MHRA launches Manchester sandbox for AI medical devices in NHS 2026

Key Points

• The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced its first regional technology sandbox in collaboration with Manchester University NHS Foundation Trust (MFT).
• The Manchester Sandbox will be a place for testing innovative technologies including AI-powered medical devices in NHS clinical environments under stringent regulatory control.
• The programme hopes to gather real-world evidence about the effectiveness and safety of such innovations as well as expedite the access of patients across Greater Manchester to innovations.
• According to MHRA, this programme is intended to help find any possible roadblocks during regulatory requirements, NHS adoption, data and clinical evaluation pathways.
• In addition, MHRA is trying to see how to introduce similar regional innovation hubs across other regions of the United Kingdom.
• Speaking on the event, Health Innovation Minister James Frith noted that innovations should not be at the cost of safety and called for safe testing under guardrails.
• MHRA is looking for medical device developers to participate in the second phase and plans to organize a joint roundtable with MFT during 2026.

Manchester (Manchester Mirror) September 02, 2026 – The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has officially launched its first regional technology “sandbox” in Manchester, marking a significant expansion of its innovation programme beyond London-based initiatives. The sandbox, established through a partnership with MFT, is designed to create a regulator-monitored environment where developers, researchers and health systems can test new technologies, including artificial intelligence (AI) and advanced predictive modelling, within live NHS clinical settings.

What is the MHRA Manchester sandbox and how does it work?

The MHRA Manchester sandbox is a regional innovation hub that allows new health technologies to be deployed and tested in real-world NHS environments under active regulatory oversight. Unlike traditional pre-market assessments conducted in controlled laboratories or simulated settings, the Manchester Sandbox enables technologies to be evaluated with actual patients and clinicians during day-to-day practice, generating robust evidence on performance, safety and effectiveness.

As reported by Mylo Kaye of PharmaPhorum, the sandboxes are designed to create a safe, regulator-monitored environment where developers, researchers, and health systems can test new technologies, including artificial intelligence and advanced predictive modelling. The Manchester initiative joins MHRA’s existing centralised programmes, which focus on software or AI used as a medical device (SaMD/AIaMD) and the use of AI for modernising medicines development and safety, overseen from MHRA’s London headquarters in Canary Wharf.

Which technologies will be tested first in the Manchester sandbox?

The first technologies expected to enter the Manchester Sandbox include AI-enabled medical devices capable of identifying patients at higher risk of complications from long-term conditions, enabling earlier support and treatment. These tools are intended to support earlier diagnosis, more personalised care and faster access to proven innovations for patients in the city, while helping NHS trusts improve patient safety and reduce pressure on overstretched services.

According to PharmaPhorum’s report by Mylo Kaye, the first technologies to be put through their paces in Manchester are expected to include AI-enabled medical devices, such as tools that can identify patients at higher risk of complications from long-term conditions, enabling earlier support and treatment. The emphasis on risk stratification tools reflects broader MHRA priorities around using AI to enhance medicines safety and clinical decision-making without compromising regulatory standards.

How will the Manchester sandbox accelerate safe access to innovation?

One of the key goals of expanding into regional hubs like Manchester is to build a unified, UK-wide regulatory support network for new technologies, ensuring equitable and rapid access across the entire country. MHRA has stated that the innovation hub model is designed to “identify and remove barriers earlier, providing faster clarity on regulatory requirements, NHS adoption and spread, data needs, and clinical evaluation pathways”.

By embedding regulatory oversight within live clinical environments, the sandbox aims to shorten the time between technological development and routine NHS use, while maintaining strict safety guardrails. This approach allows regulators, clinicians and developers to collaboratively address practical challenges around data integration, workflow compatibility and clinical validation before wider deployment.

What have government and MHRA officials said about the initiative?

Health Innovation Minister James Frith commented on the launch, stating:

“Manchester is leading the way in getting the best new technologies into the hands of local patients faster – from AI models that can identify people at risk sooner to innovative treatments that could transform NHS care.”

He added:

“But innovation must never come at the expense of safety. That is why this partnership will test out new technologies in real NHS settings but with strict oversight and guardrails, helping us to identify what works, in a carefully controlled way, and making a real difference to patients across Greater Manchester.”

MHRA has indicated that the Manchester Sandbox represents a strategic step towards decentralising innovation support, complementing its centralised AI and SaMD programmes with regionally grounded testing capacity. The agency emphasised that patient safety remains paramount, with the sandbox functioning as a controlled environment rather than an unregulated testing ground.

What are the next steps for developers and NHS providers?

The MHRA is now actively seeking medical device developers interested in participating in the next phase of the Manchester Sandbox programme. To facilitate collaboration, the agency plans to hold a joint roundtable meeting with MFT later in 2026 to “help shape the next wave of projects”. This engagement process is intended to align developer capabilities with NHS priorities, ensuring that technologies entering the sandbox address genuine clinical needs and can be scaled effectively if proven safe and effective.

NHS providers across Greater Manchester are expected to play a central role in hosting pilot deployments, providing clinical expertise and contributing real-world data to inform regulatory decisions. The collaborative structure is designed to reduce duplication of effort between developers and trusts, streamlining the path from prototype to routine care.

Background: How did the MHRA sandbox programme develop before Manchester?

The Manchester Sandbox builds on MHRA’s earlier regulatory innovation initiatives, including its centralised AI sandboxes and the AI Airlock programme launched in Spring 2024. In June 2026, MHRA announced the London Region I regulatory sandbox, which allows up to 10 AI-enabled medical device manufacturers to deploy technologies in live NHS clinical settings under MHRA oversight while generating real-world evidence on safety and effectiveness. The London initiative opened expressions of interest from AI medical device manufacturers and NHS providers in July 2026, establishing a template for regional expansion.

Alongside these clinical deployment sandboxes, MHRA launched a separate AI sandbox in June 2026 focused on using AI to improve medicines’ safety assessment and reduce reliance on animal testing, with up to five AI-driven approaches scheduled for testing and industry engagement beginning in summer 2026. These parallel tracks reflect MHRA’s broader strategy to modernise regulation for the AI era while maintaining rigorous safety standards. The Manchester launch in September 2026 represents the first regional extension of this model beyond London, signalling intent to replicate the approach in other UK regions.

Prediction: How could the Manchester sandbox affect patients, clinicians and medtech developers?

For patients in Greater Manchester, the Manchester sandbox could lead to earlier access to diagnostic and risk-stratification tools, potentially improving outcomes for long-term conditions through timelier interventions. Clinicians may benefit from decision-support technologies that integrate into existing workflows, reducing administrative burden and enhancing care personalisation, provided that usability and reliability are demonstrated during sandbox testing.

For medtech developers, particularly those building AI-enabled medical devices, the sandbox offers a structured pathway to generate real-world evidence under regulatory supervision, potentially accelerating NHS adoption if performance and safety thresholds are met. However, participation will require robust data governance, transparent algorithms and clear clinical value propositions to satisfy both MHRA oversight and NHS procurement criteria. If the Manchester model proves successful, similar regional hubs could emerge across the UK, creating a more distributed innovation ecosystem that balances speed of access with consistent safety standards.