EIT Health Innovation Validation Call
Funds clinical validation and regulatory approval for AI-enabled medical devices reaching market readiness.
Eligibility · EU member states
⚠This may reflect a past cycle — verify the current call on the funder's site.
The EIT Health Innovation Validation Call is an annual EU co-financing programme that accelerates late-stage digital, data-driven, and AI-enabled medical devices through clinical validation, CE-mark regulatory submission, and commercial launch. The 2026 cycle ran from 25 February 2026 to 6 May 2026 and is now closed. Funded projects must address solutions regulated under the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), and target an Innovation Maturity Level of 6 at application with IML 7 expected at project completion—broadly equivalent to TRL 6–7 for software-based medical devices.
Grants cover up to 50% of total project costs, with a maximum award of €850,000 per project and a mandatory allocation of €400,000–€500,000 to a micro or small enterprise within the consortium. Projects run for up to 24 months. Eligible consortia must include a minimum of two organisations from different EU countries, span at least two sides of the Knowledge Triangle (industry, research, education), and be led by a commercialising company—universities cannot hold the lead role. Impact thresholds require that funded solutions reach at least 150,000 EU patients and generate a minimum of €10,000 in revenue within three years of project completion.
Competitive applications are expected to present a credible Go-to-Market strategy, a realistic regulatory pathway to CE marking, and strong clinical evidence underpinning the pivotal study design. Organisations seeking to position for the 2027 cycle should audit their IML and consortium composition now, confirm match-funding capacity (minimum 50% of project budget), and engage an EIT Health partner institution early—partner involvement strengthens both eligibility and scoring.
Digital, data and AI-enabled medical devices regulated under MDR/IVDR. Clinical validation through pivotal studies, CE-mark regulatory submission, product finalization, market readiness, and commercial strategy.
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