October 21, 2026
Short answer: Yes. CE marked medical devices and IVDs will continue to be accepted in Great Britain. On 21 October 2026, the UK Government confirmed that devices CE marked under EU MDR and EU IVDR will be recognised in Great Britain indefinitely. Devices under the older EU MDD will be recognised in line with EU transition timelines, currently to 31 December 2028. Manufacturers must still appoint a UK Responsible Person, register with the MHRA and meet GB post-market surveillance requirements.
This guide explains what has changed, what hasn’t, and what medical device manufacturers need to do now.
For most devices, yes. Before this decision, CE marked medical devices could be placed on the GB market only until 30 June 2028 or 30 June 2030, depending on the device type and the EU legislation it was certified under. After those dates, manufacturers expected to need UKCA marking.
The government has now confirmed it will:
The changes need parliamentary approval and will be made before 30 June 2028. Until the new legislation is in force, the current rules continue to apply.
The targeted consultation on indefinite recognition of CE marked medical devices ran from 16 February to 10 April 2026 and received 1,056 responses. Medical device and IVD manufacturers made up 63% of organisational and professional respondents.
Respondents were asked about four proposals:
The government decided not to proceed with Proposals 2b and 3. It concluded that a separate route for devices with different GB classifications would add regulatory complexity without enough benefit.
Northern Ireland is not covered by this change and follows separate MHRA guidance.
Indefinite recognition does not mean “nothing to do”. To place CE marked medical devices on the GB market, you must continue to:
The MHRA keeps full responsibility for device safety in the UK. That includes market surveillance, investigating non-compliance and adverse incidents, and running the Yellow Card scheme.
No, not if your devices are CE marked under EU MDR or EU IVDR and you meet the GB requirements above. UKCA marking remains available as an alternative route, and some manufacturers may still choose it, for example if they focus on the UK market or don’t hold EU certification.
The difference is that UKCA is now a commercial choice rather than a regulatory deadline. For manufacturers selling in both the EU and GB, keeping one CE certification avoids duplicated conformity assessment costs.
This decision gives long-term certainty, so it’s a good time to check that your GB compliance is solid:
When does indefinite CE recognition come into force?
The changes need parliamentary approval. The government has committed to making them before 30 June 2028. Until then, the current rules apply.
Does indefinite recognition apply to IVDs?
Yes. IVDs CE marked under EU IVDR are included.
What happens to devices under the old Medical Devices Directive (MDD)?
They will be recognised in GB in line with EU transition timelines, currently 31 December 2028, as long as they continue to meet the requirements of regulation 19B of the UK Medical Devices Regulations 2002.
Do I still need a UK Responsible Person?
Yes, if you are based outside the UK.
Does this apply in Northern Ireland?
No. Northern Ireland follows separate guidance.
Is UKCA marking being scrapped?
No. UKCA remains available alongside CE recognition.
Taylored Consultancy helps medical device, SaMD and IVD manufacturers get to and stay on the GB market. We support UK Responsible Person readiness, MHRA device registration, post-market surveillance and vigilance systems, and strategic advice on UKCA versus CE marking.
Speak to our medical devices team
Source: Government response to the targeted consultation on indefinite recognition of CE marked medical devices, 21 October 2026.
