Patients in both the United Kingdom and United States are set to benefit from a new partnership between the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA) aimed at accelerating innovation in medical technology and artificial intelligence (AI).
Announced at the Advanced Medical Technology Association (AdvaMed) conference in San Diego, the collaboration will expand regulatory alignment between the two agencies to improve patient access to the latest medical devices while maintaining strong safety standards. MHRA Chief Executive Lawrence Tallon emphasized that the joint effort will “strengthen regulatory alignment and reciprocity,” ensuring patients receive cutting-edge technologies faster and more safely.
As part of the initiative, the MHRA launched a new National Commission on the Regulation of AI in Healthcare. The Commission includes leading voices from the UK and the U.S., such as Brian Anderson of the Coalition for Health AI and Barry Stein of Hartford HealthCare’s Center for AI Innovation in Healthcare, alongside representatives from global technology firms like Google and Microsoft. The group will help shape international guidance on AI regulation in healthcare, promoting transparency, safety, and faster adoption of AI-driven medical tools across the NHS.
The MHRA also confirmed plans to introduce “international reliance routes,” allowing medical devices approved by trusted regulators, including the FDA, to gain faster entry into the UK market. These routes will include devices cleared through the 510(k), De Novo, and Premarket Approval pathways, with implementation expected in 2027.
According to the MHRA, these reforms—part of the UK’s first major overhaul of medical device regulation since June 2025—aim to enhance patient safety, foster innovation, and attract global investment in Britain’s rapidly growing medtech sector.
Need Help?
If you have questions or concerns about any US, UK, or global guidelines, regulations and laws, don’t hesitate to reach out to BABL AI. Their Audit Experts can offer valuable insight, and ensure you’re informed and compliant.
