Key Summary
- MHRA and FDA are strengthening ties to streamline the regulation of medical devices and innovative health technologies.
- By exploring mutual recognition mechanisms, the regulators aim to provide patients speedier access to cutting-edge medical tools.
- MHRA chief executive Lawrence Tallon said the partnership will enable the UK to stay at the forefront of global life sciences.
The Medicines and Healthcare products Regulatory Agency will collaborate with US Food and Drug Administration (FDA) for a medical device regulation that will support faster access to safe, innovative technologies for patients in both countries.
The collaboration between the two regulators is part of UK-US pharmaceutical partnership and will help reduce duplication for innovators while maintaining world-class safety standards.
The MHRA and FDA will work closely on options to improve and align regulations for medical devices.
This includes exploring future mutual recognition mechanisms, reducing duplication for manufacturers and streamlining approval processes to help patients access new medical technologies sooner.
Both regulators’ work will remain independent and ensure strict safety standards are maintained.
MHRA chief executive Lawrence Tallon said, “This is exactly the kind of partnership that enables the UK to stay at the forefront of global life sciences.
“Importantly, this is just the beginning, and I am looking forward to building on the growing US-UK collaboration as we continue to strengthen our shared commitment to safe, high-quality innovation for patients.”
Association of British HealthTech Industries (ABHI) chief executive Peter Ellingworth said, “For UK businesses, greater alignment between two of the world’s leading regulators will provide more predictable pathways and support faster routes to market, while maintaining the highest standards of safety and performance.
“It will also strengthen the UK’s position as an attractive launch market for investment, ultimately ensuring patients in both the UK and US benefit earlier from global innovation. ABHI has long advocated for this approach and is committed to supporting its delivery.”
Julian David, techUK Chief Executive, said the MHRA-FDA collaboration is an “important step forward for patients and for the UK’s health sector. Greater alignment between trusted regulators will give innovators clearer, more predictable pathways and help ensure that safe, cutting‑edge technologies reach patients more quickly.”
Science minister Lord Vallance said, “The UK’s MedTech sector employs over 195,000 people and leads the way on innovative and important technologies that help us lead healthy, longer lives.
“The MHRA is a global leader in regulation and this partnership with the US will strengthen this further, providing faster access to safe and innovative medical devices in both our countries.”
