The Project


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 patients can get access to technologies benefiting mainly conditions that have limited or no alternative therapeutic options, medical device innovators gain earlier insights into product development, leading to a more flawless development process. The overall healthcare system benefits by driving innovation excellence and raising attractiveness for pursuing innovations in EU.

Attract investment into innovation in Europe

Improve patient access with unmet medical needs

Enhance the evidence generation cycle

Foster clinical excellence


22 public and private consortium partners are working together for a period of 4 years to collect and systematize information regarding the regulatory framework and the current status of pre-market evidence generation programs, develop, test and validate through pilot uses cases a robust and widely acceptable methodology, and make EU a conducive environment to undertake EFS.

Key Values

EU Collaboration

Healthcare innovation

Clinical and scientific

Patient access

Focus Areas

Among the main steps of the project are:


Conduct research and analysis on state of play of regulatory framework and characteristics and impacts of pre-market programs.


Build a sustainable network of stakeholders to promote the implementation of EFS in the EU.


Develop a sound, widely applicable and harmonised EU methodology and recommendations to uptake EFS.


Undertake pilot use cases to test the proposed methodological framework.


Develop instruments to monitor the performance of the EU EFS program.


Implement a dedicated, sustainable, open access informative online portal dedicated to EFS and disseminate the project results and recommendations.