Module 17 2024

05/12/2024

Chapter 10: Software as a Medical Device

Software and AI as a Medical Device Change Program – Roadmap List of Work packages: WP9 – AI RIG (AI Rigour)

WP10 – Project Glass Box (AI Interpretability) WP11 – Project Ship of Theseus (AI Adaptivity)

Each work-group has a number of sub-sections with individual deliverables. The MHRA will publish these deliverables in a stepped manner

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Chapter 10: Software as a Medical Device

In September 2024 the MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox. 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 unique collaboration with industry and regulatory experts, which will help them improve their understanding of the current regulatory framework and the expected data standards. Eligible candidates must demonstrate that their AI-powered medical device has the potential to benefit patients and, therefore, the NHS, is a novel or innovative application and can present a regulatory challenge that is ready to be tested in the Airlock pilot programme.

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