The UK Medicines and Healthcare products Regulatory Agency (MHRA) has invited applications from manufacturers and developers of artificial intelligence (AI) medical devices to participate in its ‘AI Airlock’ regulatory sandbox.
The scheme represents a significant advancement in the regulation of AI as a medical device (AIaMD), said the UK’s independent regulator of medical devices.
The initiative is aimed at assisting the MHRA in identifying and addressing the challenges associated with the regulation of AI medical devices. This will facilitate the timely and safe introduction of innovative solutions designed to benefit patients and the wider National Health Service (NHS).
AI Airlock programme participants will benefit from a customised testing plan designed to meet their specific needs, alongside opportunities for collaboration with industry and regulatory experts. This partnership aims to give entrants a deeper understanding of the existing regulatory framework and the data standards that must be adhered to for compliance.
The call for applications is open for two weeks, ending on 7 October 2024. The programme seeks to recruit candidates from various healthcare and clinical disciplines, encompassing a broad spectrum of regulatory challenges and stages of product and regulatory development.
To be considered eligible, applicants must demonstrate that their AI-driven medical device has the potential to provide benefits to patients and, consequently, the NHS. Additionally, the device must represent a novel or innovative application capable of presenting a regulatory challenge suitable for assessment within the Airlock pilot programme.
The findings derived from this pilot project are expected to inform subsequent AI Airlock initiatives and play a crucial role in shaping future guidance on AI medical devices at both the UK and international levels.
“Participation in the regulatory sandbox presents an opportunity for a proactive approach to product regulation, allowing developers and regulators to de-risk innovative products before entering the market,” said AI Airlock’s programme manager, Hannah Bowden.
This project is part of the MHRA’s ongoing commitment to developing a comprehensive regulatory framework for medical technology, said the regulatory body. It also stated that the focus remains on prioritising patient safety.
UK government keen on becoming AI sandbox central
MHRA’s initiative will also ensure patients have access to the necessary medical devices, support the transformation of the NHS, and reinforce the UK’s position as a desirable market for medical technology innovators.
Last year in April, the UK’s Financial Conduct Authority (FCA) confirmed that it would operate a permanent digital sandbox to help financial services companies to access synthetic data and thousands of fintech application programming interfaces (APIs). This initiative is aimed at supporting the development of innovative products and services as businesses incorporate more AI and other emerging technologies into their workflows.
Prior to this, in March, the UK government backed proposals for a new regulatory sandbox for AI models, tools, and systems. This multi-regulator sandbox is expected to aid innovators and entrepreneurs in testing new products or services under regulatory supervision without the risk of fines or liability.
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