This funding call, part of Horizon Europe Cluster 1 - Health, aims to support multinational clinical studies for orphan devices and/or highly innovative ('breakthrough') devices. These devices, which address rare diseases or unmet medical needs, often face challenges in clinical data generation due to limited patient recruitment and high costs. The call focuses on generating evidence for CE marking under medical device regulations and ensuring timely access to these devices for healthcare providers and patients.

The scope includes designing and conducting studies in at least two EU or Associated Countries, developing patient recruitment strategies, and engaging social sciences and humanities experts to enhance societal impact. Expected outcomes include improved healthcare provider experience, timely access for patients, scientific evidence for manufacturers, and a strengthened market position for EU companies.

Opening: 22-05-2025
Deadline(s): 18-09-2025

Data provided by Kooperationsstelle Wissenschaft

This funding opportunity represents a pre-agreed draft that has not yet been officially approved by the European Commission. The final, approved version is expected to be published in the first quarter of 2025. This draft is provided for informational purposes and may be used to preliminarily form consortia and develop project ideas, but it is offered without any guarantees or warranties.