The medicines regulator of the UK has announced plans to deepen the partnership with the US FDA so as to accelerate innovation, strengthen patient safety and also decrease barriers to market access.
Speaking at the Advanced Medical Technology Association – AdvaMed conference that was held in San Diego, the chief executive, Lawrence Tallon, of the Medicines and Healthcare Products Regulatory Agency – MHRA outlined plans to go ahead and align medical technology regulation between the two countries.
The initiative happens to include the launch of a joint AI commission with the US experts and introducing faster approval routes pertaining to the devices that are already cleared by the Food and Drug Administration (FDA).
The new National Commission on the Regulation of AI in Healthcare by MHRA happens to bring together the UK and, along with it, international figures, which includes the likes of Brian Anderson from the Coalition for Health AI as well as the founder of the Center for AI Innovation in Healthcare, Barry Stein. It is well to be noted that representatives from Google as well as Microsoft are also involved.
Tallon remarked that they continue to work in close collaboration and are also taking quite serious steps forward in the relationship between the FDA and the MHRA in order to strengthen regulatory alignment as well as reciprocity. This opinion came during a fireside chat with the director at the FDA’s Center for Devices and Radiological Health, Dr. Michelle Tarver.
He added that they share an ambition to speed up joint initiatives, elevate the policy development, and also identify as well as work together on strategic opportunities in a more effective way.
The commission is going to develop recommendations pertaining to regulating AI-driven medical technologies, which would help to align with the international approaches.
It also looks forward to accelerating the safe access to AI throughout the NHS, which, by the way, serves over 65 million people.
Under the new international reliance routes, medical devices that are approved by the trusted regulators, including the FDA, are bound to gain faster access across the UK market.
What this will do is it will cover products cleared by way of the 510(k), De Novo,Premarket Approval (PMA) pathways, which happen to be the main US routes when it comes to evaluating medical devices as per the level of risk.
The MHRA said the medtech regulatory reforms of Great Britain will support earlier as well as safer patient access to innovative technologies, thereby drawing parallels with the Total Product Life Cycle Advisory Program from the FDA, which goes on to offer early engagement opportunities as far as the device developers are concerned.
According to Tallon, both the US and the UK happen to share a common goal, thereby making sure that the patients benefit quickly and, of course, safely from the latest innovations within the medical spectrum.
With US-based thought leadership going ahead and contributing to the new National AI Commission and, along with it, the new reliance frameworks for FDA approvals, they are indeed laying the foundations for a truly global and innovation-ready regulatory scenario.
It is well to be noted that the medtech regulatory reforms are most likely to get implemented in 2026, with the international reliance routes opening in 2027.
Apparently, the National Commission on the Regulation of AI in Healthcare went on to be officially launched in September 2025 so as to accelerate safe access to AI technologies throughout the NHS.
It was in July 2025 that the MHRA announced proposals so as to enhance the access to world-leading medical devices and also strengthen the medtech sector of Britain, which included the new reliance routes for approvals from regulators across Australia, Canada, and the US.
Notably, the first major overhaul of medical device regulation went on to take effect across Great Britain on 16 June 2025, thereby introducing new post-market surveillance requirements in order to elevate patient safety and also device tracking.