Five innovative technologies have been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for the AI Airlock, a pilot scheme to better understand how to regulate artificial intelligence (AI) powered medical devices in a way that that enables getting these types of products to the NHS and patients who need them as quickly and safely as possible.
These novel medical devices have the potential to significantly improve the diagnosis and care of patients. Those selected for the pilot include medical devices for cancer and chronic respiratory disease patients as well as those requiring radiology diagnostic services
AI Airlock is a regulatory “sandbox”, a type of study where manufacturers can explore how best to collect evidence that could later be used to support the approval of their product. This is done under MHRA supervision in a virtual or simulated setting. Doing so will help the manufacturer and the MHRA better understand the challenges of regulating AI in medical devices, leading to a more bespoke and enabling regulatory framework, a clearer route to market for industry and, most importantly, paving the way for quicker NHS and patient access to potentially transformative AI technologies.
Being selected for AI Airlock does not constitute a regulatory approval. The findings from the pilot, due to be announced in 2025, will inform future AI Airlock projects and influence future UK AI Medical Device guidance. For example, the findings are likely to influence how the MHRA works with UK Approved Bodies on UKCA marking and improve the framework of support for manufacturers developing these types of products.
The MHRA’s AI Airlock aims to addresses the Darzi report’s call for regulatory frameworks that enable the development and implementation of innovative AI medical devices to ensure they are safe and perform as intended. It forms part of the UK regulator’s overhaul of the medical device regulations.
