New Delhi: Artificial intelligence (AI) medical devices could be brought into the UK market more quickly following the launch of a regulatory sandbox by the Medicines and Healthcare Products Regulatory Agency (MHRA), a UK government release stated.
The MHRA is calling for manufacturers and developers of AI medical devices to submit applications to join the AI Airlock regulatory sandbox, which was developed to help identify and address regulatory challenges in the area. The sandbox will provide a testing plan for products and allow developers to collaborate with industry and regulatory experts.
This is part of the regulatory authority’s continuing work “to develop a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need,” aiming to support the National Health Service (NHS)’s transformation to ensure the UK becomes an more attractive market for innovators in medical technology .
The AI Airlock programme aims to encourage the development of innovative and safe AI medical devices that can be brought to market more quickly, for the benefit of patients and the NHS. 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.”
The call for applications is open for two weeks, with the MHRA stating that it will provisionally recruit candidates to the pilot scheme from a range of healthcare and clinical disciplines.