MHRA launches AI Airlock regulatory sandbox to help identify challenges for regulating AI medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of its regulatory sandbox for AI as a Medical Device (AIaMD), AI Airlock, a pilot project which forms a “key part” of the agency’s recently published strategic approach to AI.

In what will initially involve the support of 4-6 virtual or real-world projects, AI Airlock is hoped to help the agency to “identify and address the challenges for regulating standalone AI medical devices (AIaMD)”, enabling the testing of regulatory issues for devices when in use for clinical purposes in an NHS setting.

Taking into account evidence-based work from other similar bodies, the MHRA plans to collaborate with the NHS AI Lab and the DHSC, and states that findings from partnerships with government, regulators and industry “will inform future AI Airlock projects and influence future UK and international AIaMD guidance, including how we work with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices”.

Dr Paul Campbell, head of software and AI at the MHRA, spoke of the “marked increase in innovative AIaMD products entering the UK market”, adding: “As a regulator, we must balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure we continue to be an enabler for innovation. The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients.’’

​A dedicated AI Airlock webpage shares the most recent updates on progress, and highlights that applications will be open following a project webinar scheduled for 5 June, adding that applications will be prioritised against the application criteria.

The webpage adds that “successful applicants to the AI Airlock will be required to work collaboratively and transparently with the project team”, producing reports, detailing outcomes, and sharing “lessons learnt to inform regulatory policy and guidance”.

To learn more about the AI Airlock project, please click here.

Back in January, the MHRA published its Regulatory Roadmap, intended to “protect patient safety and enable access without delay for UK patients to innovative medical technologies” including implantable devices, healthcare AI and software, and diagnostics for the early detection and prevention of disease.

Elsewhere, Microsoft AI recently announced plans to launch a new Microsoft AI hub in London, marking “significant, long-term investment” in the region and a push to hire “the best AI scientists and engineers” in the field.