EIT Health Innovation Validation 2027: up to €850,000 for consortia for clinical validation of digital and AI medical devices, Ukraine eligible, apply by 13 January

EIT Health has announced the Innovation Validation 2027 call to support the clinical validation and market entry of digital and artificial intelligence-powered medical technologies. The grant addresses the critical transition stage for solutions that need to execute clinical trials, generate evidence for safety and efficacy, and prepare regulatory submissions under MDR and IVDR regulations.

The call features a total budget of €5,100,000, providing up to €850,000 per project. EIT Health provides grant co-funding for up to 50% of the total project costs, supporting up to six cross-border collaborative projects. The deadline to submit proposals is 13 January 2027.

What is funded

The call provides funding for activities directly tied to clinical validation, such as pivotal clinical studies for digital and AI-driven medical devices. Supported projects must collect the clinical evidence required to demonstrate clinical efficacy and safety in real-world environments, as well as prepare regulatory documentation such as CE-mark application dossiers.

Financing also covers final technical adjustments, market readiness, and commercialization strategies. Projects must focus on solutions currently at Innovation Maturity Level (IML) 6, with the mandatory objective of advancing them to IML 7 by the conclusion of the funding period.

Who can apply

Eligible proposals must be submitted by international consortia comprising at least two independent legal entities from different eligible countries. The consortium must represent at least two sides of the knowledge triangle, integrating business enterprises with research institutes or higher education institutions.

The project must be officially led by the commercialising company. Participating members can include small and medium-sized enterprises (SMEs), startups, universities, and research organizations seeking to validate compliant medical devices.

Conditions and requirements

The commercialising lead partner must sign a Financial Sustainability Contribution Agreement as a condition of receiving the grant. If the commercialising entity is categorized as a micro or small enterprise, it must be allocated between €400,000 and €500,000 of the total grant amount.

Supported solutions must show potential to reach and impact at least 150,000 European patients or citizens. Furthermore, the technology must aim to be commercially launched and generate a minimum of €10,000 in revenues within three years following the end of the project.

Practical tip. Validate that your technological solution strictly complies with IML 6 maturity criteria and that all initial bench testing is complete prior to drafting the proposal. Consortia should secure clinical partners with immediate access to appropriate patient populations to guarantee that clinical trials can meet the timeline for reaching IML 7.

How to apply

Before applying, all participating partner organizations must obtain a nine-digit Participant Identification Code (PIC) by registering on the EU Funding and Tenders portal. Consortia can verify existing registration status directly on the portal if an organization already has a code.

Final application files must be completed and submitted directly through EIT Health’s dedicated online application platform. Applicants must submit full project plans, validation methodologies, and budget allocations before the call closing date on 13 January 2027.

Applications are submitted on the donor’s page: eithealth.eu.