Medicines and Healthcare products Regulatory Agency pilot new regulatory approach for Artificial Intelligence (“AI”) technologies

Pilot Scheme: AI Airlock

The Medicines and Healthcare products Regulatory Agency (MHRA) continue work on transforming the regulatory approach for innovative AI technologies. The AI Airlock pilot scheme is helping test and improve the rules for AI medical devices to streamline their route to market. 

Five novel medical devices have been selected by the MHRA for the AI Airlock pilot scheme. The nature of AI technologies is challenging from a regulatory perspective, because it is difficult to show evidence that a technology is safe and effective where an AI medical device changes as it learns. 

The goal of the AI Airlock pilot scheme is to facilitate a bespoke and enabling regulatory framework with a clearer route to market for manufacturers, which in turn allows these innovative AI technologies to reach patients and improve patient outcomes quicker. 

The outcomes of the AI Airlock pilot scheme will be announced in 2025 and will inform future AI Airlock projects as well as influence future UK AI Medical Device regulatory guidance. The findings are likely to influence how the MHRA work with UK Approved Bodies on UKCA marking and improve the framework of support for manufacturers developing AI powered medical devices. 

The AI revolution has been touted to have a potentially transformational impact on healthcare, which has been recognised by the Labour government, which has pledged to boost growth by making UK a “great AI superpower”. However, this expansive approach with AI should be balanced with the need to protect data and retain control of it, rather than letting health data be put into the hands of private organisations without adequate controls as to its use. The AI Airlock pilot scheme addresses the call for regulatory frameworks that enable the development and implementation of innovative AI medical devices to ensure that they are safe and perform as intended. The AI Airlock pilot scheme also forms part of MHRA’s wider mandate for updating the medical device regulatory framework. 

More information about the five novel medical devices selected can be found here.

How we can help

Should you wish to discuss any issues relating to liability exposure, medical device regulation and commercialisation of new digital health and medtech solutions; please contact:

Vincent Buscemi 
Louise Brennan