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.

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

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.

The MHRA is in the process of updating its legislation and the new regulation is expected to go into effect in 2025.

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. 

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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 July 2025. 

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: New Dates for UK Regulation & CE Marking

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.

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.