LONDON, Feb. 16 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched aconsultation on proposalsforindefinite 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-termsupplyto support the health system.Theconsultation seeks feedback on the proposals toextendarrangementsput inplace in2023 to recognise CE marked devices, and forms part of the MHRA's wider programme of regulatory reformof medical devices, designed to be risk-proportionate, pro-innovation and patient-focused.
The consultation seeks views on three key proposals:
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Extending current transitional arrangements for devices certified under theEUMedical Device Directive (MDD), aligning GB timelines with the EU's transition to the EU Medical Device Regulation (EU MDR), to minimisetherisk of supply disruption.
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Indefiniterecognition of EU MDR and EU IVDR-compliant devices,toreducethe risk of interruption to the supply of medical devices for patients inGB.
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Introducing an international reliance route for a smallproportionofCE-marked devices that would fall into a higher risk class under GB rules,toensureappropriate oversightwhilemaintainingaccess.
These proposalsfor indefiniterecognition of CE marked devices would ensure continued patient access toessential medical devices and would be delivered alongside a domestic route tomarketfocused on support for innovation, helping the UK achieve its goal of becoming a leading country for MedTech access by 2030,andalignedwith the Life Sciences Sector Plan.
LawrenceTallon,ChiefExecutive at theMHRAsaid:
"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 proposalsalignwithwidergovernment policy for other manufactured goods sectors wherecontinuedrecognition ofCE marked goodshas 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 safetyremainsparamount.
The MHRA is encouraging feedback from a wide range of stakeholders, including medical device manufacturers, Approved Bodies, UK Responsible Persons, healthcareprofessionals, patientgroupsand 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 SectorPlanandthe 10-Year Health Plan, supporting innovation, growthand patient access across the UK's health tech sector.
The consultation opens on 16 February2026and willrununtil10April2026.
Notes to editors
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Thisconsultation 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
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The proposals extend measuresput 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
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This consultation is one part of theMHRA's overall work to implement reform across medical device regulations
Disclaimer: Curated by HT Syndication.
