The UKCA Marking Process and Deadlines
The Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognize European CE marking in Great Britain until between 2027-2029, 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 to have continued access to the Great Britain markets: England, Scotland, Wales.
What is UKCA marking?
Once the UK left the European Union via 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 current UKCA marking requirements?
The UK left the EU before the MDR/IVDR dates of application. Therefore, the UK medical device regulation is currently based on the old Directives – MDD/AIMD/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.
What changes are expected to UKCA marking requirements?
The MHRA is in the process of updating its legislation and the new regulation is expected to go into effect in 2024.
Many of the proposed revisions align with the MDR/IVDR, including appointment of a Quality Person (similar to an EU Person Responsible for Regulatory Compliance (PRRC)); requirement for liability insurance; up-classification of certain devices; and overall increased scrutiny.
When is the deadline to UKCA mark medical devices & IVDs?
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 CE Marked Devices:
- the CE certificate expires; or,
- five years after the new regulations take effect, whichever is sooner
MDD/AIMDD/IVDD CE Marked Devices:
- the certificate expires; or,
- three years (for general medical devices) and five years (for IVDs) after the new regulations take effect, 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 July 2024. If the July 2024 timeframe is met, then the five-year MDR/IVDR CE marking extension is to July 2029, the three-year MDD/AIMDD CE marking extension is to July 2027 and the five-year IVDD CE marking extension is to July 2029.
After these dates, companies must have UKCA marking to continue marketing in Great Britain.
To learn more about the UKCA / CE Marking transition period, please read: UKCA Marking Postponed & CE Marking Transition Period Extended
Northern Ireland currently requires, and will continue to require, European CE marking in order place devices onto its market.
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). The transition period for UK Responsible Person and registration ended as of 1 January 2022.
When is the earliest I can start UKCA marking my devices?
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. After the transition period ends, then UKCA marking becomes mandatory.
Have additional questions? Check out our: UKCA Marking Fact Sheet