mandatory for placing medical devices on the GB market, and the new UK regulatory framework is being developed to reflect many elements of the EU MDR (2017/745) and IVDR (2017/746), but tailored to the UK context.
| Feature | UKCA | CE |
|---|---|---|
| Market | Great Britain only | EU + Northern Ireland |
| Validity in GB | Valid from 2021, mandatory from 2030 | Accepted until 30 June 2030 |
| Notified/Approved Bodies | UK Approved Bodies | EU Notified Bodies |
| Regulatory Basis | UK MDR (2002, amended) | EU MDR/IVDR |
In Northern Ireland, CE marking (and in some cases, CE + UKNI) remains mandatory due to the Northern Ireland Protocol.
Despite the longer timeline, manufacturers should act now to ensure smooth compliance. Here’s what to do:
If you are based outside the UK and plan to place medical devices on the GB market, you must appoint a UK Responsible Person. This person or entity will:
Register your devices with the MHRA
Ensure documentation and post-market surveillance obligations are met
Liaise with the MHRA on your behalf
All medical devices, IVDs, custom-made devices, and procedure packs must be registered with the MHRA before being placed on the market in GB. Only a UK-based Responsible Person or the manufacturer themselves (if UK-based) can complete this.
UK RepMed can support you with Responsible Person services and device registration. Visit our website for more information.
If your CE certificate expires before 2030 or you intend to make significant changes to your device, you will need to undergo UKCA certification via a UK Approved Body.
The MHRA is expected to publish updated UKCA guidance and statutory instruments in 2025. These updates may clarify timelines, post-market surveillance, UDI requirements, and conformity assessment processes.
UKCA marking is not recognised in the EU or Northern Ireland
UK Notified Bodies have become UK Approved Bodies – they cannot issue CE certificates
Devices must not be substantially changed if relying on the CE transitional period
While the extension to 2030 provides welcome breathing room, it is not a time to pause. Manufacturers should take advantage of this period to:
Finalise UKRP arrangements
Ensure MHRA registration is complete
Develop a transition plan for UKCA marking
Stay informed on MHRA announcements and evolving UK-specific requirements
The UK regulatory landscape is moving steadily towards independence from the EU model. Preparedness now will save resources – and risk – later.