The MHRA has outlined 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.
At AdvaMed in San Diego, MHRA Chief Executive Lawrence Tallon highlighted the agency’s commitment to advancing global regulatory harmonisation and its strong partnership with the US Food and Drug Administration (FDA) during his fireside chat with Dr Michelle Tarver (Director, FDA CDRH).
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 organisations, 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 MHRA confirmed 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.
