The Project

Mission

The goal of the HEU-EFS project is to establish an EU methodology for Early Feasibility Studies in the EU. This will support the evidence generation pathway for medical device innovators.

Early Feasibility Studies (EFS) constitute a crucial phase in the journey towards medical device approval. An EFS is a clinical study conducted on a medical device in its nascent developmental stages. Typically involving a small number of participants, an EFS primarily assesses the initial clinical safety and performance of the device, providing guidance for product modifications. EFS plays a pivotal role in enabling medical device developers to focus their efforts on products with genuine potential to allow access for patients with unmet needs or suffering from life-threatening or highly debilitating disease.

Thanks to the HEU-EFS methodology, medical device innovators gain earlier insights into product development, leading to a smoother development process. The overall healthcare system benefits by driving innovation excellence and increasing the attractiveness of pursuing innovations in the EU. Ultimately, patients with limited or no alternative healthcare solutions benefit from access to innovative medical technologies.