The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has secured a major funding boost to expand its AI Airlock programme, the country’s first regulatory sandbox for artificial intelligence as a Medical Device (AIaMD). The Department of Health and Social Care (DHSC) has committed Euro 1.2 million annually over the next three years, taking the total investment to Euro 3.6 million for the 2026–2029 period. 

The new multi-year funding is expected to significantly strengthen the programme by allowing it to move beyond annual budget cycles and support more ambitious, long-term testing models. This is expected to create a more sustainable and predictable regulatory pathway for future AI-powered medical technologies. 

Launched in spring 2024, AI Airlock was developed by the MHRA in partnership with DHSC, the NHS AI Team and Team AB, the consortium of UK Approved Bodies. The initiative provides a controlled environment where developers can work directly with regulators to test innovative AI tools before they reach patients.

The programme has become a key part of the UK’s wider healthcare AI strategy and aligns with government priorities under the AI Opportunities Action Plan, Regulatory Action Plan and long-term health and life sciences programmes. The MHRA said the initiative is helping shape a future-ready regulatory framework that balances patient safety with innovation. 

Since its launch, AI Airlock has identified several emerging regulatory challenges linked to AI medical devices. Early findings from the pilot phase highlighted the need for better risk management practices, improved explainability of AI recommendations for clinicians and stronger post-market monitoring systems to detect performance shifts or over-reliance by users. 

The second phase of the programme, which began in 2025 and runs through April 2026, is focused on challenges such as AI-powered diagnostics, pre-determined change control plans and evolving intended use cases. It includes a broad mix of technologies such as large language models, voice-based tools, cancer diagnostics and rare disease applications. Phase two findings are expected to be published in summer 2026 and will help shape the design of phase three. 

Industry participants have welcomed the funding extension, saying the AI Airlock offers a valuable platform for collaboration between developers and regulators. The programme is also contributing insights to the National AI Commission’s work on the future of healthcare AI regulation. 

With the latest investment, the MHRA aims to strengthen patient safety, support responsible AI innovation and reinforce the UK’s position as a leading market for medical technology development.