Applications have now opened to join the MHRA’s AI Airlock pilot. You must submit your application before 7 October 2024.
The application process is designed to gather information about AI Medical Devices (AIaMD) and prototypes and evaluate their suitability for the AI Airlock pilot. They MHRA are seeking to recruit 4-6 candidates to form the pilot cohort that cover a wide range of regulatory issues, healthcare or clinical disciplines and levels of product and regulatory development.
During the Airlock programme, candidates will benefit from a unique collaboration of industry and regulatory experts, a bespoke testing plan and gain an improved understanding of the current regulatory framework. Participation in the regulatory sandbox presents an opportunity for a proactive approach to AIaMD regulation, derisk the innovative products ahead of entering the market and may benefit future routes to market.
Outputs of the Airlock programme will include Project Reports from each candidate project team, an Airlock Sandbox report of learnings to inform future guidance and implications for the regulatory framework, and a programme evaluation report sharing learnings on the use of regulatory sandboxes.
You must complete the application form and return to the aiairlock@mhra.gov.uk mailbox to submit a proposal to the AI Airlock.
