The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Statement of Policy Intent, which sets out initial thinking on a new Early Access service to help patients benefit sooner from innovative medical devices that address unmet clinical needs. 

The Early Access service will provide time-limited, conditional access to promising technologies ahead of full regulatory approval, where there is clear clinical need and supporting evidence of benefit for patients.

The scheme is designed to support innovators, including small and medium-sized enterprises, and aims to help bring safe and effective medical devices to patients more quickly.

The focus will initially be on innovative diagnostic devices, particularly those supporting the NHS's most urgent needs.

The Early Access service will use learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP), and be shaped by stakeholder engagement with key sector representatives.