Patients to benefit as UK and US regulators forge new collaboration on medical technologies and AI
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 will support earlier and safer patient access to innovative technologies, drawing parallels with the FDA’s 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 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), De Novo, and 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.
