Statement of Policy Intent: Early Access to Innovative Medical Devices
The MHRA's initial plans on an Early Access service, which will be developed further throughout 2025.
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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.