Emerging healthcare technologies will be tested in real NHS settings under a new regulatory sandbox launched by the MHRA in partnership with Manchester University NHS Foundation Trust (MFT).
The Manchester Sandbox will bring together developers, clinicians and regulators to generate evidence on how new technologies perform in day-to-day clinical practice, with the aim of accelerating the safe adoption of innovations that demonstrate value.
The first technologies are expected to include AI-enabled medical devices, including tools designed to identify patients at increased risk of complications from long-term conditions and support earlier intervention.
“Manchester is leading the way in getting the best new technologies into the hands of local patients faster,” said, James Frith, Health Innovation Minister, in a press release announcing the scheme.
Aims, deployment and safety
The initiative aims to address a key challenge facing healthcare innovators: demonstrating that a technology works not only in development or controlled studies, but also in real-world clinical settings.
Technologies will be deployed and assessed with regulatory oversight, allowing the MHRA and NHS partners to examine safety, effectiveness and their impact on clinical workflows.
For developers, the programme could provide earlier clarity on the evidence required for wider NHS adoption and identify regulatory or implementation challenges before technologies are scaled.
“But innovation must never come at the expense of safety,” Frith added. “That is why this partnership will test out new technologies in real NHS settings, but with strict oversight and guardrails.”
Building on previous initiatives
The Manchester Sandbox builds on the MHRA’s existing AI Airlock programme, launched in 2024 to explore regulatory challenges surrounding AI as a medical device.
The agency secured £3.6m in funding earlier this year to expand the programme through 2029. The Manchester initiative represents a further move towards testing technologies alongside NHS organisations and developers before wider deployment.
Why Manchester?
MFT is one of the UK’s largest NHS trusts and sits within a wider health innovation ecosystem spanning NHS organisations, universities, research institutions and technology companies.
The programme will give developers access to large and diverse patient populations, allowing technologies to be thoroughly evaluated in real-world settings and produce reliable evidence. However, participation in the sandbox will not itself guarantee regulatory approval or NHS adoption.
What happens next?
Following today’s launch, the MHRA plans to invite medical device developers to express interest in participating in the programme. So far, no participating companies or technologies have been announced.
Later this year, MFT and the MHRA will hold a roundtable involving healthcare providers, innovators, researchers and patient representatives to explore future opportunities and help shape the next wave of the project.
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