UK and US regulators forge new collaboration on medtech and AI
The UK’s medicines regulator has announced plans to deepen collaboration with the US FDA to accelerate innovation, strengthen patient safety and reduce barriers to market access.
Speaking at the Advanced Medical Technology Association (AdvaMed) conference in San Diego, Medicines and Healthcare products Regulatory Agency (MHRA) chief executive Lawrence Tallon outlined plans to align medical technology regulation between the two countries.
The initiatives include launching a joint AI commission with US experts and introducing faster approval routes for devices already cleared by the Food and Drug Administration (FDA).
The MHRA’s new National Commission on the Regulation of AI in Healthcare brings together UK and international figures, including Brian Anderson from the Coalition for Health AI and Barry Stein, founder of the Center for AI Innovation in Healthcare. Representatives from Google and Microsoft are also involved.
“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,” Tallon said during a fireside chat with Dr Michelle Tarver, director at the FDA’s Center for Devices and Radiological Health.
“We share an ambition to accelerate joint initiatives, enhance policy development, and identify and work together on strategic opportunities more effectively.”
The commission will develop recommendations for regulating AI-driven medical technologies, helping to align international approaches.
It will also aim to accelerate safe access to AI across the NHS, which serves more than 65 million people.
Under new international reliance routes, medical devices approved by trusted regulators including the FDA will gain faster access to the UK market.
This will cover products cleared through the 510(k), De Novo and Premarket Approval (PMA) pathways – the main US routes for assessing medical devices according to risk level.
The MHRA said Great Britain’s medtech reforms will support earlier and safer patient access to innovative technologies, drawing parallels with the FDA’s Total Product Life Cycle Advisory Program, which provides early engagement opportunities for device developers.
“The US and UK share a common goal – ensuring patients benefit quickly and safely from the latest medical innovations,” Tallon added.
“With US-based thought leadership contributing 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.”
The medtech regulatory reforms are expected to be implemented in 2026, with international reliance routes opening in 2027.
The National Commission on the Regulation of AI in Healthcare was officially launched in September 2025 to accelerate safe access to AI technologies across the NHS.
In July 2025, the MHRA announced proposals to improve access to world-leading medical devices and strengthen Britain’s medtech sector, including new reliance routes for approvals from regulators in Australia, Canada and the US.
The first major overhaul of medical device regulation took effect across Great Britain on 16 June 2025, introducing new post-market surveillance requirements to enhance patient safety and device monitoring.
