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

Due Dates: September 16, 2025 (Stage 1) | April 16, 2026 (Stage 2)

Funding Amounts: €6–8 million per project (lump sum); total call budget €40 million; ~5 grants expected; project duration typically 3–5 years

Summary: Supports multinational clinical studies for orphan and highly innovative ("breakthrough") medical devices, including digital and AI-based tools, to advance clinical evidence and innovation in the EU health sector.

Key Information: Requires collaboration across at least two EU or Associated Countries; SMEs encouraged to participate; two-stage application process.

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

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