MHRA Announces Initiative to Accelerate Patient Access to Innovative Medtech

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is working to enable earlier access to innovative medical devices that address unmet clinical needs within the National Health Service. As part of this, the MHRA plans 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 patient benefit.

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, according to the MHRA.  

This forms part of the MHRA’s wider contribution to the U.K. government’s Life Sciences Sector Plan and the 10-Year Health Plan, and supports the country’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 program 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 U.K. medtech sector.