A UK independent commission convened by the Medicines and Healthcare products Regulatory Agency has proposed a new framework for AI-enabled medical devices. Its recommendations include supervised, staged authorisations for new models, continuous real-world monitoring throughout a product's life, and a public way to inspect safety information and adverse incidents.

The commission says its work drew on evidence from more than 12,000 people, including patients, clinicians and developers. These are recommendations rather than enacted rules: the government and MHRA said they will consider them and respond formally. The proposal therefore signals regulatory direction, not an immediate change in approval law.

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This is an original summary, not a republication of the full report.

Read the original at UK MHRA ↗

Primary statement: National Commission into the Regulation of AI in Healthcare ↗