The Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognize European CE marking in Great Britain between 2026-2028, 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 that 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. The UK designated their own conformity assessment bodies, who are authorized to issue UKCA marking certificates. These are called Approved Bodies and are similar in concept to a Notified Body.
The list of UK approved bodies can be found here.
The UK left the EU before the Medical Devices Regulation (MDR)/In Vitro Diagnostic Devices Regulation (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.
However, it is not so simple.
The MHRA is in the process of updating its legislation and the new regulation is expected to go into effect in 2023. Many of the proposed revisions appear to 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.
Northern Ireland will continue to require CE marking. Even though Northern Ireland is part of the UK and has therefore left the European Union, it will not implement or recognize UKCA marking.
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:
- either the CE certificate expires or
- for five years after the new regulations take effect, whichever is sooner
MDD/AIMDD/IVDD CE Marked Devices:
- either the certificate expires or
- for 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 and a new version of the UK regulation has been proposed. The updated UK regulation will be similar to the MDR/IVDR and is expected to go into effect in 2023, Therefore, the MDR/IVDR five-year extension is to 2028, the MDD/AIMDD extension is to 2026 and the IVDD extension is to 2028.
After these dates, companies must have UKCA marking to continue marketing in Great Britain.
Northern Ireland currently requires, and will continue to require, European CE marking in order place devices onto its market. However, companies will also need to meet certain additional UK requirements to continue selling in both Great Britain and Northern Ireland. For example, appointment of a UKRP and registration with the MHRA may still be required for Northern Ireland in some situations, in addition to CE marking.