The Medicines and Healthcare products Regulatory Agency (MHRA)
has today launched a consultation on
proposals for indefinite recognition of CE-marked
medical devices in Great Britain (GB), aimed at
protecting patient access and ensuring the continued supply of
safe and effective medical technologies.
Around 90% of medical devices currently used in Great Britain are
CE marked, and the proposals
for indefinite recognition would ensure consistent long-term supply to
support the health system. The consultation seeks
feedback on the proposals
to extend arrangements put in place
in 2023
to recognise CE marked devices, and forms part
of the MHRA's wider programme of regulatory reform of
medical devices, designed to be risk-proportionate,
pro-innovation and patient-focused.
The consultation seeks views on three key proposals:
-
Extending current transitional arrangements for devices
certified under the EU Medical Device Directive
(MDD), aligning GB timelines with the EU's transition to
the EU Medical Device Regulation (EU MDR), to
minimise the risk of supply disruption.
-
Indefinite recognition of EU MDR and EU IVDR-compliant
devices, to reduce the risk of interruption to
the supply of medical devices for patients in GB.
-
Introducing an international reliance route for a
small proportion of CE-marked devices that
would fall into a higher risk class under GB
rules, to ensure appropriate
oversight while maintaining access.
These proposals for indefinite recognition of
CE marked devices would ensure continued patient access to essential
medical devices
and would be delivered alongside
a domestic route to market focused
on support for innovation, helping the
UK achieve its goal of becoming a leading country for MedTech
access by 2030, and aligned with the Life Sciences
Sector Plan.
Lawrence Tallon, Chief Executive at
the MHRA said:
“The number one request that the med tech industry made of us was
to provide long term certainty over CE recognition. It is in the
best of interests of British patients to ensure continued access
to the latest medical devices approved in Europe. It is also in
the best interests of the med tech sector to reduce friction and
costs of doing business. We have listened carefully and acted on
this clear and consistent feedback, which is why we are now
pleased to consult on these proposals for indefinite recognition
of CE marked medical devices.
“In addition, we will re-position UKCA as a specialist route for
first-in-market innovative products, including AI as a medical
device. This will be informed by the findings of the National
Commission into the Regulation of AI in Healthcare which will
report this summer.”
The proposals align with wider government
policy for other manufactured goods sectors
where continued recognition of CE marked
goods has been agreed. Alongside these measures, the
MHRA will continue to strengthen post-market surveillance and
work to improve information sharing with EU partners, ensuring
patient safety remains paramount.
The MHRA is encouraging feedback from a wide range of
stakeholders, including medical device manufacturers, Approved
Bodies, UK Responsible Persons, healthcare professionals,
patient groups and the public, to ensure the proposals
deliver the best outcomes for patients and the health
system.
These proposals align with the government's ambitions set out in
the Life Sciences Sector Plan and the 10-Year
Health Plan, supporting innovation, growth and patient
access across the UK's health tech sector.
The consultation opens on 16 February 2026 and
will run until 10 April 2026.
Notes to editors
-
This consultation responds to feedback from stakeholders
in our consultation on future routes to market for medical
devices - MHRA announces
proposals to improve access to world's best medical devices
for patients and to boost economic growth in Britain's med
tech sector - GOV.UK
-
The proposals extend measures put in place in 2023 to
recognise CE marked medical devices on the GB market up to
2030 - Timeframe for
accepting CE marked medical devices in Great Britain extended
- GOV.UK
-
This consultation is one part of the MHRA's overall work to
implement reform across medical device regulations
