The MHRA has responded to the recent NHS 10-Year Plan and Life Sciences Sector Plan by releasing a Statement of Policy Intent designed to speed up NHS access to innovative diagnostics which address unmet clinical needs.
The statement sets out the MHRA’s initial thinking on an Early Access service which will be developed further over the coming months. Initially, it will focus on innovative diagnostic devices, particularly those which address unmet clinical needs or can significantly improve patient outcomes. The service will adopt learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP) and is shaped by stakeholder engagement with key sector representatives.
The UNCA will be repurposed to be made available to innovators outside of an innovation pathway such as IDAP, enabling patients to receive faster access to medical technologies.
It also aims to help innovators to gather evidence on their devices in real world environments, therefore bridging the gap between clinical investigation and full regulatory approval.
In addition to the Early Access service, the document outlines further measures to enable improved MedTech access including an expansion of international reliance routes, advice services and regulatory sandboxes.
Crucially, the agency states that it will link the Early Access service with other government initiatives designed to improve MedTech adoption in the NHS.
By taking advantage of these strategic opportunities — transforming regulatory assessments into streamlined, risk-proportionate services, expanding access to aforementioned early access services, and make real-world data generation simpler and more accessible — the agency seeks to position the UK as global leaders in medical device innovation.
The MHRA will consult with stakeholders, including BIVDA, before launching the Early Access service. In the meantime, if you have general queries about this statement of policy intent, please contact info@mhra.gov.uk.
