The pilot project will help the MHRA identify and address the challenges for regulating AI medical devices so that in the future, innovative and safe AI medical devices can be brought safely into use in the shortest time possible, for the benefit of patients and the NHS.

During the AI Airlock programme, candidates will benefit from a bespoke testing plan and a collaboration with industry and regulatory experts, which will help them gain an improved understanding of the current regulatory framework and the data standards expected.

The call for applications is open for two weeks until 7 October and will provisionally recruit candidates into the pilot covering a wide range of regulatory challenges, from different healthcare or clinical disciplines, and at various stages of product and regulatory development.

The project is part of the MHRA's continuing work to develop a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need, supports the NHS transformation and ensures the UK becomes an even more attractive market for medical technology innovators.

Hannah Bowden, AI Airlock programme manager, said: ‘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.'