What happened
On 10 September 2026, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) published the National Commission into the Regulation of AI in Healthcare's report, 'Recommendations for a future regulatory framework.' The Commission, chaired by NHS clinicians, sets out a blueprint intended to accelerate safe AI adoption in the NHS and reshape how AI-enabled medical devices and software are regulated in the UK.
Why it matters
This is an authoritative, government-commissioned review that will shape the UK's future statutory and regulatory framework for AI-enabled medical devices/software — a sector-specific but consequential AI governance track that MedTech and digital-health AI developers/deployers should track closely as MHRA moves from recommendations toward implementation.
Action needed
Digital-health and MedTech AI developers targeting the UK market should review the Commission's recommendations and begin aligning product development/regulatory-affairs planning with the proposed future framework ahead of any formal MHRA rulemaking.