UK to Mandate Continuous Monitoring of AI-Based Medical Devices

The implementation plan will set out delivery targets and timelines for introducing the recommended regulatory changes across the National Health Service (NHS).

The UK will require AI-based medical devices to be monitored continuously after they receive approval for clinical use, shifting regulatory oversight beyond a single pre-market safety assessment, the head of the country's medicines regulator said Tuesday.

The UK government has accepted all 44 recommendations from a report examining how AI-based medical devices should be assessed and regulated. It plans to publish a full implementation plan by spring 2027, with a draft expected by the end of 2026.

The implementation plan will set out delivery targets and timelines for introducing the recommended regulatory changes across the National Health Service (NHS).

Lawrence Tallon, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), told Reuters that countries are increasingly approaching the UK to understand its regulatory approach to AI-based medical devices.

The regulatory shift comes as AI systems used in healthcare become more complex, including technologies that can change or adapt after deployment. Tallon said the sector is entering a more complex phase involving "non-deterministic algorithms," referring to AI systems whose outputs may vary or evolve as they are used by clinicians.

Under the planned approach, regulators will place greater emphasis on monitoring AI medical devices throughout their lifecycle rather than relying primarily on assessments conducted before they enter clinical practice.

The MHRA will also begin accepting applications for the third phase of its AI Airlock program. The initiative will focus on post-market surveillance and lifecycle monitoring of AI-based medical devices after they are introduced into clinical settings.

The UK has described its framework as the first comprehensive set of rules developed specifically for this emerging technology. The approach is intended to address regulatory challenges associated with AI systems that can evolve after deployment, requiring oversight to continue throughout their use.

The government's acceptance of all 44 recommendations sets the basis for the next phase of implementation, with further details expected in the forthcoming plan.

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