UK and US Deepen Regulatory Cooperation on Medical Devices
Summary
The MHRA and US FDA announced they are strengthening cooperation on medical device regulation, building on a wider US-UK pharmaceutical partnership that removes tariffs on UK medicines exports. The two regulators will explore mutual recognition mechanisms and options to reduce duplication in approval processes, while maintaining independent decision-making and stringent safety standards. Technical discussions will continue over the coming months to identify opportunities for closer regulatory alignment.
UK and US medical device manufacturers should monitor MHRA-FDA technical discussions as future mutual recognition could streamline dual-market approvals, reducing separate submission burdens while both agencies maintain independent safety standards.
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
The MHRA and FDA announced a deepened regulatory cooperation partnership focused on medical devices, building on a wider US-UK pharmaceutical agreement. The two agencies committed to exploring mutual recognition mechanisms, reducing duplicative approval processes, and improving alignment of device regulations while maintaining independent regulatory authority and strict safety standards.\n\nMedical device manufacturers seeking market access in both the UK and US should monitor this developing partnership, as future mutual recognition arrangements could reduce the burden of separate submissions. The cooperation does not create any immediate compliance obligations, but signals the direction of travel for bilateral regulatory alignment in the medtech sector.
Archived snapshot
Apr 3, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Press release
UK and US deepen regulatory cooperation on medical devices, building on wider pharmaceutical partnership
The Medicines and Healthcare products Regulatory Agency and the US Food and Drug Administration are strengthening cooperation on medical device regulation, to support faster access to safe, innovative technologies for patients in both countries.
From: Medicines and Healthcare products Regulatory Agency Published 2 April 2026 Last updated 2 April 2026
— See all updates
- The UK MHRA and the US FDA are strengthening cooperation on medical device regulation, to support faster access to safe, innovative technologies for patients in both countries.
- The announcement builds on today’s wider US-UK pharmaceutical partnership, which removes tariffs on UK medicines exports and encourages companies to launch new treatments in the UK.
- Closer US-UK regulatory collaboration supports the UK’s global life sciences leadership, reducing duplication for innovators while maintaining world-class safety standards. The Medicines and Healthcare products Regulatory Agency (MHRA) is stepping up its collaboration with the US Food and Drug Administration (FDA) to support faster access to safe and innovative medical technologies in the future for patients in both countries.
Today’s US-UK pharmaceutical partnership further strengthens this collaboration while also removing tariffs on UK medicines exports and encourages companies to bring cutting edge treatments to the UK earlier.
The MHRA and FDA will work closely on options to improve and align regulations for medical devices. This includes exploring future mutual recognition mechanisms (ways to recognise parts of the individual approval processes), 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.
Health Innovation and Safety Minister, Dr Zubir Ahmed, said:
“Closer working between the UK and the US means that future innovative medical technologies – better diagnostics, smarter devices, life-changing treatments – can reach NHS patients sooner, without compromising on the safety standards we rightly expect.
“This is the correct next step. We’ve already acted to secure improved access to life-changing medicines for NHS patients. Now we’re working to make sure the devices and technologies that go alongside them follow the same path.
“The UK is serious about being one of the best places in the world to develop and launch health innovations – and this partnership shows exactly what that commitment looks like in practice.”
UK 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.”
Lawrence Tallon, MHRA Chief Executive, said:
“This marks an exciting moment for UK innovation. By strengthening our working relationship with the FDA, we are allowing cutting edge medical technologies to reach patients faster and more efficiently than ever before.
“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.”
Working closely with trusted global regulators is a key part of MHRA’s ambition to ensure the UK remains world leading in life sciences research, development, and launching innovative new products. This will give companies clearer, more predictable processes and help patients access safe, new technologies sooner, complementing the economic and health benefits delivered through the wider US-UK partnership.
Technical work between the MHRA and FDA will continue over the coming months to assess opportunities for closer alignment and explore where future mutual recognition mechanisms may be appropriate.
Any future arrangements will continue to meet the UK’s stringent statutory requirements for safety, quality, and effectiveness.
Peter Ellingworth, ABHI Chief Executive, said:
“Closer cooperation between the MHRA and FDA is a positive step towards reducing regulatory duplication and accelerating patient access to HealthTech that saves and enhances lives. 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:
“This commitment by the MHRA and FDA to deepen regulatory cooperation 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.
“techUK has long called for smarter, internationally connected regulation, and this announcement shows real momentum toward reducing duplication while maintaining the highest standards of safety and effectiveness. Closer cooperation will be especially valuable for UK innovators and SMEs, helping them navigate regulatory requirements more effectively and bring breakthrough products to market faster.
“We look forward to working with both regulators, industry, and the wider health system to help realise the benefits of this approach and strengthen the UK’s position as a global leader in medical technology.”
Notes to editors:
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- The US Food and Drug Administration (FDA) is responsible for protecting public health in the United States by ensuring the safety, efficacy and security of human and veterinary medicines, biological products, and medical devices.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
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Published 2 April 2026 Last updated 2 April 2026 show all updates
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2 April 2026
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2 April 2026
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