Key facts
- UK government will adopt all 44 recommendations from the National Commission into the Regulation of AI in Healthcare.
- MHRA will implement a proportionate, lifecycle-based framework for AI-enabled medical devices.
- MHRA to issue draft guidance by December 2026 on managing changes to AI-enabled medical devices.
- MHRA will consult on qualifying and classifying AI-enabled devices in early 2027.
- AI Airlock Phase 3, focusing on post-market surveillance, is funded until April 2029.
- The government committed to strengthening patient engagement and access to redress.
The UK government has committed to adopting all 44 recommendations put forth by the National Commission into the Regulation of AI in Healthcare. This comprehensive overhaul aims to create a more adaptive and proportionate regulatory framework for artificial intelligence in the healthcare sector.
The Medicines and Healthcare products Regulatory Agency (MHRA) will lead the implementation, shifting from a reliance on one-time assessments to a lifecycle-based approach for AI-enabled medical devices. This means devices will be monitored and assessed throughout their operational life as they evolve and improve.
Key initiatives include the MHRA issuing draft guidance by December 2026 on how to manage changes to AI-enabled medical devices over time. Furthermore, the agency will begin consulting in early 2027 on the qualification and classification of these devices. The government also plans to explore staged authorization pathways, allowing promising AI tools to be deployed in the National Health Service (NHS) earlier under close supervision while real-world evidence is gathered.
Beyond regulatory changes, the government has pledged to enhance patient engagement in decision-making processes, improve access to redress for patients when standards of care are not met, and ensure that the benefits of AI in healthcare are distributed equitably across all communities, including underserved groups. Patients will also be kept better informed about when AI is utilized in their care.
In parallel, the MHRA has opened applications for the third phase of its AI Airlock program, a regulatory sandbox designed for AI-enabled medical devices. This phase, funded until April 2029, will specifically focus on post-market surveillance and lifecycle regulation, collaborating with developers and healthcare partners to test safe monitoring and management of deployed AI devices. Priority topics for this phase include ongoing lifecycle assurance, surveillance in varied clinical oversight settings, and effective communication of device performance and safety information.