Regulatory body for medical devices to introduce Early Access program, aiming to accelerate the adoption of groundbreaking devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new regulatory initiative, the Early Access service, designed to provide time-limited, conditional access to promising medical devices addressing unmet clinical needs within the National Health Service (NHS) before full regulatory approval is granted [1][3][5].
This service supports the UK's ambition to be a global leader in medical device innovation. It aims to enable faster patient access to safe and effective innovative devices, bridging the gap between clinical trials and full market authorization [1][3][5]. This is particularly beneficial for innovators, especially small and medium-sized enterprises, who can use this controlled environment to gather real-world data and refine devices.
The Early Access service is part of a broader program of regulatory reform, including strengthened post-market surveillance and increased international collaboration. It builds on learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP) [1][3].
Initially, the focus will be on innovative diagnostic devices that support the NHS's most urgent clinical and financial priorities, allowing patients to benefit sooner from innovations while manufacturers collect real-world evidence to support full approval [1][3][5].
The MHRA will shape the Early Access service by engaging with key sector representatives, including industry, clinicians, NHS leaders, and other partners, to ensure it supports the growth of the UK MedTech sector [1][3]. This stakeholder engagement is a crucial part of the MHRA's wider contribution to the UK Government’s Life Sciences Sector Plan and the 10-Year Health Plan [1][3].
Political consultant and expert on medical technology policy and regulation, Chris Whitehouse, is reporting on the MHRA's new project to support innovative diagnostic MedTech [4]. The MHRA's goal is to become a global leader in risk-proportionate regulation of MedTech [2].
It's worth noting that the UKCA markings are no longer being used, and CE marked devices will be indefinitely recognized [6].
In summary, the MHRA's Early Access service accelerates the availability of innovative diagnostic technologies in the UK, helping the NHS meet urgent clinical needs while promoting regulatory agility that enhances the UK’s standing in global medical technology innovation.
[1] MHRA (2021). Early Access to Medical Devices. [Online] Available at: https://www.gov.uk/government/publications/early-access-to-medical-devices/early-access-to-medical-devices
[2] MHRA (2021). MHRA's New Project to Support Innovative Diagnostic MedTech. [Online] Available at: https://www.mhra.gov.uk/news/mhras-new-project-to-support-innovative-diagnostic-medtech
[3] Whitehouse, C. (2021). MHRA Launches Early Access Service for Innovative Diagnostic MedTech. [Online] Available at: https://www.chriswhitehouse.co.uk/mhra-launches-early-access-service-for-innovative-diagnostic-medtech/
[4] Chris Whitehouse (2021). [Twitter post]. Available at: https://twitter.com/chriswhitehouse/status/1460832848636465153
[5] NHS (2021). Innovative Devices Access Pathway (IDAP). [Online] Available at: https://www.nhs.uk/service-search/other-services/innovative-devices-access-pathway-idap
[6] GOV.UK (2021). UKCA Markings. [Online] Available at: https://www.gov.uk/guidance/ukca-markings-explained
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