Expressions of interest are now open for London Region I, a regulatory sandbox that will support the safe, real-world deployment and evaluation of AI-enabled medical devices in NHS settings.
The programme is inviting AI device manufacturers and NHS providers across London to take part, with London being the first NHS region to adopt a regulatory sandbox approach.
Full details, eligibility criteria and the expression of interest forms are available on GOV.UK.
London Region I is led by the Medicines and Healthcare products Regulatory Agency (MHRA), working with NHS England (London) and the three London health innovation networks. Imperial College Health Partners (ICHP) has shaped the development of the sandbox approach alongside London’s health innovation networks (HINs), UCLPartners and Health Innovation Network South London. This has led to a new model for how regulators, innovators and NHS organisations can work together to accelerate safe adoption of AI technologies across the NHS.
Why this matters
One of the biggest barriers facing health technology innovators is navigating regulation and generating the evidence required for adoption. London Region I has been designed to bring innovators, regulators and providers into the same process, creating the conditions in which promising technologies can be evaluated, trusted and scaled.
Who can express interest
The MHRA is inviting expressions of interest from:
- Manufacturers and developers of AI-enabled medical devices
- NHS providers across primary, community, mental health and secondary care settings inLondon
- Joint submissions from manufacturers and providers already interested in working together
- Organisations seeking to participate as both a manufacturer and provider
Up to 10 AI medical device manufacturers will be selected for the initial phase. All providers meeting the eligibility criteria may participate.
What the programme is looking for
London Region I is seeking devices that address one or more of three challenges, aligned to the 10-Year Health Plan for England:
- Driving the shift to preventative care, with a focus on preventing heart disease and tackling inequalities in heart health care, or other technologies that enable healthier lifestyles
- Embedding the new neighbourhood health service, with increased capacity and capability to deliver high quality care in local communities
- Maximising the utility of the NHS App to increase digital access to and engagement with health services
What participants can expect
For innovators, the programme offers the opportunity to generate real-world data on safety, effectiveness and patient benefit, to work directly with regulators and NHS providers, and to explore routes towards wider adoption and market access.
For providers, it offers earlier access to promising technologies under MHRA oversight, a role in evaluating innovations against local clinical and operational priorities, and a contribution to the evidence base for technologies that could improve outcomes, capacity and access to care.
Abeer Itrakjy, Associate Director of Innovation and Implementation, who is leading ICHP’s work on the sandbox, said:
“Innovators consistently tell us that navigating regulation is one of the biggest barriers to getting their technology into the NHS. That’s why we have worked with the MHRA, NHS England and our fellow London health innovation networks (HINs) to develop London Region I. It gives AI developers and NHS providers the opportunity to evaluate technologies in real-world settings with the MHRA alongside them from the outset and generate the evidence needed for adoption. We would encourage eligible innovators and providers in North West London to express interest.”
How to express interest
To express interest, download the relevant form from the GOV.UK page: a Manufacturer Expression of Interest form or a Provider Expression of Interest form. Completed forms should be returned by email to LondonRegion-i@mhra.gov.uk. Organisations participating as both manufacturer and provider, or as a partnership, should complete a form for each role and send them together in a single email.
Enquiries about the programme should be directed to the MHRA at LondonRegion-i@mhra.gov.uk.
Read more on why ICHP has been involved in developing this approach: Creating the conditions for innovation and transformation through a regulatory sandbox.
Looking for regulatory support? ICHP offers two complementary routes, serving different needs
For innovators in North West London, London Region I is part of a wider package of regulatory support available through ICHP. While the sandbox focuses on real-world deployment and evidence generation for AI-enabled medical devices, our partnership with regulatory technology company fsub helps innovators to understand and prepare for regulatory requirements earlier in their journey. Innovators can use either or both.
| London Region I (MHRA regulatory sandbox) | Regulatory support through fsub (ICHP partnership) |
|---|---|
| A London regional programme led by the MHRA with NHS England (London) and the three London health innovation networks. | A separate ICHP offer, delivered in partnership with regulatory technology company fsub. |
| A route to authorised, real-world deployment of AI-enabled medical devices in NHS settings, with structured monitoring. | Structured regulatory guidance through fsub’s Regulatory Navigator platform, helping innovators understand which requirements apply to their product and build towards compliance. |
| A defined pilot cohort of up to ten manufacturers, with a time-limited expression of interest process via GOV.UK. | Available on an ongoing basis through ICHP’s Innovation Exchange programme, rather than through a time-limited application window. |
Specialist regulatory advice is often needed long before an early stage company has secured investment, and this is exactly when expert support is hardest to reach. Through fsub’s Regulatory Navigator platform, available via our Innovation Exchange programme, innovators can understand which requirements apply to their product, develop the key documents needed for compliance, and build quality and risk management foundations to recognised standards.
Find out more about the partnership on ICHP website.
Which route is right for you?
| If you want to… | Consider… |
|---|---|
| Deploy an AI-enabled medical device in real NHS settings, with MHRA oversight, as part of a structured pilot | London Region I: express interest via GOV.UK |
| Participate as an NHS provider evaluating and adopting AI technologies | London Region I: express interest via GOV.UK |
| Understand which regulatory requirements apply to your health tech product and build towards compliance | ICHP’s regulatory support offer through fsub, via our Innovation Exchange |
| Work out which route suits your innovation, or access wider adoption support in NW London | Contact ICHP or complete our innovator engagement form |
For wider support with bringing an innovation into the NW London system, including our innovation surgeries, see our support to innovators page.
