{"id":430098,"date":"2026-02-17T08:24:08","date_gmt":"2026-02-17T08:24:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/uk\/430098\/"},"modified":"2026-02-17T08:24:08","modified_gmt":"2026-02-17T08:24:08","slug":"mhra-launches-a-consultation-on-indefinite-recognition-of-ce-marked-medical-devices","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/uk\/430098\/","title":{"rendered":"MHRA launches\u00a0a\u00a0consultation on indefinite recognition of CE-marked medical devices\u00a0\u00a0"},"content":{"rendered":"

The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a\u00a0consultation on proposals\u00a0for\u00a0indefinite recognition of CE-marked medical devices in Great Britain (GB)<\/a>,\u00a0aimed at protecting patient access and ensuring the continued supply of safe and effective medical technologies.\u00a0<\/p>\n

Around 90% of medical devices currently used in Great Britain are CE marked, and the proposals for indefinite recognition would ensure consistent long-term\u00a0supply\u00a0to support the health system.\u00a0The\u00a0consultation seeks feedback on the proposals to\u00a0extend\u00a0arrangements\u00a0put in\u00a0place in\u00a02023 to recognise CE marked devices, and forms part of the MHRA\u2019s wider programme of regulatory reform\u00a0of medical devices, designed to be risk-proportionate, pro-innovation and patient-focused.\u00a0<\/p>\n

The consultation seeks views on three key proposals:\u00a0<\/p>\n

Extending current transitional arrangements for devices certified under the\u00a0EU\u00a0Medical Device Directive (MDD), aligning GB timelines with the EU\u2019s transition to the EU Medical Device Regulation (EU MDR), to minimise\u00a0the\u00a0risk of supply disruption.\u00a0<\/p>\n

Indefinite\u00a0recognition of EU MDR and EU IVDR-compliant devices,\u00a0to\u00a0reduce\u00a0the risk of interruption to the supply of medical devices for patients in\u00a0GB.\u00a0<\/p>\n

Introducing an international reliance route for a small\u00a0proportion\u00a0of\u00a0CE-marked devices that would fall into a higher risk class under GB rules,\u00a0to\u00a0ensure\u00a0appropriate oversight\u00a0while\u00a0maintaining\u00a0access.\u00a0<\/p>\n

These proposals\u00a0for indefinite\u00a0recognition of CE marked devices would ensure continued patient access to\u00a0essential medical devices and would be delivered alongside a domestic route to\u00a0market\u00a0focused on support for innovation, helping the UK achieve its goal of becoming a leading country for MedTech access by 2030,\u00a0and\u00a0aligned\u00a0with the Life Sciences Sector Plan.\u00a0<\/p>\n

Lawrence\u00a0Tallon,\u00a0Chief\u00a0Executive at the\u00a0MHRA\u00a0said:\u00a0<\/p>\n

\u201cThe 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.\u00a0\u00a0<\/p>\n

\u201cIn 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.\u201d\u00a0\u00a0<\/p>\n

The proposals\u00a0align\u00a0with\u00a0wider\u00a0government policy for other manufactured goods sectors where\u00a0continued\u00a0recognition of\u00a0CE marked goods\u00a0has been agreed.\u00a0Alongside these measures, the MHRA will continue to strengthen post-market surveillance and work to improve information sharing with EU partners, ensuring patient safety\u00a0remains\u00a0paramount.\u00a0<\/p>\n

The MHRA is encouraging feedback from a wide range of stakeholders, including medical device manufacturers, Approved Bodies, UK Responsible Persons, healthcare\u00a0professionals, patient\u00a0groups\u00a0and the public, to ensure the proposals deliver the best outcomes for patients and the health system.\u00a0<\/p>\n

These proposals align with the government\u2019s ambitions set out in the Life Sciences Sector\u00a0Plan\u00a0and\u00a0the 10-Year Health Plan, supporting innovation, growth\u00a0and patient access across the UK\u2019s health tech sector.\u00a0<\/p>\n

The consultation opens on 16 February\u00a02026\u00a0and will\u00a0run\u00a0until\u00a010\u00a0April\u00a02026.\u00a0<\/p>\n

Notes to editors\u00a0\u00a0<\/p>\n

This\u00a0consultation responds to feedback from stakeholders in our consultation on future routes to market for medical devices –\u00a0MHRA announces proposals to improve access to world\u2019s best medical devices for patients and to boost economic growth in Britain\u2019s med tech sector – GOV.UK<\/a><\/p>\n

The proposals extend measures\u00a0put in place in 2023 to recognise CE marked medical devices on the GB market up to 2030 –\u00a0Timeframe for accepting CE marked medical devices in Great Britain extended – GOV.UK<\/a><\/p>\n

This consultation is one part of the\u00a0MHRA\u2019s overall work to implement reform across medical device regulations<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a\u00a0consultation on proposals\u00a0for\u00a0indefinite recognition of CE-marked medical…\n","protected":false},"author":2,"featured_media":294292,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[43],"tags":[102,2960,56,54,55],"class_list":["post-430098","post","type-post","status-publish","format-standard","has-post-thumbnail","category-healthcare","tag-health","tag-healthcare","tag-uk","tag-united-kingdom","tag-unitedkingdom"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/430098","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=430098"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/430098\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/294292"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=430098"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=430098"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=430098"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}