The MHRA is currently consulting on access for CE marked medical devices to the market in Great Britain (England, Scotland, and Wales) over the longer term.
At present, CE-marked devices are accepted in GB only on a temporary, transitional basis, with final cut off dates in 2028 or 2030 depending on the regulatory route. Industry feedback to previous consultations favoured indefinite recognition of CE-marked devices, prompting this targeted consultation.
The consultation applies to general medical devices, active implantable medical devices (AIMDs) and in vitro diagnostic (IVD) devices. (Northern Ireland is excluded, as it continues to apply EU MDR/IVDR under the Windsor Framework.)
The most significant proposal would permanently recognise CE marked devices that comply with current EU regulations, allowing them to access the GB market without UKCA re certification. The MHRA is also seeking views on whether this should apply to all devices, or only where EU and UK risk classifications align.
In summary, the proposals are as follows.
Alignment of GB timelines for MDD-certified devices with the current EU arrangements
This would extend GB transitional arrangements for devices certified under the EU Medical Device Directive (MDD) until 31 December 2028, instead of 30 June 202, closing a potential six month gap where devices could remain on the market in the EU but not in GB.
Indefinite recognition of CE marked devices under the MDR/IVDR
A more significant proposal would enable acceptance of CE marked devices compliant with EU MDR or EU IVDR indefinitely. Two policy options are presented:
- Indefinite recognition for all CE marked devices, or
- Indefinite recognition only where the EU risk classification is the same or lower than in GB, noting that for a small number of devices, the GB risk classification is higher than for the EU.
Devices recognised under this route would:
- Not require UKCA conformity assessment
- Still need MHRA registration
- Remain subject to the UK post market surveillance (PMS) obligations introduced in 2025
The proposal offers a trade off between faster access and reduced duplication, as against reduced direct MHRA oversight of conformity assessments conducted by EU notified bodies which could result in delays to processes such as recalls or corrections.
If this proposal does not gain support, an international reliance model for CE marked devices would be introduced instead.
International reliance route for higher risk devices
For the small number of devices where UK risk classification is higher than the EU, a tailored international reliance route is proposed. This would include a streamlined approved body review, rather than full UKCA assessment.
The consultation closes on 10 April 2026.
Our content explained
Every piece of content we create is correct on the date it’s published but please don’t rely on it as legal advice. If you’d like to speak to us about your own legal requirements, please contact one of our expert lawyers.