UK and US strengthen partnership on MedTech regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) is strengthening its collaboration with the US to support faster access to safe and innovative MedTech in the future for patients in both countries.

It will work with the Food and Drug Administration (FDA) 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.

Lawrence Tallon, chief executive of the MHRA, 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.”

The US-UK pharmaceutical partnership, announced last week, further strengthens this collaboration while also removing tariffs on UK medicines exports and encourages companies to bring treatments to the UK earlier.

Dr Zubir Ahmed, health innovation and safety minister, 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.”

Both regulators’ work will remain independent and ensure strict safety standards are maintained.

Technical work between the MHRA and FDA will take place to assess opportunities for closer alignment and explore where future mutual recognition mechanisms may be appropriate.

Commenting on the partnership, Peter Ellingworth, chief executive at the Association of British HealthTech Industries, 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.”

Working with 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 products.

In December 2025, the UK and Singapore announced the launch of a regulatory ‘innovation corridor’ to fast-track major medical advances and promising health technologies, allowing companies to have a coordinated pathway enabling them to engage with both countries’ regulators at the same time.