Regulatory body plans to unveil Early Access program, aiming to accelerate adoption of groundbreaking medical equipment.
MHRA Announces New Early Access Service for Innovative Diagnostic MedTech
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new Early Access service, designed to support innovators, including small and medium-sized enterprises, by providing time-limited, conditional access to promising medical technologies before full regulatory approval.
This service, a key part of the UK Government’s Life Sciences Sector Plan (LSSP) and the 10-Year Health Plan, is targeted at devices that address unmet clinical needs within the National Health Service (NHS). Initially, the focus will be on innovative diagnostic devices critical to the NHS's urgent healthcare and financial priorities.
The Early Access service allows manufacturers to supply these innovative devices to the NHS under controlled conditions, enabling patients to benefit from cutting-edge medical technology more quickly. While the devices are in use, innovators can gather real-world evidence to support full regulatory approval.
This service bridges the gap between clinical investigation and obtaining full regulatory clearance and is developed from a pilot tool called the Unmet Clinical Need Authorisation (UCNA), part of the Innovative Devices Access Pathway (IDAP).
The Early Access service aims to accelerate patient access to innovative diagnostics, support NHS sustainability by enabling earlier adoption of technologies potentially reducing long-term costs, promote UK leadership in MedTech innovation, attract investment, and encourage development through regulatory reforms and collaboration. It also provides a framework to gather real-world evidence facilitating full regulatory approval, helping innovators scale up effectively.
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. The service will complement other regulatory reforms, including enhanced post-market surveillance and increased international collaboration, to strengthen the UK MedTech ecosystem.
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation, is reporting on the MHRA's new project to support innovative diagnostic MedTech.
In summary, the MHRA Early Access service is a targeted, conditional pathway allowing earlier use of innovative diagnostic medical devices in the NHS. It supports the UK’s broader health and economic strategies for innovation-led improvements in care delivery and life sciences sector growth.
- This Early Access service, a part of the UK's Life Sciences Sector Plan and 10-Year Health Plan, is focusing on device innovation within medical-conditions, specifically with diagnostic devices addressing unmet clinical needs within the NHS, to foster health-and-wellness improvements and MedTech innovation.
- The MHRA's Early Access service, designed to escalate patient access to innovative diagnostics, promotes UK leadership in medical device innovation, urges investment, and encourages development through regulatory reforms, collaboration, and real-world evidence gathering, thereby strengthening the UK MedTech ecosystem.
