UK commission proposes staged approval for medical AI with post-deployment oversight

UK commission proposes staged approval for medical AI with post-deployment oversight

On 10 September, the National Commission on the Regulation of AI in Healthcare published 44 recommendations for a future UK regulatory framework. The recommendations are addressed to the Medicines and Healthcare products Regulatory Agency (MHRA), the government, and healthcare organizations.

Medical AI can change after updates and perform differently across clinical settings: outcomes depend on the data, workflows, and conditions of use at each site. The current UK system for assessing the safety and performance of medical devices places greater weight on pre-deployment evidence, and post-market surveillance relies largely on incident reports. The commission's report proposes collecting evidence and maintaining oversight throughout the entire lifecycle of a system.

Under Recommendation 14, MHRA could initially authorize a device only under specified conditions of use, following a review of baseline data, risk control measures, and reporting requirements. The scope of use could later expand once the system meets predefined safety and performance thresholds. The provisional nature of such authorization should be made clear to patients, and the pathway to full authorization should be described in advance.

After deployment, the commission proposes requiring surveillance plans, real-world performance studies, and periodic reporting on how devices are performing. If performance deteriorates, a defined escalation procedure should apply. A separate recommendation proposes recording the device identifier and its version in the patient's medical record. This would allow clinicians and healthcare facilities to audit outcomes for patients whose care involved a specific system.

The commission links safety to how a clinical site introduces the technology into practice. Manufacturers would need to describe the conditions for safe use in advance, including user training and site readiness. A contract between the manufacturer and the clinical site should allocate responsibility for these measures, and sites would also need to train their staff to work with the specific technology.