AI Airlock pilot call for applications (closed)

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with the Department of Health and Social Care and the NHS AI Lab, launched the AI Airlock pilot program to foster the development of Artificial Intelligence as a Medical Device (AIaMD). This initiative follows the UK Medical Devices Regulations 2002 framework and is designed as a regulatory sandbox. The application window for this pilot closed on October 7, 2024, following an initial launch in July. The MHRA sought to recruit a cohort of 4 to 6 candidates whose innovative products present significant regulatory challenges within the healthcare system. The pilot aims to address issues surrounding the medical device lifecycle, such as data access, quality management systems, and clinical documentation requirements. Participating companies are required to commit resources to a bespoke testing plan, which must be completed within a six-month timeframe. While there are no fees to join the program, candidates must fund their own studies and data acquisition. The pilot phase is scheduled to conclude in April 2025. The outputs of these collaborations—including project reports and a broader sandbox learning report—will be used to influence future regulatory guidance and help de-risk innovative AI products before they enter the UK market. This proactive approach ensures that transformative technologies can safely navigate complex regulatory hurdles while providing clear benefits to public health.