# Statement of Policy Intent: Early Access to Innovative Medical Devices

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/5ef87a84-b5c8-43a9-96b0-af5ea8fa8a1e
Type: Standard
Published: July 30, 2025

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) is advancing its strategy to streamline patient access to innovative medical technologies. This initiative aligns with the UK Government's 10-year Health Plan and the Life Sciences Sector Plan, positioning the UK as a global leader in medical innovation. The core development involves transforming the Unmet Clinical Need Authorisation (UCNA) tool, which was previously part of the Innovative Devices Access Pathway (IDAP) pilot, into a permanent, routine Early Access service. This service is designed to support innovators operating outside structured pathways like IDAP, specifically targeting medical technologies that address significant unmet clinical needs. Under this regulatory framework, the MHRA aims to employ risk-proportionate regulation while providing continuous support to developers. The primary objective is to accelerate the delivery of safe, cutting-edge devices to patients who currently lack effective treatment options. By institutionalizing the UCNA tool, the MHRA seeks to provide a predictable and efficient route for innovative products to enter the UK market, fostering a dynamic environment for clinical advancement.

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## Content

The UK medical devices market is dynamic and innovation-driven. To ensure quick and safe patient access to innovative technologies, the MHRA is taking key actions aligned with the Government’s 10-year Health Plan and Life Sciences Sector Plan. The MHRA is developing a service to facilitate earlier access to innovative technologies in areas of unmet clinical need based on learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP). The intent is to turn the UCNA tool into a routine 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.

## Attachments

- [Statement of Policy Intent: Early Access to Innovative Medical Devices](/government/publications/statement-of-policy-intent-early-access-to-innovative-medical-devices/statement-of-policy-intent-early-access-to-innovative-medical-devices)