The MHRA has provided an update on its AI regulatory sandbox initiative, giving details of the pilot phase, how to apply and the impact it hopes to achieve for AI market access and future regulation.

The AI Airlock was announced at the end of 2023 as a tool to help developers bring innovative medical technology to market. It is being run in partnership with NHS England, NHS AI Labs, and DHSC.

The AI Airlock will create a collaborative environment which can improve understanding of the regulatory challenges associated with integrating AI medical devices into the NHS. It is an opportunity for products developers to create strong relationships with key regulatory and NHS stakeholders, as well as understand the likely direction of future AIaMD regulation. 

The AI Airlock is designed to help ensure that AI devices will be safe, robust and useful as part of their path to adoption by the NHS. By testing products against real-world scenarios in a sandbox environment, developers and stakeholders can explore innovation boundaries without putting patients at risks. 

The products will still need to go through the usual regulatory approval, evidence collection and economic assessments as part of their route to market, but the AI Airlock is intended to de-risk this journey by involving key stakeholders in product development from an early stage. 

The MHRA also hopes the AI Airlock will help to find solutions for regulatory issues related to interpretability, reproducibility and explainability, as well as gaining the trust of healthcare professionals and patients.  

There will be different types of Airlock used to test products, ranging from simulations used to inform theoretical discussions, to running real data in a virtual environment and even deploying products in  a healthcare setting and carrying out clinical investigations (which may require a separate MHRA safety assessment). 

Pilot phase 

The MHRA are looking for a range of product types from different clinical areas at various stages throughout a product lifecycle, with 4-6 applicants to be selected for the first pilot phase. This is expected to run until April 2025 and will inform future phases. 

During the pilot, participants will form a product team and select a case manager. The programme will be governed by a governance board composed of internal and external stakeholders.

The results of the pilot will be analysed by a supervisory committee and programme evaluation partner to inform the next phase and feed into future regulatory guidance. 

Applications

The call for applications opens after summer. The application form will be available on the AI Airlock website. Applicants are not limited to new products. Products which have received regulatory approval in other jurisdictions can still apply.

If you would like to discuss any issues relating to digital health products, medical device regulation or market access, please contact a member of our Health Tech team. 

This article was written by Rory Trust and Abigail Cropper.