UK to continuously monitor AI-based medical devices after approval
UK to continuously monitor AI-based medical devices after approval
The UK plans to monitor AI-based medical devices not only before they are approved, but also after they begin being used in hospitals and clinics.
The reason is that some modern AI systems can learn from new data and change how they operate over time. This means that a single safety assessment before approval may no longer be enough.
The UK government has said it will accept all 44 recommendations proposed for regulating AI-based medical technologies.
The new approach will include:
- monitoring AI medical devices throughout their lifecycle;
- assessing their safety and performance after they enter clinical practice;
- identifying possible problems or changes in AI behaviour at an early stage;
- gradually introducing the new requirements across the NHS.
A draft implementation plan is expected by the end of 2026, with a full implementation plan due by spring 2027.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will also open a new phase of its AI Airlock programme, focusing specifically on post-market surveillance and ongoing monitoring of AI medical devices.
According to Reuters, the UK is developing a comprehensive regulatory approach for this rapidly evolving technology, with other countries also showing interest in learning from its experience.