Medicines Healthcare Products Regulatory Agency
Today, Monday 23 September, the MHRA, the UKs independent regulator of medical devices, is calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulatory sandbox.
The AI Airlock is a world leading regulatory sandbox for AI as a Medical Device (AIaMD). This pilot project will help the MHRA identify and address the challenges for regulating AI medical devices so that in the future, innovative and safe AI medical devices can be brought safely into use in the shortest time possible, for the benefit of patients and the NHS.
During the AI Airlock programme, candidates will benefit from a bespoke testing plan and a unique collaboration with industry and regulatory experts, which will help them gain an improved understanding of the current regulatory framework and the data standards expected.
The call for applications is open for two weeks until Monday 7 October and will provisionally recruit candidates into the pilot covering a wide range of regulatory challenges, from different healthcare or clinical disciplines and at various stages of product and regulatory development.
Eligible candidates must be able to demonstrate that their AI-powered medical device has the potential to deliver benefits to patients and therefore the NHS, is a novel or innovative application, and can present a regulatory challenge that is ready to be tested in the Airlock pilot programme.
The findings will inform future AI Airlock projects and influence future UK and international AI Medical Device guidance.
The project is part of the MHRAs continuing work to develop a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need, supports the NHS transformation and ensures the UK becomes an even more attractive market for medical technology innovators.
AI Airlock programme manager Hannah Bowden 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.
Full details and an application form is online, and my team is available to answer questions from potential applicants by email at: a