London Region I MHRA Regulatory Sandbox: call for expressions of interest
Published 30 July 2026
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Overview
The London Region I MHRA Regulatory Sandbox, announced in June 2026, will bring together AI-enabled medical device manufacturers, NHS organisations and regulatory experts to explore the safe and responsible deployment of innovative technologies in real-world healthcare settings in London.
The programme aims to accelerate access to promising innovations by generating robust real-world evidence of ongoing safety and effectiveness, helping to inform regulatory decision-making and support a clearer, more predictable route to wider adoption.
We are particularly interested in AI-enabled devices that support:
- preventative and proactive care, especially with a focus on heart health care
- embedding the neighbourhood health services and community-based care with increased capacity and capability
- increasing digital access to healthcare services, including through maximising the utility of the NHS App
- other innovations that could improve patient outcomes and healthcare delivery in London
Up to 10 AI medical device manufacturers will be selected to participate in the initial phase, working alongside NHS providers across London to deploy technologies in live clinical settings under MHRA oversight.
Who can provide and expression of interest
Expressions of interest are welcomed from:
- AI-enabled medical device manufacturers
- NHS provider organisations in Greater London
- organisations seeking to participate as both a manufacturer and provider
- provider-manufacturer partnerships wishing to participate together
Full eligibility criteria can be found in the Expression of Interest forms.
Fees and costs
There is no fee to apply to or participate in the programme.
Applicants should be prepared to meet their own costs associated with participation, including staff time, evidence generation, governance and information governance activities, deployment planning, implementation, evaluation, data access and any other activities required to support participation in the Regulatory Sandbox.
How to provide an expression of interest
Complete the relevant expression of interest form:
Completed forms should be provided via email to LondonRegion-i@mhra.gov.uk. For organisations seeking to participate as both a manufacturer and provider, or provider-manufacturer partnerships, please complete the appropriate expression of interest form for each role and/or participating organisation and supply these together in a single email to LondonRegion-i@mhra.gov.uk.
The call for expressions of interest will remain open until 10 devices have been successfully selected, assessed, and deployed. This page will be updated when expressions of interest have closed.
Further information
If you would like to ask any questions, please email LondonRegion-i@mhra.gov.uk.