Medical artificial intelligence developers can apply to be part of the AI Airlock regulatory sandbox project operated by the Medicines and Healthcare products Regulatory Agency (MHRA).
The application process is open until October 7, 2024.
MHRA, the UK’s independent regulator of medical devices, is working towards a regulatory framework for medical technology that “prioritises patient safety, gives patients access to the medical devices they need and supports the NHS transformation”. The AI Airlock is a regulatory testing area - a sandbox - where MHRA will identify and address the challenges of regulating AI medical devices, it says. The aim is to ensure healthcare providers can adopt AI medical devices safely and quickly. In a statement, MHRA said AI medical technology developers would benefit: “During the AI Airlock programme, candidates will benefit from a bespoke testing plan and a unique collaboration with industry and regulatory experts, which will help them gain an improved understanding of the current regulatory framework and the data standards expected.”
It is anticipated that the findings of the AI Airlock will influence UK medical device guidance.
Organisations that want to be part of the AI Airlock have to be able to demonstrate that their AI medical device will deliver benefits to patients and the NHS, that it is a new application and will therefore pose regulatory hurdles to MHRA and that the AI device is ready to be tested within the AI Airlock.
MHRA said applications are open until October 7, 2024 and that it is looking for pilots that pose a wide range of regulatory challenges to different healthcare and clinical disciplines.
An application form is online.
