The Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognize European CE Marking in Great Britain until between 2028-2030, depending on the type of CE Marking. This is part of their transitional arrangements, to ensure the continued supply of devices in the UK.
After the above date, manufacturers must obtain UK Conformity Assessed (UKCA) Marking, in order to have continued access to the Great Britain markets: England, Scotland, Wales.
Northern Ireland, the fourth UK country, is still part of the European Single Market. As such, it requires CE Marking and will not recognize UKCA Marking.
What is UKCA marking?
Once the UK left the European Union (“Brexit”), the MHRA developed its own conformity assessment process: UKCA Marking.
Like European CE Marking, the UKCA Marking requires that devices (other than lowest risk, which are self-certified), obtain a conformity assessment certificate issued by an accredited body. In the UK these are called Approved Bodies and are similar in concept to an EU Notified Body.
The list of UK Approved Bodies can be found: HERE
What are the UKCA Marking requirements?
The UK left the EU before the MDR/IVDR dates of application. Therefore, the UK medical device regulation (UK MDR 2002 (SI 2002 No 618, as amended)) is currently based on the old Directives – MDD/AIMDD/IVDD.
As a result, an MDD/IVDD compliant technical documentation file in general meets UKCA Marking requirements, except for gaps such as appointing a UK Responsible Person instead of an EU Authorized Representative, and of course, referencing the UK legislation throughout instead of the EU Directives/Regulations.
Future changes to the UKCA marking requirements?
The MHRA is in the process of updating its legislation and the new regulation is expected to go into effect in early 2026. Many of the proposed revisions align with the MDR/IVDR, including up-classification of certain devices.
The MHRA also intends to introduce an International Reliance process, allowing companies to leverage their FDA clearance, Health Canada license, EU certification, and Australia certification, for qualifying devices.
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What is the deadline to UKCA Mark?
First, we need to make a distinction between the four countries that make up the UK: England, Northern Ireland, Scotland and Wales. The requirements in England, Scotland and Wales (collectively “Great Britain”) differ from Northern Ireland.
Great Britain has a transition period in place, which allows companies to market devices based on their CE marking until:
MDR/IVDR/IVDD CE Marked Devices:
- the CE certificate expires; or,
- 30 June 2030, whichever is sooner
MDD/AIMDD CE Marked Devices:
- the certificate expires; or,
- 30 June 2028, whichever is sooner
The current UK medical device and IVD regulation is based on the old EU Directives. A new, more robust UK regulation is expected to go into effect in early 2026.
After these dates, companies must either have UKCA Marking or International Reliance authorization in order to continue marketing in Great Britain. The International Reliance program allows companies to continue to leverage their CE Marking; however, it will not be at the same “face value” as it is accepted today.
To learn more about the above, please read: New Dates for UK Regulation & CE Marking and MHRA Opens Public Consultation on International Reliance Framework
Northern Ireland currently requires, and will continue to require, European CE marking in order place devices onto its market.
Registration Requirements
The above CE marking transition period does not exempt companies from appointing a UK Responsible Person (non-UK manufacturers only) and registering their devices with the MHRA (all manufacturers). Manufacturers must appoint a UK Responsible Person and register its devices with the MHRA before they begin marketing activities.
What is the earliest I can UKCA Mark my device?
Companies can voluntarily start the UKCA marking process at any time.
Between now and when the CE marking transition period ends (see dates above), the MHRA continues to allow companies to place their devices onto Great Britain based on CE marking. However, UKCA marking is also accepted during this time.
