Statement of Policy Intent 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 Medicines and Healthcare products Regulatory Agency (MHRA) is setting out its intention to enable earlier access to innovative medical devices that address unmet clinical needs within the NHS. As part of this, capability will be invested to establish a new Early Access service to 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.
Designed to support innovators, including small and medium-sized enterprises, the Early Access service aims to help bring safe and effective medical devices to patients more quickly. Focus initially will be on innovative diagnostic devices, particularly those supporting the NHS's most urgent needs.
This forms part of the MHRA's wider contribution to the UK Government's Life Sciences Sector Plan and the 10-Year Health Plan, and supports the UK's ambition to be a global leader in medical device innovation.
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.
The initiative sits within a broader programme of regulatory reform, including strengthened post-market surveillance and increased international collaboration. The MHRA will continue to work with industry, clinicians, NHS leaders and other partners to shape the pathway and support growth across the UK MedTech sector.
