The Medicines and Healthcare products Regulatory Agency published the report of the National Commission into the Regulation of AI in Healthcare on 10 September 2026. The Commission was set up in September 2025 and is chaired by Professor Alastair Denniston. It gathered evidence from more than 12,000 people over the course of a year. The publication sets out recommendations for future regulation, and a cross-government response is to follow separately.
The publication is titled National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework and is issued as research and analysis. It is not a statutory instrument and not guidance with legal effect. It carries no commencement date and imposes no obligation on its own. Any change to the rules governing AI-enabled medical devices in the United Kingdom would come through the government response and then through legislation or MHRA guidance.
Developers of AI-enabled medical devices and the NHS organisations deploying them are the parties the recommendations reach. The Commission asks for staged authorisations for new AI models, described in the announcement as similar to L-plates, with close supervision before fuller authorisation. It also asks that AI-enabled medical devices be subject to continuous, real-world monitoring throughout their working life rather than a single point-in-time approval.
Three further recommendations bear on disclosure and enforcement. Members of the public should be able to search for information about the safety of specific AI-enabled medical devices, including any adverse incidents. Patients should know when AI is being used in their care. The MHRA should hold stronger powers, including enhanced enforcement powers. No deadline attaches to any of this, and the timing rests with the cross-government response.
Licentium advises health technology developers, deployers and investors on AI regulation in the United Kingdom and the European Union. Work we undertake includes regulatory classification of AI-enabled medical devices, post-market surveillance and vigilance obligations, patient-facing transparency drafting, and responses to consultations on AI rules.