EU-Wide Advantages & Opportunities for “Facilitating the conduct of multinational clinical studies of orphan devices and/or highly innovative (‘breakthrough’) devices” (HORIZON-HLTH-2025-03-IND-03-two-stage)

1. Single Market Access – 450 + Million Potential End-Users

• Unified CE‐Mark Route: The grant explicitly funds generation of clinical data for CE-marking under MDR/IVDR. Once obtained, one conformity assessment unlocks all 30 + EEA/EEA-equivalent markets—dramatically larger than any single national market.

• Early Hospital Uptake: Multinational clinical trials accelerate early-access/compassionate-use programmes in multiple Member States, creating ‘beach-head’ reference centres and KOL champions across Europe.

• Payer Evidence Packages: Harmonised clinical-economic evidence supports EU-scale negotiations with national HTA bodies and procurement alliances (e.g. EHPPA, AHO, G-Cloud for digital devices).

2. Cross-Border Collaboration & Knowledge Exchange

• Critical Mass of Rare Patients: Pooling patients from at least two countries solves the fundamental recruitment bottleneck for orphan devices; linkage to European Reference Networks (ERNs) further expands access to ultra-rare cohorts.

• Pan-European Clinical Expertise: Multidisciplinary consortia integrate surgeons, interventional radiologists, AI scientists, ethicists and SSH experts, fostering gold-standard protocols transferable EU-wide.

• Shared Infrastructure: Use of EU platforms (EUDAMED, BBMRI-ERIC biobanks, ELIXIR data nodes) reduces duplication and ensures FAIR data stewardship.

3. Alignment with Key EU Strategies

• EU Pharmaceutical & Medical Devices Legislative Package: Supports MDR/IVDR implementation by delivering robust clinical evidence and post-market surveillance models.

• Europe’s Beating Cancer Plan & Rare Disease Policy: Orphan oncology and paediatric devices directly address these flagship initiatives.

• Digital Europe & AI Act Readiness: Projects involving AI-driven diagnostics can pilot compliance with upcoming AI risk-management requirements, giving first-mover advantage.

• Green Deal Synergy: Device redesign for re-usability or lower material footprint can link to circular-economy targets, unlocking additional EIC/InvestEU green funding.

4. Regulatory Harmonisation Benefits

• Single GCP / ISO-14155 Framework: Uniform clinical investigation standards lower transaction costs vs. navigating 27 divergent national frameworks.

• EMA & Expert Panels Access: Horizon funding enables early scientific advice sessions (costly for SMEs otherwise), de-risking regulatory pathways.

• Template-Driven Submission: Mandatory clinical-study annex aligns with EU-level templates, streamlining competent-authority approvals.

5. Embedded in Europe’s Innovation Ecosystem

• Research Powerhouse: 5 of the world’s top 10 medical-technology universities are in the EU. Horizon consortia provide direct lab-to-market pipelines.

• Living Labs & DIHs: Digital Innovation Hubs, EIT Health accelerators and Test Beds offer real-world validation environments.

• Talent Magnet: Marie-Skłodowska-Curie and Erasmus+ networks feed highly skilled clinicians, engineers and data scientists into project pipelines.

6. Funding Synergies & Leverage

• Cascade Funding: Results feed naturally into EIC Transition or Accelerator calls for scale-up capital (up to € 17.5 m per SME).

• EU4Health & ERDERA: Complementary grants can fund additional registry work or patient-engagement activities beyond the core RIA.

• Structural Funds (ERDF) & Recovery Plans: Regional authorities can co-finance trial sites’ infrastructure upgrades, boosting TRL progression.

• InvestEU MedTech Window: Positive trial data becomes bankable collateral for blended finance instruments.

7. Scale, Impact & Market Leadership

• First-Mover Advantage in Breakthrough Devices: Rapid EU-wide deployment can set the de-facto clinical standard before U.S./Asian competitors enter.

• Economic Multipliers: Each €1 of Horizon medical-device R&D is estimated to generate €5 in private follow-on investment; pan-EU positioning amplifies this effect.

• Health Equity: Multinational study designs embed gender, age, ethnicity and socio-economic variables, making resulting devices broadly generalisable across Europe’s diverse populations.

8. Strategic Value Unique to EU Level

1. Volume Without Duplication: Only the EU can combine scarce rare-disease patients at scale while maintaining one regulatory and ethical framework.

2. Policy Influence: Consortium findings can feed directly into ongoing MDR/IVDR delegated acts and AI Act standards, shaping future market rules to their advantage.

3. Cost Efficiency: Lump-sum MGA reduces administrative burden; currency risk is neutralised inside the Eurozone.

4. Geopolitical Resilience: EU strategic autonomy in health tech is strengthened, aligning with the European Health Union vision.

9. Actionable Next Steps for Applicants

• Map ERN nodes relevant to target indication to secure patient pipelines.

• Engage early with EMA’s high-risk device pilot; budget advisory fees into work package 1.

• Plan a joint CE-mark & HTA evidence dossier using EUnetHTA-21 methodological guidelines.

• Explore parallel application to EIC Transition for device miniaturisation or AI algorithm refinement.

• Negotiate letters of support from national Ministries of Health to streamline multi-country ethical approvals.

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In summary, operating at an EU scale through this Horizon RIA offers orphan and breakthrough device developers unparalleled access to patients, regulators, financiers and markets that no single Member State can match. The grant de-risks clinical validation, accelerates CE-marking and paves the way for rapid, equitable deployment of life-saving technologies across Europe.