Facilitating the conduct of multinational clinical studies of orphan devices and/or of highly innovative (“breakthrough”) devices

Proposals under topic HORIZON-HLTH-2025-03-IND-03-two-stage should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:

• Healthcare providers increase their hands-on experience regarding the clinical use of orphan devices and/or of highly innovative (“breakthrough”) devices and get timely access to such devices with demonstrated clinical benefits;
• Developers and manufacturers collect and obtain scientific evidence on their proposed intervention/ approach with the device under investigation;
• Patients benefit from the development, studies and use of orphan devices and/or of highly innovative (“breakthrough”) devices;
• Companies in the EU and associated countries get a better market position in this field and improve their knowledge on how to conduct multinational clinical studies for these devices.

Interested parties can find more information and apply on the Funding and Tenders Portal.