UK – MHRA’s AI Airlock to address challenges for regulating AI medical devices

The sandbox will help to inform future AI Airlock projects and influence future AlaMD guidance

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices that use artificial intelligence (AI).

In alignment with the regulator’s goal for the UK to be a science and technology superpower by 2030, the new sandbox builds on the MHRA’s strategic approach to AI in April, which was set out to respond to a white paper published by the government in 2023…