MHRA Statement: Impact of the EU Commission’s MDR Extension in the UK
20 February 2023
Class B/C IVD Deadline to Appoint Swiss Authorized Rep: 31 Mar 2023
1 March 2023Page Last Updated: 5 January 2026
Background
When the UK left the European Union, the EU MDR/IVDR had not yet been implemented into its legislation. Therefore, at the time of its withdrawal from the EU, the prevailing regulations were based on the old European Directives (MDD/AIMDD/IVDD).
The MHRA announced at the time of withdrawal that they would implement their own medical device assessment process (“UKCA Marking”). Further, that they would ‘upgrade’ their current MDD/AIMDD/IVDD-based legislation and introduce more robust legislation.
In the meantime, to avoid a disruption in supply, the UK government put a transition period into place. As part of the transition period, the MHRA will allow CE Marked devices onto the UK market. The deadline to UKCA Mark devices was originally set for 1 July 2023. However, this was later postponed, and a longer transition period to accept CE Marking granted instead.
Information about the new UKCA Marking deadline and new CE Marking transition period can be found: HERE
Current Regulatory State
NOTE: from a regulatory perspective, the UK is made up of two territories: 1) Great Britain (England, Scotland, Wales) and 2) Northern Ireland. Great Britain is expected to require UKCA Marking in the future. However, Northern Ireland currently requires, and will continue to require, European CE Marking. This was arranged under the ‘Brexit’ agreement in order to ensure the movement of goods and people between Northern Ireland (UK country) and Ireland (EU country).
In order to market devices in the Great Britain, manufacturers must:
- Either CE Mark or UKCA Mark their device
- Register their company and devices with the MHRA
- If the manufacturer is not located in the UK, then they must appoint a UK Responsible Person (UKRP), who must complete this registration on the manufacturer’s behalf
CE Marking will be allowed until:
- MDR, IVDR and IVDD CE Marked devices: 30 June 2030 or the CE Certificate expires, whichever is sooner
- MDD and AIMDD CE Marked devices: 30 June 2028 or the CE Certificate expires, whichever is sooner
Currently there are less than 9 UK Approved Bodies designated to issue UKCA Marking certificates. The list of UK Approved Bodies is available: HERE
Future Regulatory State
The MHRA is in the process of updating its legislation and the new regulation is expected to be laid in Parliament sometime in 2026. Many of the proposed revisions align with the MDR/IVDR, including up-classification of certain devices.
The MHRA will have a transition period for companies that already have UKCA Marking under the current regulation, to give them time to meet the new, more rigorous regulation. While the transition timeframe is not yet known, the MHRA previously indicated 3-to-5 years, depending on the type of device.
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.
The MHRA is also considering indefinitely accepting CE Marking in the UK.
Why UKCA Mark, if CE Marking is still accepted?
For most companies, it is logical to continue marketing with their existing EU CE marking.
However, there is an instance in which it may be particularly beneficial to UKCA mark your device in addition to CE Marking. This is related to new devices and the difference in UK and EU device classification.
Device Classification Differences: Great Britain vs EU
The current UKCA marking legislation is based on the MDD/AIMDD/IVDD. This means the classification may be lower in the UK.
In Europe certain devices, such as reusable surgical instruments, many software devices, some substance-based devices, and most IVD devices have been up-classed under the MDR and IVDR. I.e., they are no longer self-certified and now require a Notified Body issued CE Certificate.
However, that same device may still be self-certified in the UK.
This may allow companies to market faster in Great Britain under UKCA marking, while they work on their EU CE Marking certification.
Devices that have been UKCA marked under the current legislation will be granted a transition period before they must comply with the upcoming, more stringent, UKCA regulation.
This allows you to market the device in Great Britain, generating sales revenue, while the device undergoes the sometimes 1-2 years CE Marking process.
Currently, the expected transition period is:
- UKCA Marked medical devices: three (3) year transition period after the new regulation takes effect
- UKCA Marked IVDs: five (5) year transition period after the new regulation takes effect
The caveats are:
- “devices that are subject to significant changes in design or intended purpose will be excluded from these provisions”
- “all post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements”
The new UK regulations will also up-class devices, similarly to the EU MDR/IVDR.
Therefore, if a manufacturer wishes to take advantage of the current MDD/IVDD classification system, they should UKCA mark and register their device(s) with the MHRA prior to the new regulation.
The new regulation is currently expected to be implemented late 2026/early 2027.
In Summary
Because UK regulation is still based on the old EU Directives, some devices that require a Notified Body certificate in the EU can still be self-certified under UKCA marking. This lets you get to market faster and generate sales in Great Britain while your EU CE certification is in progress.
- Devices up-classed under MDR/IVDR (reusable surgical instruments, many software devices, most IVDs, etc.) may still be self-certifiable in the UK
- UKCA Marked devices will likely have a transition period before the new stricter UK regulation becomes mandatory for them; expected to be 3 years for medical devices, 5 years for IVDs
- As the new UK regulation is expected late 2026/early 2027, the window to take advantage of current classification rules is narrowing
- Devices must be UKCA Marked and registered with the MHRA before the new regulation is implemented, in order to qualify.
