MHRA Secures $4.8 Mn to Scale AI Airlock Programme for AI Medical Devices

The current phase of AI Airlock is focused on regulatory issues related to AI-powered diagnostics, pre-determined change-control plans, and expanded indications for medical devices.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has secured USD 4.8 Mn (GBP 3.6 Mn) in funding to expand its AI Airlock programme, significantly increasing support for the UK’s regulatory framework for AI as a medical device (AIaMD).

The investment will fund the initiative through 2029 and allow the regulator to broaden testing and evaluation of AI-driven healthcare technologies.

The AI Airlock programme was launched as the UK’s regulatory sandbox for AI medical devices, designed to help regulators and developers assess novel technologies in controlled real-world settings before broader deployment.

Jointly operated by the MHRA, Department of Health and Social Care (DHSC), NHS AI Team, and Team AB, the consortium of UK Approved Bodies, the programme has become a central part of the UK’s evolving strategy for AI regulation in healthcare.

Under the new funding arrangement, the DHSC will provide GBP 1.2 Mn annually from 2026 to 2029.

According to the MHRA, the multi-year commitment removes the limitations of short-term annual budgeting and creates capacity for larger and more sustained regulatory evaluations.

Pilot Findings Highlight AI Regulatory Challenges

Since its pilot launch in 2024, AI Airlock has been used to examine the regulatory complexities associated with AI-enabled medical technologies.

Early programme findings highlighted that AI medical devices require risk management approaches tailored to the unique characteristics of machine learning systems, particularly in reducing errors and inaccuracies through techniques that anchor outputs to validated clinical data.

The pilot phase also underscored the importance of post-market surveillance, with regulators emphasizing the need for continuous monitoring after deployment to identify shifts in model performance and mitigate risks such as overreliance by clinicians or users.

Current Focus includes Diagnostics & LLMs

The current phase of AI Airlock is focused on regulatory issues tied to AI-powered diagnostics, pre-determined change control plans, and expanded indications for medical devices. It has reviewed technologies spanning voice-based clinical tools, large language models, and AI diagnostics for cancer and rare diseases.

Insights from this phase are expected to be published in mid-2026 through reports and case studies intended to guide both developers and regulators.

MHRA innovation and compliance executive director James Pound said: “Securing this multi-year funding boost marks a pivotal moment for AI Airlock and for the safe and responsible advancement of AI in healthcare.

The funding announcement comes as the MHRA continues to expand its broader medical device oversight efforts, having reported record device trial approvals in the UK last year.

The investment also aligns with wider UK government priorities around healthcare innovation, including the Regulatory Action Plan, AI Opportunities Action Plan, 10-Year Health Plan, and Life Sciences Sector Plan.

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