EU-Wide Advantages and Opportunities for the “Inkjet-bioAM” Open Call

Overview

*Call identifier:

• inkjet-bioAM

*Grant agreement:

• 101161350

*Total budget:

• €540 000

*Project duration:

• 9 months

*Submission window:

• 16 June 2025 – 15 Sept 2025 (17:00 CET)

The call supports “Smart Manufacturing of Biomedical Applications by industrial Multi-material Inkjet Processes for improved Health Care.” The pan-European scope of the instrument unlocks a series of strategic advantages that cannot be matched at member-state level.

1. Single Market Access ― 450 M Consumers & Patients

- EU-wide adoption pathway: Successful prototypes can be commercialised simultaneously across 27 member states under the Medical Device Regulation (MDR) once CE-marked, avoiding 27 separate national approvals.

- Economies of scale: Centralised production runs for bio-inks and printed components become financially viable when serving a continental customer base.

- Public-procurement leverage: Large hospital networks and joint-procurement mechanisms (e.g. HERA Incubator, EU4Health) favour suppliers that can deliver uniformly across borders.

2. Cross-Border Collaboration & Knowledge Exchange

- Consortia design freedom: SMEs, RTOs, hospitals, and large OEMs from multiple countries can team up, satisfying Horizon-style eligibility and bringing complementary expertise (materials science, bio-compatibility testing, clinical validation, AI-driven design, etc.).

- Use of existing networks: Leverage the Vanguard Initiative’s ‘3DP Pilot’, EIT Health’s Living Labs, and the Advanced Manufacturing (ADMA) network for accelerated piloting and validation.

- Staff mobility & training: Researchers and engineers can circulate via Erasmus+ and Marie Skłodowska-Curie schemes, embedding knowledge throughout the EU manufacturing base.

3. Alignment with Flagship EU Policies

- European Green Deal: Inkjet additive manufacturing minimises waste, cuts material usage by up to 80 %, and enables localised production—supporting circular-economy and zero-pollution goals.

- Digital Europe & Industry 5.0: Combines digital design twins, AI-optimised jetting paths, and cyber-secure production lines.

- EU Health Union: Contributes to strategic autonomy in critical medical supplies and personalised implants.

- New European Innovation Agenda: Fits the call for deep-tech scale-ups capable of industrial deployment within the Single Market.

4. Regulatory Harmonisation Benefits

- Single conformity assessment: One CE certificate is valid EU-wide, slashing time-to-market by ~18-24 months compared with sequential national approvals elsewhere in the world.

- Common IP regime: Uniform protection via the Unitary Patent (expected entry into force) and EUIPO designs.

- Data governance: Compliance with GDPR and upcoming EHDS (European Health Data Space) enables cross-border clinical data pooling for faster device certification.

5. Access to Europe’s Innovation Ecosystem

- World-class RTOs: Fraunhofer, TNO, VTT, Tecnalia and CEA possess state-of-the-art inkjet pilot lines open for contract research.

- Test-beds & living labs: Use DIH-World and European Digital Innovation Hubs (EDIHs) to validate bio-inks under GMP conditions.

- Standardisation bodies: Engage CEN-CLC TC 438 (Additive Manufacturing) for early standard drafting, boosting acceptance.

6. Funding Synergies & Leverage

- Cascade financing bridge: Inkjet-bioAM’s €540 k can de-risk early TRLs, then scale via EIC Transition/EIC Accelerator (up to €17.5 M per company).

- Combine with InvestEU & EIB: Post-grant debt or equity for pilot lines and factory expansion.

- Regional smart specialisation (S3): Align with ERDF priority areas—up to 40 % co-funding for equipment in regions listed under the “Industrial Modernisation” S3 platform.

7. EU-Scale Deployment & Impact Potential

- Pan-EU supply chains: Distributed micro-factories near clinical hubs reduce logistics emissions and ensure supply resilience.

- Standard clinical protocols: Harmonised post-market surveillance across the EU provides richer real-world evidence for iterative device improvement.

- Export springboard: EU regulatory approval is globally respected, easing entry into Canada, Australia and parts of Latin America via mutual-recognition pathways.

8. Tactical Recommendations for Applicants

1. Build a minimum 3-country consortium to maximise evaluation points on European dimension.

2. Map your proposal explicitly to EU Green Deal KPIs (CO₂ savings, recyclability) and Industrial Strategy (resilience, digitalisation).

3. Plan for CE-marking work-package and engage an EU-based Notified Body early.

4. Include a dissemination strategy utilising EU clusters (AM-Motion, MedicNest) to reach regulators, clinicians and industry.

5. Reserve budget for standardisation participation (CEN/ISO meetings) to shape future AM standards.

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Applying to the “Inkjet-bioAM” call therefore offers not just project funding, but a gateway into the full breadth of the European Single Market, regulatory alignment, and a deeply networked innovation ecosystem—dramatically amplifying the commercial and societal impact achievable versus purely national programmes.