MHRA's AI as medical device pilot opens for applicants

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory pilot.

Called the AI Airlock, the pilot was unveiled earlier this year with the aim of bringing together regulatory authorities, developers, and other organisations such as the NHS and Department of Health and Social Care (DHSC) to identify and address the challenges of regulating AIaMD technologies.

The idea is to create a regulator-monitored virtual area for developers to generate evidence for their devices so they can be "brought safely into use in the shortest time possible, for the benefit of patients and the NHS," said the MHRA in a statement.

The pilot project is expected to involve between four and six projects and run until April 2025 and will initially focus on a small number of products "across a range of medical device regulatory issues, within different sections of healthcare or clinical disciplines and levels of product regulatory maturity," according to the regulator.

Dr Paul Campbell, head of software and AI at the MHRA, said in a recent webinar that AIaMD has the potential to "fix some of the broken bits" of the UK health system, but that will be dependent on the products being "safe, reliable, and robust" and able to work alongside existing NHS processes.

The AI Airlock is designed to ensure that they can fulfil those requirements, and help inform an ongoing process to update regulations on guidance covering medical devices, software as a medical device (SaaMD), and AIaMD, according to Campbell.

While the programme predates the new Labour government in the UK, its objectives tie in with the drive to digitise the NHS, which was highlighted in the recently published Darzi report as one of three key recommendations, alongside more care in the community and a greater emphasis on disease prevention.

"Participation in the regulatory sandbox presents an opportunity for a proactive approach to product regulation, allowing developers and regulators to de-risk innovative products before entering the market," commented AI Airlock's programme manager, Hannah Bowden .

The call for applications is open for two weeks until Monday 7th October. Eligible candidates must be able to demonstrate that their AIaMD has the potential to deliver benefits to patients and the NHS, is a novel or innovative application, and poses a regulatory challenge that is ready to be tested in the pilot programme.