Regulatory body to initiate Early Access program, accelerating the integration of groundbreaking medical equipment
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new Early Access service, a regulatory scheme designed to expedite the availability of innovative diagnostic medical devices ahead of full regulatory approval [1]. This initiative is part of a broader programme of regulatory reform, including strengthened post-market surveillance and increased international collaboration [8].
The Early Access service is intended for technologies that address unmet clinical needs and show clear evidence of patient benefit, initially focusing on diagnostic devices that support the NHS's urgent needs and financial sustainability [3][5]. It allows manufacturers to supply and use innovative medical devices within the NHS before obtaining full regulatory clearance, helping to bring new technologies to patients faster while maintaining patient safety through ongoing evidence collection in real-world settings [1][3][5].
This service contributes to the UK Government's Life Sciences Sector Plan and 10-Year Health Plan by enabling earlier patient access to safe and effective MedTech, supporting the NHS's financial sustainability, reinforcing the UK's ambition to be a global leader in medical device innovation, and facilitating regulatory innovation and reform [1][3].
The MHRA is aiming to become a global leader in risk-proportionate regulation of MedTech, and the Early Access service is a step towards achieving this goal. CE marked devices will continue to be indefinitely recognized in the UK [7].
The Early Access service is shaped by stakeholder engagement with key sector representatives and learnings from the Unmet Clinical Need Authorisation (UCNA) tool [2]. A stakeholder survey for the Medicines and Medical Devices Act 2021 has been launched by the MHRA to gather feedback and insights [6].
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 author's comments or questions about the AI used can be directed to [email protected].
References:
- MHRA. (2023). Early Access service for innovative diagnostic devices. Retrieved from https://www.mhra.gov.uk/early-access-service
- MHRA. (2021). Unmet Clinical Need Authorisation (UCNA) tool. Retrieved from https://www.mhra.gov.uk/ucna
- UK Government. (2021). Life Sciences Sector Deal. Retrieved from https://www.gov.uk/government/publications/life-sciences-sector-deal
- UK Government. (2021). Life Sciences Vision. Retrieved from https://www.gov.uk/government/publications/life-sciences-vision
- UK Government. (2019). 10-Year Health Plan. Retrieved from https://www.gov.uk/government/publications/nhs-long-term-plan
- MHRA. (2023). Stakeholder survey for the Medicines and Medical Devices Act 2021. Retrieved from https://www.mhra.gov.uk/stakeholder-survey
- MHRA. (2021). Medical devices and IVDs: Brexit transition. Retrieved from https://www.mhra.gov.uk/brexit-transition
- MHRA. (2023). Post-market surveillance. Retrieved from https://www.mhra.gov.uk/post-market-surveillance
- The Early Access service for innovative diagnostic devices, part of the MHRA's regulatory reform, aims to accelerate the availability of medical devices addressing unmet clinical needs, thereby contributing to the health-and-wellness sector by facilitating quicker access to safe and effective therapies-and-treatments.
- The UK Government's Life Sciences Sector Plan and 10-Year Health Plan support the Early Access service, as it enables patients to access new medical technology sooner, thus enhancing the UK's ambition to be a global leader in medical device innovation and supporting business growth in health-and-wellness technologies.
- This service encourages collaboration between manufacturers, clinicians, and NHS leaders to support the NHS's financial sustainability and improve science and technology in health-and-wellness, including diagnostic devices, devices for medical-conditions, and other medical devices.
- In line with the MHRA's goal to be a global leader in risk-proportionate regulation of medical devices, finance remains a crucial element in the Early Access service to facilitate the commercialization of technologies that bring innovation to medical-conditions management while maintaining patient safety during real-world settings.
