Regulatory body for medical equipment to unveil Early Access program, designed to foster quicker implementation of groundbreaking devices
MHRA Launches Early Access Service for Innovative Diagnostic Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new Early Access service, designed to provide controlled, time-limited, and conditional access to promising medical devices that address unmet clinical needs and improve patient outcomes in Great Britain.
This service, which is part of a broader programme of regulatory reform, aims to enable earlier patient access to safe and effective innovations, particularly diagnostic devices supporting the NHS's most urgent needs, before full regulatory approval is granted. The Early Access service is intended to support innovators, including small and medium-sized enterprises, by accelerating access to cutting-edge technologies under clear clinical need and with supporting evidence of patient benefit.
This initiative is a significant step towards the UK Government’s Life Sciences Sector Plan and the 10-Year Health Plan, aligning with the UK's ambition to become a global leader in medical device innovation. The MHRA Early Access service builds on experience from the Unmet Clinical Need Authorisation (UCNA) tool piloted under the Innovative Devices Access Pathway (IDAP), with ongoing stakeholder engagement to refine and shape the pathway.
The Early Access service will initially focus on innovative diagnostic devices, particularly those supporting the NHS's most urgent needs. It is expected to foster innovation within the UK MedTech industry by enabling earlier introduction of promising technologies while maintaining a focus on safety and effectiveness.
The MHRA, as an advisor to MedTech suppliers, is poised to become a global leader in risk-proportionate regulation of MedTech. This initiative is part of a wider programme of regulatory reforms that include enhanced post-market surveillance and greater international collaboration. The MHRA commits to working with industry, clinicians, NHS leaders, and other partners to support the growth of the UK MedTech sector through this program.
The MHRA's Early Access service has received attention from experts like Chris Whitehouse, a political consultant and expert on medical technology policy and regulation. For more information about Chris Whitehouse, he can be contacted at [email protected].
It is worth noting that UKCA markings are no longer in use, and CE marked devices will be indefinitely recognized. The MHRA has also launched a stakeholder survey under the Medicines and Medical Devices Act 2021 to gather insights and shape the direction of the Early Access service.
In summary, the MHRA Early Access service plays a critical role in accelerating patient access to innovative diagnostic medical devices, addressing clinical gaps, and fostering innovation within the UK MedTech industry by enabling earlier introduction of promising technologies while maintaining a focus on safety and effectiveness.
Medical-condition diagnosis could potentially be improved through the use of innovative diagnostic devices, as the MHRA's Early Access service focuses on facilitating their introduction. This service, aiding science-backed device innovation, aligns with the UK's ambition to lead in the medical-conditions sector, thereby enhancing health-and-wellness.
