Module 17 2024

05/12/2024

Chapter 10: Software as a Medical Device

Software and AI as a Medical Device Change Program – Roadmap The programme includes eleven work packages across two workstreams. The first stream contains eight work packages to make key reforms across the software as a medical device (SaMD) lifecycle. The second stream has three work packages and considers the challenges that AI as a medical device (AIaMD) can pose over and above classically programmed software. Some (but not the majority) of the changes intended will be in the form of secondary legislation, these have been consulted upon as a part of the previous consultation process. Much of the programme builds upon legislation through guidance, for instance, by clarifying what medical device requirements mean in the context of software and AI.

The Organisation for Professionals in Regulatory Affairs

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Chapter 10: Software as a Medical Device

Software and AI as a Medical Device Change Program – Roadmap List of Work packages: WP1 –Regulatory Guidance WP2 –Classification WP3 –Premarket Requirements WP4 – Post Market WP5 – Cyber Secure Medical Devices

Work packages 6, 7 and 8 do not have discrete deliverables assigned to them in this programme. The content of these work packages has been absorbed into wider SaMD and AIaMD deliverables outlined in this programme.

The Organisation for Professionals in Regulatory Affairs

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