Summary
Recommends a future framework for software and AI-enabled medical devices, including risk-proportionate classification, staged authorisation, lifecycle evidence and monitoring, clearer accountability across manufacturers and health systems, and greater transparency for patients. It advises government and MHRA; it does not change current law.
Healthcare Implications
Could shape future UK medical-device regulation, authorisation pathways, supplier evidence, healthcare-organisation governance, post-market monitoring, and patient disclosure. Developers and providers may use the proposals for planning, but they impose no present obligations.