Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, reports on the MHRA’s new project to support innovative diagnostic MedTech.
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new Early Access service to provide support 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 will 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 says it will “continue to work with industry, clinicians, NHS leaders and other partners to shape the pathway and support growth across the UK MedTech sector”.
The Author used AI in preparing this article, comments upon or questions about which can be addressed to chris.whitehouse@whitehousecomms.com.
