Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices
Quick Facts
Ready to Apply?
Get a personalized assessment of your eligibility and application strategy
See in 5 min if you're eligible for Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices offering max €80.0M funding💰 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.*
📊 At a Glance
🇪🇺 Strategic Advantages
EU-wide Advantages and Opportunities for HORIZON-HLTH-2025-01-IND-02
1. Single Market Access
• A harmonised, digital conformity-assessment pathway simplifies pan-EU certification, enabling simultaneous market entry in 30+ EU/EEA/associated countries and immediate reach to over 450 million citizens and 6 000+ hospitals.
• Reduced duplication of technical documentation lowers typical multi-country launch costs by 20-30 %, accelerating revenue generation for SMEs.
2. Cross-Border Collaboration & Knowledge Exchange
• Mandatory inclusion of diverse Notified Bodies (public/private, large/small) and manufacturers creates a living ‘sandbox’ where best practices from 15-20 Member States converge into shared workflows.
• Opens fast lanes for joint ventures between software vendors, med-tech start-ups, university hospitals and NB IT teams, shortening development cycles of AI-driven regulatory tools by an estimated 12-18 months.
• Facilitates staff secondments funded under the CSA to build EU-wide digital-regulatory skill sets that are scarce at national level.
3. Alignment with Flagship EU Policies
• Digital Europe Programme: proposed cloud-based platform can plug into European Health Data Space and European Blockchain Services Infrastructure for secure evidence exchange.
• Green Deal/CEAP: paper-less, data-driven submissions cut courier transports and printing, potentially saving 1 000 t CO₂/year when fully scaled.
• SME Strategy & Industrial Policy: lowers entry barriers for 33 000+ EU med-tech SMEs, safeguarding strategic autonomy in critical health technologies.
4. Regulatory Harmonisation Benefits
• Moves conformity assessment from document to data paradigm, supporting MDR/IVDR implementation and reducing heterogeneity of NB checklists.
• Early integration of expert panels & EU reference laboratories prevents divergent scientific opinions, cutting average review loops from 3 to 1.
• Creates a de-facto EU standard interface that can later be incorporated into future delegated acts or MDCG guidance without reopening legislation.
5. Strengthening the EU Innovation Ecosystem
• Links to Europe’s 500+ Digital Innovation Hubs, EIT Health nodes and standardisation bodies (CEN/CENELEC) give projects immediate testing grounds.
• Access to pan-European clinical networks (e.g., EUnetHTA HTA collaboration) allows real-world verification of digital KPIs.
• Facilitates uptake of open-source components developed under other Horizon projects (e.g., OpenDei, MedTech4Europe) – reducing coding costs by up to 40 %.
6. Funding Synergies
• LIFE and Interreg programmes can co-finance eco-design and cross-border pilot sites.
• Digital Europe DEP-DIGITAL-2025-CLOUD could finance scaling of the platform’s high-performance computing back-end.
• InvestEU and EIB thematic windows can later provide growth capital for spin-offs commercialising the digital assessment tool.
7. EU-Scale Deployment & Impact Potential
• A successful pilot covering 3–4 NBs can be rolled out to all 43 MDR/IVDR-designated NBs within 3 years, yielding an estimated 35 % reduction in certification lead-time EU-wide.
• Predictability gains could unlock €3–5 billion in additional R&D investment by European SMEs over a decade.
• Strengthens Europe’s global competitive edge vs. US FDA’s eSTAR system, positioning the EU as first choice for innovative device launch.
8. Practical Recommendations for Applicants
1. Build a consortium of at least 10 countries, ensuring representation from northern, southern, eastern and cohesion Member States to maximise political buy-in.
2. Align IT architecture with EU Open Source Software Strategy and Gaia-X principles to future-proof data sovereignty.
3. Reserve budget for a ‘Joint Stakeholder Forum’ that meets bi-annually with MDCG subgroups to secure rapid consensus.
4. Map interoperability with EUDAMED modules (UDI/devices, certificates, vigilance) to demonstrate complementarity, not overlap.
5. Plan an exploitation work-package that sketches post-grant sustainability via a European non-profit association or public-private partnership.
> Operating at EU level transforms digital conformity assessment from a patchwork of bilateral exchanges into a single, trusted, data-driven backbone for the entire medical-device value chain, multiplying economic, regulatory and societal returns well beyond what any national initiative could achieve.
🏷️ Keywords
Ready to Apply?
Get a personalized assessment of your eligibility and application strategy
See in 5 min if you're eligible for Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices offering max €80.0M funding