MHRA–FDA collaboration to streamline UK market access for medical device manufacturers

Last Updated on 16/10/2025 by Sarah Sarsby

The UK Government has announced enhanced collaboration between the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).

The collaboration is intended to accelerate innovation, strengthen patient safety, and reduce barriers to transatlantic market access for medical technologies and AI.

Key developments

The MHRA will deepen its regulatory collaboration with the FDA, with a shared ambition to advance alignment and reciprocity.

During the Advanced Medical Technology Association conference in San Diego, MHRA Chief Executive Lawrence Tallon highlighted the agencies’ commitment to accelerating joint initiatives and policy development, supported by strategic opportunities for cooperation.

The MHRA has launched the National Commission on the Regulation of AI in Healthcare, bringing together UK and international experts, including contributors from the United States. The commission will develop recommendations to support the safe and transparent use of AI-driven medical technologies and to contribute to international alignment.

The agency has also confirmed plans for new international reliance routes designed to improve international investment and increase UK access to medical devices that have already been approved by trusted regulators, including the FDA.

According to the announcement, the reliance framework is intended to include products cleared through the FDA’s 510(k), De Novo, and Premarket Approval (PMA) pathways.

What this means for BHTA members

For BHTA members operating in the UK and internationally, the planned international reliance routes are expected to facilitate faster UK market access for devices already approved by trusted regulators.

The strengthened collaboration between the MHRA and FDA, together with the establishment of the National Commission on the Regulation of AI in Healthcare, signals ongoing work to align approaches to regulating medical technologies and AI.

The medtech regulatory reforms in Great Britain are intended to enter legislation in 2026  and open new reliance routes from 2027.