To support interested applicants, a variety of resources are already available, including training videos, templates, and essential documents. These materials are designed to help you better understand and navigate the pilot process. You can access them directly through the links provided below.
Access Training videos here.
CIP and Checklist, Informed Consent template and Contract and liability documents available here.
June 2026
The HEU-EFS call for expressions of interest for pilots to test the HEU-EFS dedicated framework to promote the uptake of Early Feasibility Studies (EFS) in Europe has highlighted strong interest demonstrating a clear need for such frameworks.
By inviting external innovators to test the project’s methodology in real-world settings, the call has helped translate a policy ambition into a practical validation exercise. The results are encouraging: eleven expressions of interest were in total received.
The interest in the call shows the importance of Early Feasibility Studies, as Europe still lacks a harmonised route for conducting these studies, even though such studies are essential in the early stages of clinical evidence generation plans for certain medical devices. HEU-EFS launched the initiative to widen participation beyond the consortium, gather independent feedback, and build a strong and diverse portfolio of pilots capable of testing the framework under real-world conditions.
The process was carefully structured. Following earlier pilot sourcing within the consortium, the public call for expressions of interest was promoted through the HEU-EFS website and social media, with the application period closing on 31 March 2026.
Applicants completed an online expression of interest, discussed their proposals with the HEU-EFS Screening Committee, and received guidelines, templates, work instructions and training materials to support the next steps.
For innovators, the pilot offers a unique opportunity to take their technologies through a structured EFS process, benefit from early engagement with National Competent Authorities, learn directly from consortium experts, and provide feedback to the Consortium that will help to shape the future EU EFS programme.
The call invited sponsors planning to conduct EFS clinical investigations in Europe.
To be eligible, proposals had to be consistent with the ISO 14155:2020 definition of an Early Feasibility Study, concern high-risk Class III or Class IIb devices requiring a clinical investigation for conformity assessment, and meet at least one innovation criterion: addressing an unmet need as a breakthrough device, improving anatomical understanding, or exploring a new or expanded intended use. Sponsors also needed to plan submission for approval in at least one EU or European Economic Area country.
The early results suggest the call is delivering value. The expression-of-interest form was completed fourteen times. Of those submissions , eleven came from Open Call respondents and three from private consortium partners. Following the screening process, the Steering Committee is reviewing carefully eligibility and supporting the applicants throughout the process.
Beyond recruitment, the process is already generating practical lessons that will help refine the methodology, templates and KPIs, and inform the design of a future EU EFS framework.
The call for expressions closed on 31st March 2026. If there is an interest in submitting a pilot, please contact pilot@heuefs.eu