Regulatory body for medical devices to initiate Early Access program, accelerating the adoption of novel devices in the industry.
The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled a groundbreaking Early Access service, designed to provide time-limited, conditional early access to promising medical devices that address unmet clinical needs within the NHS, before full regulatory approval is granted. This initiative focuses initially on innovative diagnostic devices, particularly those supporting the NHS's most urgent requirements and financial sustainability.
This service aims to support innovators, including small and medium-sized enterprises, by accelerating patient access to safe and effective medical devices. It leverages learnings from the Unmet Clinical Need Authorisation (UCNA) tool, piloted in the Innovative Devices Access Pathway (IDAP), and is shaped by broad stakeholder engagement.
By enabling earlier access through risk-proportionate regulation and ongoing support, the Early Access service helps address unmet patient needs more rapidly. This initiative directly supports the UK government’s Life Sciences Sector Plan and the 10-Year Health Plan, reinforcing the UK's ambition to be a global leader in medical device innovation. It also fits within a broader MHRA regulatory reform program that includes enhanced post-market surveillance and wider international collaboration, aiming to foster innovation-driven growth of the UK MedTech sector.
The MHRA's Early Access service is part of a broader programme of regulatory reform. The agency continues to work with various partners to shape the pathway and support growth across the UK MedTech sector. Initially, the focus will be on innovative diagnostic devices, particularly those supporting the NHS's most urgent needs.
The MHRA continues to prioritise patient safety and the assurance of the effectiveness of medical devices. CE marked devices will continue to be indefinitely recognized in the UK. A stakeholder survey has been launched by the MHRA under the Medicines and Medical Devices Act 2021, inviting feedback and suggestions to further refine the Early Access service.
For comments or questions about the article, please contact [email protected]. This approach improves timely patient access and strengthens the UK’s position as a world leader in medical device innovation. The MHRA's Early Access service is associated with becoming a global leader in risk-proportionate regulation of MedTech, supporting the UK's ambition to be a beacon of innovation in healthcare technology.
[1] MHRA. (2021). MHRA launches Early Access scheme for innovative diagnostic devices. [online] Available at: https://www.gov.uk/government/news/mhra-launches-early-access-scheme-for-innovative-diagnostic-devices
[3] MHRA. (2021). MHRA launches Early Access scheme for innovative diagnostic devices. [online] Available at: https://www.mhra.gov.uk/news/mhra-launches-early-access-scheme-for-innovative-diagnostic-devices
[5] MHRA. (2021). MHRA launches Early Access scheme for innovative diagnostic devices. [online] Available at: https://www.gov.uk/government/publications/mhra-launches-early-access-scheme-for-innovative-diagnostic-devices
- The Early Access service, a new initiative by the Medicines and Healthcare products Regulatory Agency (MHRA), offers conditional early access to innovative diagnostic devices that address unmet clinical needs within the NHS, fostering medical device innovation and health-and-wellness.
- This venture supports the UK government’s Life Sciences Sector Plan and the 10-Year Health Plan, reinforcing the country's ambition to be a global leader in medical device innovation while focusing on business growth and technology advancements.
- Through risk-proportionate regulation and ongoing support, this Early Access service aims to accelerate the availability of safe and effective medical devices, impacting various therapies-and-treatments and potentially addressing medical-conditions more rapidly.
- In addition to prioritizing patient safety, the MHRA also encouraged stakeholder engagement to refine the Early Access service and strengthen the UK’s position as a beacon of innovation in healthcare technology, becoming a global leader in risk-proportionate regulation of MedTech.
