MHRA launches regulatory sandbox for AI medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new regulatory sandbox called AI Airlock to address the challenges around regulating medical devices that utilize artificial intelligence (AI). This initiative is specifically focused on AI as a medical device (AlaMD) products. The AI Airlock will provide a platform for manufacturers to safely develop and deploy AIaMDs, ensuring their real-world viability. Dr. Paul Campbell, head of software and AI at MHRA, highlighted the potential of innovative AlaMD products entering the UK market and how the AI Airlock will enhance understanding and accelerate solutions to novel regulatory challenges. Collaborating with the NHS AI Lab and the Department of Health and Social Care, as well as considering evidence-based work from other organizations, MHRA aims to influence future UK and international guidance on AIaMDs. This strategic initiative aligns with MHRA’s recent regulatory roadmap for the development of new regulations for medical devices in the UK.