Mission
The goal of the HEU-EFS project is to establish an EU methodology for Early Feasibility Studies (EFS) in the EU. This will support the evidence generation pathway for medical device innovators.
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.
Attract investment into innovation in Europe
Improve patient access with unmet medical needs
Enhance the evidence generation cycle
Foster clinical excellence
Twenty-two public and private consortium partners are collaborating over a four-year period to collect and systematize information on the regulatory framework and the current status of pre-market evidence generation programs. They aim to develop, test, and validate a robust and widely acceptable methodology through pilot use cases, ultimately making the EU a conducive environment for undertaking EFS.
EU Collaboration
Healthcare innovation
Clinical and scientific
excellence
Patient access
Among the main steps of the project are:
1
Conduct research and analysis on state of play of regulatory framework and characteristics and impacts of pre-market programs.
2
Build a sustainable network of stakeholders to promote the implementation of EFS in the EU.
3
Develop a sound, widely applicable and harmonised EU methodology and recommendations to uptake EFS.
4
Undertake pilot use cases to test the proposed methodological framework.
5
Develop instruments to monitor the performance of the EU EFS program.
6
Implement a dedicated, sustainable, open access informative online portal dedicated to EFS and disseminate the project results and recommendations.