{"id":483180,"date":"2025-10-08T14:40:12","date_gmt":"2025-10-08T14:40:12","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/483180\/"},"modified":"2025-10-08T14:40:12","modified_gmt":"2025-10-08T14:40:12","slug":"patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/483180\/","title":{"rendered":"Patients to benefit as UK and US regulators forge new collaboration on medical technologies and AI"},"content":{"rendered":"<ul>\n<li>\n<p>Strengthened\u202fcollaboration between the\u202fUK\u2019s\u202fMHRA and\u202fUS\u202fFDA\u202fto\u202fdrive innovation\u202fand accelerate patient access to\u202flatest\u202ftechnologies\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>MHRA National AI Commission\u202flaunched\u202fwith UK and US experts to\u202fshape safe,\u202ftransparent\u202fuse\u202fof\u202fAI in healthcare\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>New international reliance routes to\u202fimprove\u202finternational investment\u202fand\u202fUK access to medical devices already approved by trusted regulators, including the US FDA\u202f\u00a0<\/p>\n<\/li>\n<\/ul>\n<p>The\u202f UK\u2019s Medicines and Healthcare products Regulatory Agency (MHRA)\u202fwill\u202f today\u202foutline\u202fmoves\u202fto deepen collaboration with the US\u202fon medical technology regulation,\u202fwith\u202finitiatives to accelerate innovation, strengthen patient safety, and reduce\u202ftransatlantic\u202fbarriers to market access.\u202f\u00a0<\/p>\n<p>Speaking at the\u202fAdvanced Medical Technology Association (AdvaMed)\u202fconference in San Diego, MHRA Chief Executive Lawrence Tallon\u202fwill highlight the agency\u2019s commitment to advancing global regulatory harmonization and its strong\u202fpartnership\u202fwith the US Food and Drug Administration (FDA)\u202fduring\u202fhis fireside chat with Dr Michelle\u202fTarver (Director, FDA CDRH).\u202f\u00a0<\/p>\n<p>Tallon\u202fsays,\u202f\u201cWe\u202fcontinue to work in close collaboration, and are\u202ftaking steps\u202fforward in the relationship between FDA and MHRA to strengthen regulatory alignment and reciprocity.\u202f We share\u202fan\u202fambition to accelerate joint initiatives, enhance policy development, and\u202fidentify\u202fand work together on strategic opportunities more effectively.\u201d\u00a0<\/p>\n<p>Tallon also emphasizes that Great Britain\u2019s\u202f <a href=\"https:\/\/www.gov.uk\/government\/news\/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain\" target=\"_blank\" rel=\"noopener\">medtech\u202fregulatory reforms<\/a> \u202fwill support earlier and safer patient access to innovative technologies, drawing parallels with the\u202f <a rel=\"external noopener\" href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/total-product-life-cycle-advisory-program-tap\" target=\"_blank\">FDA\u2019s\u202fTotal Product Life Cycle Advisory Program (TAP)<\/a>\u202f with\u202fopportunities for deeper transatlantic collaboration.\u202f\u00a0<\/p>\n<p>\u201cThe US and UK share a common goal \u2013 ensuring patients benefit quickly and safely from the latest medical innovations. With US-based thought leadership inputting to our new National AI Commission, and new reliance frameworks for FDA approvals, we are laying the foundations for a truly global, innovation-ready regulatory environment,\u201d adds Tallon.\u202f\u202f\u00a0<\/p>\n<p>New\u202f MHRA AI Commission with US expert input\u00a0<\/p>\n<p>\u00a0The MHRA\u2019s\u202f new\u202f <a href=\"https:\/\/www.gov.uk\/government\/news\/new-commission-to-help-accelerate-nhs-use-of-ai\" target=\"_blank\" rel=\"noopener\">National Commission on the Regulation of AI in Healthcare<\/a>\u202f brings together leading\u202fvoices from across the UK and internationally,*\u202fincluding US experts Brian Anderson (Coalition for Health AI\/CHAI) and Barry Stein (Founder of the\u202fCenter\u202ffor AI Innovation in Healthcare), alongside\u202frepresentation from\u202fglobal tech organizations, including\u202fGoogle\u202fand Microsoft.\u202f\u202f\u00a0<\/p>\n<p>The Commission will shape recommendations on regulating AI-driven medical technologies,\u202fcontributing to\u202finternational\u202falignment\u202fand accelerating\u202fsafe access to AI in healthcare and across the UK\u2019s NHS.\u202f\u202fThe NHS is a single, nationwide health system covering over 65 million people, offering unparalleled scale, trusted real-world data, and integrated pathways that make the UK a uniquely competitive environment for health innovation and\u202fmedtech\u202fadoption.\u202f\u00a0<\/p>\n<p>Faster\u202f access through international reliance\u202f\u00a0<\/p>\n<p>The MHRA confirms that\u202fplanned\u202finternational\u202freliance\u202froutes will allow medical devices approved by trusted regulators, including the FDA, to gain faster access to the UK market. This includes products cleared through the \u202f<a rel=\"external noopener\" href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/premarket-notification-510k\" target=\"_blank\">510(k)<\/a>, \u202f<a rel=\"external noopener\" href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/de-novo-classification-request\" target=\"_blank\">De Novo<\/a>, and \u202f<a rel=\"external noopener\" href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/premarket-approval-pma\" target=\"_blank\">Premarket Approval (PMA)<\/a>\u202fpathways, with a proportionate approach balancing rapid access with robust patient safeguards.\u202f\u00a0<\/p>\n<p>The medtech regulatory reforms\u202fin Great\u202fBritain\u202fare\u202fintended to\u202fenter legislation in 2026\u202f and\u202fopen new reliance routes from 2027, further strengthening the global\u202fmedtech\u202fecosystem.\u202f\u00a0<\/p>\n<p>Notes to Editors:\u202f\u00a0<\/p>\n<ul>\n<li>\n<p>The National Commission on the Regulation of AI in Healthcare was \u202f<a href=\"https:\/\/www.gov.uk\/government\/news\/new-commission-to-help-accelerate-nhs-use-of-ai\" target=\"_blank\" rel=\"noopener\">officially launched in September 2025<\/a>\u202fto accelerate safe access to AI technologies across the NHS.\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>In July 2025, the MHRA\u202f <a href=\"https:\/\/www.gov.uk\/government\/news\/mhra-announces-proposals-to-improve-access-to-worlds-best-medical-devices-for-patients-and-to-boost-economic-growth-in-britains-med-tech-sector\" target=\"_blank\" rel=\"noopener\">announced proposals to improve access to world\u2019s best medical devices<\/a>\u202ffor patients and to boost economic growth in Britain\u2019s med tech sector, including international reliance routes for devices approved by trusted regulators in Australia, Canada, and the United States.\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>The \u202f<a href=\"https:\/\/www.gov.uk\/government\/news\/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain\" target=\"_blank\" rel=\"noopener\">first major overhaul of medical device regulation came into force across Great Britain<\/a>\u202fon 16 June 2025, introducing new Post-Market Surveillance requirements to strengthen patient safety and device monitoring.\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>The Medicines and Healthcare products Regulatory Agency (MHRA)\u202fis responsible for\u202fregulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.\u202f All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks.\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>For media enquiries, please contact the \u202f<a href=\"https:\/\/www.gov.uk\/government\/news\/mailto:newscentre@mhra.gov.uk\" target=\"_blank\" rel=\"noopener\">newscentre@mhra.gov.uk<\/a>, or call on 020 3080 7651.\u202f\u00a0<\/p>\n<\/li>\n<\/ul>\n<p>*\u202fMembership of the new MHRA National AI Commission includes:\u202f\u202f\u202f\u00a0<\/p>\n<ul>\n<li>\n<p>Professor Alastair Denniston, Professor of Regulatory Science and Innovation at the University of Birmingham, Honorary Consultant Ophthalmologist at University Hospitals Birmingham NHS Foundation Trust and Executive Director of the UK\u2019s Centre of Excellence for Regulatory Science in AI &amp; Digital HealthTech (CERSI-AI)\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Professor Henrietta Hughes, Patient Safety Commissioner\u202f\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Dame Jennifer Dixon, Chief Executive of the Health Foundation\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Dr Ricardo Baptista Leite, CEO,\u202fHealthAI\u202f- The Global Agency for Responsible AI in Health\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Dr Brian Anderson, CEO of Coalition for Health AI (CHAI)\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Richard Stubbs, Chief Executive of Health Innovation Yorkshire &amp; Humber\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Professor Neil Lawrence, DeepMind Professor of Machine Learning at the University of Cambridge and Chief Scientist at Trent AI\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Professor Cathie Sudlow, Head of School of Population Health Sciences, Director of Usher Institute, University of Edinburgh, Director, UKRI Adolescent Health Study, Director of Generation Scotland\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Dr Vish\u202fRatnasuriya\u202fMBE, practising GP, Chair of Our Health Partnership, co-founder of Primary Care Accelerator and Hon Assoc Professor University of Birmingham\u202f\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Dr Gabriella Spinelli, Director of RADIANT-CERSI Centre for Regulatory Science &amp; Innovation in Digital Health &amp; Healthcare AI, Brunel University of London\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Richard Susskind CBE KC, President of the Society for Computers and Law\u202f\u202f\u202f\u00a0<\/p>\n<\/li>\n<li>\n<p>Dr Barry Stein, Chief Clinical Innovation Officer, Chief Medical Informatics Officer, Founder of the\u202fCenter\u202ffor AI Innovation in Healthcare, Attending Vascular and Interventional Radiologist, Hartford HealthCare<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"Strengthened\u202fcollaboration between the\u202fUK\u2019s\u202fMHRA and\u202fUS\u202fFDA\u202fto\u202fdrive innovation\u202fand accelerate patient access to\u202flatest\u202ftechnologies\u202f\u00a0 MHRA National AI Commission\u202flaunched\u202fwith UK and US experts to\u202fshape&hellip;\n","protected":false},"author":2,"featured_media":482837,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4],"tags":[748,393,4884,1144,712,16,15,1764],"class_list":{"0":"post-483180","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-uk","8":"category-united-kingdom","9":"tag-britain","10":"tag-england","11":"tag-great-britain","12":"tag-northern-ireland","13":"tag-scotland","14":"tag-uk","15":"tag-united-kingdom","16":"tag-wales"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/115339069054647126","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/483180","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=483180"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/483180\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/482837"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=483180"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=483180"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=483180"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}