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Statement of Policy Intent: Early Access to Innovative Medical Devices

Published 31 July 2025

Introduction

The UK medical devices market is a dynamic and innovation-driven sector. To ensure that innovative technologies reach patients quickly and safely, the MHRA is taking key actions aligned with the Government’s 10-year Health Plan for England and the Life Sciences Sector Plan. These strategies aim to drive health innovation, enable research and development, create an outstanding ecosystem for investment, and highlight the key importance of the MedTech sector in this.

Our ambition is to establish a regulatory regime that balances streamlined access through International Reliance with a refocused domestic UK Conformity Assessment (UKCA) route that enables innovation. We are transforming how the MHRA enables innovation through advice services, regulatory sandboxes, rapid approvals for clinical investigations, and the development of a service to facilitate earlier access to innovative technologies, as outlined in the Life Sciences Sector Plan.

This Statement of Policy Intent sets out our initial thinking on an Early Access service which will be developed further over the coming months. It takes on learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP) and is shaped by stakeholder engagement with key sector representatives. The intent is to turn the UCNA tool into a business-as-usual Early Access service available to innovators outside of an innovation pathway such as IDAP. This will enable more patients to benefit from earlier access to innovative technologies in areas of unmet clinical need. This will be delivered through risk-proportionate regulation and ongoing support for innovators, reinforcing the UK’s role as a global leader in innovative technology.

To support this work, the MHRA is investing in new internal capability to deliver the Early Access Service. This Statement is one example of our continued commitment of support for innovation and forms a key part of our broader strategy for medical device regulatory reform, including our recently implemented Post Market Surveillance regulations and announcements on International Reliance.

Opportunity

The UK’s medical device landscape consistently contributes to better patient outcomes supported by a strong foundation for healthcare innovation. In 2024 alone, the MHRA approved 84 clinical investigations for new medical devices. Building on this momentum, the MHRA is advancing efforts to speed up market access where there are challenges associated with generating sufficient evidence for immediate regulatory approval of medical devices addressing unmet clinical needs. We are delivering on Action 25 of the Life Science Sector Plan, to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval.

The IDAP pilot has demonstrated the value of coordinated regulatory support and a targeted access pathway for medical devices addressing unmet clinical needs, bringing transformative technologies to patients sooner. A key tool within IDAP was the UCNA tool. We plan to extend the use of the UCNA tool beyond innovative pathways such as IDAP, supporting broader innovation across the MedTech sector. To do so, we are investing in MHRA capability to establish an Early Access service as part of routine regulatory practice.

Further information on our future plans for innovation pathways will be made available soon.

The MHRA has identified three strategic opportunities to support this direction:

• Supporting access for patients: Transforming regulatory assessments into streamlined, risk-proportionate services, to reduce time to patient access for controlled populations.
• Widening innovator access to early access services: This approach especially supports early-stage and SME innovators by making a key service for early access more accessible, making Great Britain (GB) an attractive environment for innovators to start, grow, scale and invest.
• Evidence generation through real-world data: Enabling earlier market access, supported by real-world evidence generation to bridge the gap between research (i.e. clinical investigations) and scalable product development, where it may be challenging to navigate, while maintaining patient safety and robust standards.

Together, these opportunities position the UK to lead globally in medical device innovation. By enabling accelerated access to safe, effective medical devices, improving patient outcomes, and supporting the growth of the life sciences sector.

Vision

Our vision is to create a supportive, risk-proportionate regulatory environment, that enables safe, timely access to innovative medical technologies, particularly those that address unmet clinical needs in the NHS.

By doing so, we will help grow the UK Life Sciences sector, supporting companies to start, scale, and bring life-changing products to patients faster.

Success means supporting cutting-edge MedTech from early development through to safe, early access to market.

Early Access Service

The MHRA will launch an Early Access service to support the innovative MedTech sector. This service is designed to enable controlled and time-limited access to innovative medical devices that address unmet clinical needs and improve outcomes for Great Britain (GB) patients. It will help innovators to gather evidence on their devices in real world environments and by doing so bridge the gap between clinical investigation and full regulatory approval.

The Early Access service will be developed from the UCNA tool in IDAP, and has been informed by feedback from partners, pilot participants and wider engagement with the sector. In addition to its routine use, the Early Access service will be a key service within future innovation pathways.

It is separate from the existing Exceptional Use Authorisation (EUA) pathway which is not for innovation purposes. Further guidance on EUAs can be found here.

Purpose and Scope

The Early Access service will:

• Offer conditional market access for innovative devices that address clearly defined unmet clinical needs from the NHS or that have the potential to significantly improve patient outcomes.
• Offer a bridging scheme to maintain patient access to devices where the clinical investigation has ended and the manufacturer is still awaiting regulatory approval.
• Focus initially on innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs and financial sustainability in the NHS.

Conditional Authorisation Framework

Using the powers available in the Medical Devices Regulations 2002 (regulations 12, 26, and 39), the MHRA can exempt devices from meeting certain regulatory requirements. Where it is in the interests of patient or public health to do so, the MHRA can make an assessment of the risks and benefits of a device, the availability of any other devices or alternate medical options on the market to address the unmet clinical need, and, where appropriate, grant conditional access to patients for a time limited period.

Enhanced Regulatory Support

Innovators will receive structured regulatory support, such as:

• Regulatory advice: An advisory service will be established to offer participants advice and guidance on whether their device qualifies for this service, for a set fee.
• Planning: Setting clear milestones, documentation expectations, and benefit-risk criteria will be communicated early to innovators enabling better planning and regulatory engagement.

Innovative MedTech accessing the market through this service:

• Will receive time-limited authorisation, with specific conditions to ensure ongoing safety monitoring, and data collection.
• Will be expected to demonstrate continued progress toward full regulatory approval during this period.

Streamlined Market Adoption

To ensure that regulatory progress translates into real-world patient benefit, the MHRA will link the Early Access service with other government initiatives designed to improve MedTech adoption in the NHS.

Northern Ireland

To ensure dual access to both the UK Internal Market and EU Single Market, Northern Ireland (NI) applies the EU Medical Device Regulation and EU in vitro Diagnostic Medical Devices Regulation. During the development of this policy, the Government will carefully consider the interaction with arrangements that apply in NI and the impacts to the access for NI qualifying goods entering the GB market. The MHRA can exceptionally authorise devices for the NI market where there is a public health need.

Next Steps

The MHRA will work closely with key stakeholders across the life science ecosystem to refine the Early Access service for its implementation. We will also establish internal capability to deliver this service.

If you have general queries about this statement of policy intent, contact us at info@mhra.gov.uk.