In the latest step towards the full integration of artificial intelligence-powered medical devices into the NHS, the Medicines and Healthcare products Regulatory Agency is calling on manufacturers and developers to join the AI Airlock regulatory sandbox.
The project has been designed to help the MHRA identify and ultimately tackle the challenges surrounding the regulation of AI medical devices so the sharp end of AI innovation can be introduced into the NHS as quickly as possible.
Opportunity for proactivity
The pilot was announced last October, with the aim of ensuring innovators actually develop products with real-world use – with this in mind, participants will benefit from bespoke testing plans and unique partnerships with industry and regulatory experts.
Hannah Bowden, AI Airlock programme manager, said: “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.”
Eligible candidates must be able to show their AI-powered medical devices:
- have the potential to deliver benefits to patients;
- are novel or innovative applications; and
- are ready to test a regulatory challenge.
National and international Importance
The call for applications is open until the 7th of October and will provisionally recruit candidates to encompass a wide variety of regulatory issues.
The findings from this particular stage of the project will inform future AI Airlock projects while also influencing national and international AI guidance.
It is all a part of the MHRA’s wider work to develop a MedTech framework that centres around patient safety, access and innovation.
This comes shortly after central government announced a series of AI projects that will help the NHS unlock underused capacity, cut carbon emissions and improve patient experience.
For more on AI in the NHS, read the latest edition of the National Health Executive digital magazine and explore the Health Foundation’s perspective on why the health system needs a dedicated AI strategy.
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