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.
ISO 14155:2020 defines Early Feasibility Studies (EFS) as limited clinical investigations designed to evaluate the initial clinical safety and performance of a medical device.
Conducted at an early stage, before the device design is finalised, EFS help collect critical insights on a device’s design, safety, functionality, and performance, especially when further nonclinical testing is unavailable or not informative.
Why EFS Matter
EFS play a key role in the evidence generation pathway, offering the potential to:
The Current Challenge
While EFS are permitted under the EU Medical Device Regulation (MDR), there is currently no harmonised pathway or specific framework to support their systematic adoption across the European Union (EU).
The HEU-EFS initiative aims to change this by developing a unified, structured approach to Early Feasibility Studies, enabling innovation and collaboration across Europe.