💰 Funding Details

Funding at a Glance

Call Identifier: HORIZON-HLTH-2025-03-IND-03-two-stage

Action Type: HORIZON-RIA (Research & Innovation Action) – Lump Sum

Max. EU Contribution per Grant: €50 000 000

Evaluation Model: Two-stage (blind stage-1)

Destination: *Maintaining an innovative, sustainable, and competitive EU health industry*

What is Financed?

* Multinational clinical studies (min. 2 EU/Associated Countries) on:

* Orphan medical devices (≤12 000 patients/year in EU) and/or

* Highly innovative “breakthrough” devices (major clinical benefit, incl. digital & AI-based technologies).

* Activities can be pre-market or post-market and may cover design, regulatory strategy, data generation, patients’ involvement, SSH integration, and dissemination of best practices.

Reimbursement Modality

* Lump-sum grant: the budget is agreed ex-ante at proposal stage; reporting focuses on *milestones & deliverables* rather than cost statements.

* Indirect costs are built into the lump sum (25 % flat rate).

Key Eligibility Highlights

* Consortia must include ≥ 3 entities from ≥ 3 eligible countries (at least one EU MS).

* Clinical study must be *multinational* (≥ 2 countries).

* SMEs, patient organisations, and SSH experts are strongly encouraged.

* The Joint Research Centre (JRC) may join the consortium.

* Entities from the USA are eligible for funding.

Calendar

| Milestone | Date (Brussels time) |

|-----------|---------------------|

| Call opens | 22 May 2025 |

| Stage 1 deadline (blind) | 16 Sep 2025 – 17:00 |

| Stage 1 results | ≈ Nov 2025 |

| Stage 2 deadline | 16 Apr 2026 – 17:00 |

| Grant signature | ≈ Oct 2026 |

| Project start | Q4 2026-Q1 2027 |

> Contact your National Contact Point (NCP) in your country for personalised eligibility checks.

📊 Evaluation Criteria

How Your Proposal Will Be Scored

|-----------|---------------|----------------|-----------|

| Excellence | ✓ | ✓ | 4/5 |

| Impact | ✓ | ✓ | 4/5 |

| Quality & Efficiency of Implementation | — | ✓ | 4/5 |

Overall cumulative threshold at Stage 2: ≥ 12/15.

What Evaluators Look For

Excellence

* Clarity of objectives addressing *orphan/breakthrough* definition.

* Soundness of clinical study design: endpoints, statistical power across ≥ 2 countries, gender/intersectional analysis.

* Integration of cutting-edge AI/digital components where relevant.

Impact

* Credible path to CE-mark conformity, market uptake, and improved patient outcomes.

* Spill-over to EU industry competitiveness; concrete KPIs (e.g., % time-to-market reduction).

* Dissemination & exploitation plan—including your country-level scaling.

Implementation (Stage 2 only)

* Coherent work plan with milestone-based lump-sum structure.

* Competence of consortium: track record in multinational trials, regulatory affairs, SSH.

* Risk management (patient recruitment, regulatory delays, data privacy) with mitigation actions.

📝 Application Strategy

Winning Strategy for Applicants

1. Build a Mission-Driven Consortium

* Combine clinical centres with proven rare-disease enrolment capacity in at least two your country/EU sites.

* Include device developer/SME, notified-body advisors, regulatory specialists, and SSH partners for gender-, ethics-, and socio-economic dimensions.

* Involve patient organisations from day 1 to co-design endpoints and recruitment campaigns.

2. Master the Two-Stage Process

1. Stage 1 (10-page blind outline)

* Focus on *Excellence* & *Impact* only.

* Remove all identifiers (organisation names, logos, URLs).

* Provide a sharp value proposition: unmet need, breakthrough nature, clinical benefit.

2. Stage 2 (full proposal)

* Add detailed implementation plan, lump-sum work package costing, and risk management.

* Attach the Clinical Study Annex template.

3. Align With Regulatory Pathways

* Map MDR/IVDR classification, conformity route, endpoints aligned with CE-mark requirements.

* Plan early dialogues with EMA, national CAs, HTA bodies;

schedule pre-submission meeting slots within the Gantt.

4. Embed SSH & Inclusiveness

* Provide a gender-sensitive, intersectional recruitment strategy (age, ethnicity, disability).

* Allocate WP for quality-of-life & patient-reported outcomes analysis led by SSH experts.

5. Exploit your country's Assets

* Leverage your country's strong hospital networks for rapid enrolment.

* Access your country research infrastructures (biobanks, AI compute) to accelerate data generation.

6. Optimise Lump-Sum Budgeting

* Define work packages as verifiable chunks (e.g., “First-in-human complete”, “Interim analysis delivered”).

* Price realistic yet competitive; reviewers dislike safety buffers > 5 % without justification.

7. Synergies & Visibility

* Reference complementarity with ERDERA and EU4Health results.

* Outline data-sharing via European Health Data Space and FAIR principles.

* Consider Copernicus/Galileo if geolocation or imaging data are involved.

💡 Success Factors

Early Engagement with Patient Registries

Connecting to **ERNs (European Reference Networks)** and national rare-disease registries in your country secures a recruitment pipeline and real-world data.

Integrated Data Governance Framework

Adopt **GDPR-by-design** e-CRF systems and reference the **European Health Data Space** to convince evaluators of smooth cross-border data flows.

Regulatory Scientific Advice Sessions

Budget at least **two formal meetings with EMA/national CAs**; attach tentative agendas and timelines.

Demonstrated SME Leadership

Projects where the **device-developer SME leads technical WPs** showcase commercial commitment and score higher on viability.

Robust Health-Economic Modelling

Include a **cost-utility analysis (e.g., QALY, ICER)** to quantify clinical benefit and attract HTA interest.

Alignment With ERDERA Roadmap

Cross-referencing ERDERA deliverables (e.g., common protocols) illustrates synergy and avoids duplication.

❌ Common Mistakes to Avoid

Under-powered Patient Recruitment Plans

Proposals often **overlook the difficulty of finding rare-disease patients across borders**. Reviewers will flag unrealistic accrual curves without letters of commitment from each site.

Ignoring Blind Evaluation Rules in Stage 1

Including hospital names, company logos, or hyperlinks that reveal identity **triggers automatic ineligibility** under the blind-evaluation pilot.

Weak Regulatory Evidence Strategy

Simply stating “data will support CE marking” is insufficient. You must **map the MDR/IVDR Annexes, classification, and planned interactions with notified bodies/EMA**.

Tokenistic SSH Integration

Listing an ethicist in the consortium without a **budgeted work package for gender & socio-economic analysis** is viewed as box-ticking and scores low on Impact.

Generic Dissemination Actions

Reviewers expect **device-specific pathways** (e.g., procurement dialogues with your country health insurers), not just conference presentations and journal papers.

Poor Lump-Sum Milestone Definition

Vague deliverables like “study ongoing” cannot be verified; the EC may reduce the lump sum at GA stage.

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

Quick Facts for Italy Applicants

Ready to Apply from Italy?