💰 Funding Details

Funding Description

1. What the Grant Supports

* Coordination and Support Action (CSA) to design, test and roadmap the digitalisation of the entire MDR/IVDR conformity-assessment pathway (from pre-application to certificate issuance).

* Activities must include:

* Feasibility study (mapping, requirements, stakeholder consultation, technical specs).

* Pilot-scale digital platform (or adaptation of an existing one) covering all key actors (manufacturers, Notified Bodies, EU reference labs, expert panels, regulators).

* Consensus-building, governance recommendations and a scale-up roadmap.

* Definition and monitoring of Key Performance Indicators (KPIs).

* Research & Innovation activities, standardisation work, training, workshops, dissemination and exploitation planning are eligible.

2. Budget & Funding Model

* Maximum EU contribution per project: €80 million (lump-sum grant).

*The Commission expects to fund 1 large, high-impact CSA in the €10–25 million range, but larger budgets are admissible if duly justified.*

* Funding rate: 100 % of eligible lump-sum costs (no co-funding required).

* Lump-sum payments are tied to predefined work-package-level milestones/deliverables agreed during grant preparation; no cost reporting.

3. Who Can Apply

* Consortium required (single legal entity not sufficient for CSA).

Minimum: 3 independent legal entities established in 3 different EU Member States or Associated Countries, but a broad, multidisciplinary consortium is strongly recommended.

* Eligible participants: universities, research organisations, notified bodies, industry (incl. SMEs and start-ups), standardisation bodies, patient associations, IT providers, consultancies, national competent authorities.

US entities may participate and be funded. Chinese entities may participate without funding.

* Applicants must have proven expertise in:

• MDR/IVDR conformity assessments

• Health IT architecture, cybersecurity & interoperability (FHIR, SNOMED-CT, EUDAMED links)

• Data protection (GDPR compliance)

• Stakeholder engagement & consensus methodologies.

4. Geographic & Policy Conditions

* All beneficiaries must be established in the EU or Horizon Europe Associated Countries, except as stated above.

* Projects must operate within the existing regulatory framework (no legal amendments) and respect EU data-protection, cybersecurity and medical-device legislation.

5. Timing & Key Milestones

* Call opens: 22 May 2025

* Submission deadline (single stage): 16 September 2025, 17:00 CET

* Indicative evaluation results: December 2025

* Grant agreement signature: March 2026

* Expected project duration: 36–48 months.

6. Evaluation Criteria & Thresholds

* Excellence (0–5) – ≥4

* Impact (0–5) – ≥4

* Quality & efficiency of implementation (0–5) – ≥4

* Overall threshold: ≥12/15

7. Compliance Checklist

* Cover all MDR/IVDR conformity-assessment steps.

* Ensure representation of small & large, public & private Notified Bodies.

* Demonstrate clear link to Destination 1: Maintaining an innovative, sustainable & competitive EU health industry.

* Provide a feasible governance & sustainability plan for post-project exploitation (even though infrastructure governance itself is out of scope).

*Remember: no clinical trials, product development or regulatory lobbying costs are eligible under this CSA.*

📊 Evaluation Criteria

Evaluation Criteria & Tips (Thresholds: 4/4/4 — Cumulative 12)

1. Excellence

* Clarity of digitalisation concept, novelty beyond existing NB workflows.

* Robust methodology for feasibility study, pilot design and KPI selection.

2. Impact

* Credible pathway to EU-wide roll-out, quantified time- and cost-savings for SMEs.

* Alignment with destination impacts and EU Digital Single Market.

* Detailed plan for exploitation by MDCG, NBs and industry.

3. Implementation

* Realistic work plan covering feasibility, pilot and roadmap within 3–4 years.

* Lump-sum budgeting that links milestones to deliverables (e.g., pilot go-live).

* Governance ensuring consensus-building (steering group, stakeholder forum).

📝 Application Strategy

Application Strategy

1. Build a Mission-Driven Consortium

1. Core leadership: a top-tier regulatory science institute or notified body with MDR/IVDR expertise as coordinator.

2. Digital tech partners: health-IT vendors, cloud providers, cybersecurity experts, semantic-interoperability specialists.

3. Stakeholder board: at least 5 notified bodies (mix of sizes & business models), 5–10 device/IVD manufacturers (≥50 % SMEs), EU reference labs, expert panel representatives, competent authorities.

4. Societal actors: patient group(s), standardisation bodies (CEN/CENELEC), professional societies.

2. Craft a Competitive Narrative (Proposal Part B)

2.1 Excellence

* Problem statement: current PDF‐based exchanges create cost, error and delays → quote published MDCG reports and SME surveys.

* Objectives (SMART): e.g. reduce NB review-cycle time by 30 %, cut documentation errors by 50 %, achieve ≥80 % stakeholder satisfaction.

* Methodology:

• Use BPMN to model workflows;

• Apply agile software development;

• Align data model with EUDAMED, FHIR, UDI & ISO/IEC 82304.

* Innovation: first EU-wide, data-driven conformity-assessment platform; AI-assisted completeness checks; API-based single entry point.

2.2 Impact

* Pathway to impacts table linking outputs → outcomes → destination impacts.

* KPIs & baselines aligned with MDCG performance metrics.

* SME benefits quantified (cost-savings, time-to-market reduction).

* Scalability plan: integration with EUDAMED & national vigilance systems.

* Policy contribution: feed results into MDCG guidance & future Digital Product Passport initiatives.

2.3 Implementation

* GANTT & PERT: 36-month schedule, clear critical path.

* Work Packages:

1. Project management & ethics

2. Feasibility study (M1-M9)

3. Platform specification & architecture

4. Pilot implementation & validation

5. Consensus & standardisation actions

6. Roadmap & business model

7. Communication, dissemination & exploitation.

* Risk management: include regulatory misalignment, data-privacy breaches, stakeholder disengagement; provide mitigation.

* Lump-sum budgeting: allocate costs by WP; justify tranche values with tangible deliverables (e.g. pilot Go-Live, KPI report, roadmap).

3. Prepare for Evaluation Success

* Use the Horizon lump-sum template: provide cost-calculation annex explaining person-months, travel, subcontracting.

* Include letters of commitment from all NBs and competent authorities to prove consensus-building credibility.

* Articulate European added value: cross-border harmonisation, alignment with Digital Single Market, potential for global leadership.

* Embed open-science practices: FAIR data, open-source components where feasible, public KPI dashboard.

4. Timeline & Action Plan (Backward Planning)

* April 2025 – Consortium finalised; assign proposal sections.

* May–July 2025 – Co-design workshops with NBs & SMEs; draft excellence & impact sections.

* 15 August 2025 – Internal full-proposal freeze; launch quality review.

* 1 September 2025 – Upload first version to F&T portal; run validation checks.

* 16 September 2025 – Final submission.

5. Common Pitfalls to Avoid

* Ignoring NB diversity – ensure representation across device classes and scopes.

* Underestimating change-management costs – dedicate WP budget to training & onboarding.

* Vague lump-sum milestones – EU reviewers penalise unclear payment triggers.

* Scope creep into regulatory change – keep focus on *process digitalisation*, not legal amendments.

6. Post-Grant Leverage

* Use pilot results to seek CEF Digital or EU4Health funding for full infrastructure rollout.

* Engage with EUDAMED Joint Implementation Plan working groups for alignment.

* Position consortium as a European reference hub for regulatory-tech (RegTech) in healthcare.

Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices

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💰 Funding Details

Funding Description

1. What the Grant Supports

2. Budget & Funding Model

3. Who Can Apply

4. Geographic & Policy Conditions

5. Timing & Key Milestones

6. Evaluation Criteria & Thresholds

7. Compliance Checklist

📊 Evaluation Criteria

Evaluation Criteria & Tips (Thresholds: 4/4/4 — Cumulative 12)

📝 Application Strategy

Application Strategy

1. Build a Mission-Driven Consortium

2. Craft a Competitive Narrative (Proposal Part B)

2.1 Excellence

2.2 Impact

2.3 Implementation

3. Prepare for Evaluation Success

4. Timeline & Action Plan (Backward Planning)

5. Common Pitfalls to Avoid

6. Post-Grant Leverage

💡 Success Factors

❌ Common Mistakes to Avoid

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🏷️ Keywords

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