Patients to benefit as UK and US regulators forge new collaboration on medical technologies and AI
Source: gov.uk (2025-10-07)

Enhanced collaboration with the US on med tech regulation, with accelerated innovation, strengthened patient safety, and reduced transatlantic barriers to market access.

Strengthened collaboration between the UK’s MHRA and US FDA to drive innovation and accelerate patient access to latest technologies

MHRA National AI Commission launched with UK and US experts to shape safe, transparent use of AI in healthcare

New international reliance routes to improve international investment and UK access to medical devices already approved by trusted regulators, including the US FDA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will today outline moves to deepen collaboration with the US on medical technology regulation, with initiatives to accelerate innovation, strengthen patient safety, and reduce transatlantic barriers to market access.

Speaking at the Advanced Medical Technology Association (AdvaMed) conference in San Diego, MHRA Chief Executive Lawrence Tallon will highlight the agency’s commitment to advancing global regulatory harmonization and its strong partnership with the US Food and Drug Administration (FDA) during his fireside chat with Dr Michelle Tarver (Director, FDA CDRH).

Tallon says, “We continue to work in close collaboration, and are taking steps forward in the relationship between FDA and MHRA to strengthen regulatory alignment and reciprocity. We share an ambition to accelerate joint initiatives, enhance policy development, and identify and work together on strategic opportunities more effectively.”

Tallon also emphasizes that Great Britain’s medtech regulatory reforms (https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain) will support earlier and safer patient access to innovative technologies, drawing parallels with the FDA’s Total Product Life Cycle Advisory Program (TAP) (https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap) with opportunities for deeper transatlantic collaboration.

“The US and UK share a common goal – 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,” adds Tallon.

New MHRA AI Commission with US expert input

The MHRA’s new National Commission on the Regulation of AI in Healthcare (https://www.gov.uk/government/news/new-commission-to-help-accelerate-nhs-use-of-ai) brings together leading voices from across the UK and internationally,* including US experts Brian Anderson (Coalition for Health AI/CHAI) and Barry Stein (Founder of the Center for AI Innovation in Healthcare), alongside representation from global tech organizations, including Google and Microsoft.

The Commission will shape recommendations on regulating AI-driven medical technologies, contributing to international alignment and accelerating safe access to AI in healthcare and across the UK’s NHS. The 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 medtech adoption.

Faster access through international reliance

The MHRA confirms that planned international reliance routes 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 510(k) (https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k), De Novo (https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request), and Premarket Approval (PMA) (https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma) pathways, with a proportionate approach balancing rapid access with robust patient safeguards.

The medtech regulatory reforms in Great Britain are intended to enter legislation in 2026 and open new reliance routes from 2027, further strengthening the global medtech ecosystem.

Notes to Editors:

The National Commission on the Regulation of AI in Healthcare was officially launched in September 2025 (https://www.gov.uk/government/news/new-commission-to-help-accelerate-nhs-use-of-ai) to accelerate safe access to AI technologies across the NHS.

In July 2025, the MHRA announced proposals to improve access to world’s best medical devices (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) for patients and to boost economic growth in Britain’s med tech sector, including international reliance routes for devices approved by trusted regulators in Australia, Canada, and the United States.

The first major overhaul of medical device regulation came into force across Great Britain (https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain) on 16 June 2025, introducing new Post-Market Surveillance requirements to strengthen patient safety and device monitoring.

The MHRA is an executive agency of the Department of Health and Social Care.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks.

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* Membership of the new MHRA National AI Commission includes:

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’s Centre of Excellence for Regulatory Science in AI & Digital HealthTech (CERSI-AI)

Professor Henrietta Hughes, Patient Safety Commissioner

Dame Jennifer Dixon, Chief Executive of the Health Foundation

Dr Ricardo Baptista Leite, CEO, HealthAI - The Global Agency for Responsible AI in Health

Dr Brian Anderson, CEO of Coalition for Health AI (CHAI)

Richard Stubbs, Chief Executive of Health Innovation Yorkshire & Humber

Professor Neil Lawrence, DeepMind Professor of Machine Learning at the University of Cambridge and Chief Scientist at Trent AI

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

Dr Vish Ratnasuriya MBE, practising GP, Chair of Our Health Partnership, co-founder of Primary Care Accelerator and Hon Assoc Professor University of Birmingham

Dr Gabriella Spinelli, Director of RADIANT-CERSI Centre for Regulatory Science & Innovation in Digital Health & Healthcare AI, Brunel University of London

Richard Susskind CBE KC, President of the Society for Computers and Law

Dr Barry Stein, Chief Clinical Innovation Officer, Chief Medical Informatics Officer, Founder of the Center for AI Innovation in Healthcare, Attending Vascular and Interventional Radiologist, Hartford HealthCare