EIT Health - Innovation Validation Call 2027
Accelerating the clinical validation, regulatory approval and market launch of innovative digital and AI-powered medical technologies that address unmet healthcare needs.
TYPE OF PROJECTS TO BE FUNDED: Collaborative innovation projects aimed at accelerating the clinical validation, regulatory approval and commercialisation of patient-centred digital and AI-powered medical technologies. Funded activities include pivotal clinical trials to demonstrate safety and efficacy, collection and analysis of clinical evidence, final technical development and verification testing, intellectual property protection, preparation of regulatory submissions and technical dossiers, and market readiness activities such as business model development, pricing strategies and go-to-market planning. Projects must support innovations at an advanced development stage and demonstrate a credible pathway towards regulatory authorisation and market launch.
SECTORS / DOMAIN: Life sciences and healthcare, digital health, medical technologies, AI-powered healthcare solutions, digital medical devices and in-vitro diagnostics. Target applications include patient screening, diagnosis, treatment and monitoring. The call focuses on innovations that directly address unmet medical needs and deliver measurable patient benefits.
INDIVIDUAL OR CONSORTIUM: Applications must be submitted by consortia comprising at least two independent legal entities established in different countries. Consortia must represent at least two sides of the Knowledge Triangle (industry, education and research), with mandatory participation from at least one industry organisation. The consortium must be led by a legally registered, for-profit Commercialising Entity, such as an SME or larger company, possessing the capabilities and legal rights to commercialise and scale the proposed innovation. Individual applicants are not eligible.
SPECIFIC ELIGIBILITY REQUIREMENTS: Funding is generally available to legal entities established in EU Member States, Overseas Countries and Territories linked to Member States, Horizon Europe Associated Countries and certain eligible low- and middle-income countries, subject to Horizon Europe eligibility rules. Entities established elsewhere may receive funding only where their participation is considered essential by EIT. The proposed innovation must qualify as a digital medical device or in-vitro diagnostic device under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR), be at Innovation Maturity Level (IML) 6 overall and be pre-CE marked for the intended application addressed by the project. The project must aim to reach IML 7. If the Commercialising Entity is a micro or small enterprise, it must have at least four eligible full-time equivalent permanent employees, a full-time CEO, and have raised at least €250,000 in external dilutive funding during the previous three years, reduced to €150,000 for entities established in EIT Regional Innovation Scheme countries. Such enterprises must not have publicly traded shares or be undergoing an initial public offering. Applicants must demonstrate appropriate intellectual property rights, financial and operational capacity, and compliance with ethical and regulatory requirements. A valid Participant Identification Code (PIC) is required. The Commercialising Entity must sign a Financial Sustainability Contribution Agreement with EIT Health.
SPECIFIC TOPICS OR CHALLENGES: The call targets clinically relevant digital and AI-powered healthcare innovations that address unmet medical needs and improve patient outcomes across screening, diagnosis, treatment or monitoring. Projects must focus on advanced clinical validation, generation of robust safety and efficacy evidence, regulatory readiness and commercialisation. Mandatory outcomes include submission of a regulatory approval dossier, registration or filing of at least one intellectual property asset, and a credible pathway towards launching an innovation generating at least €10,000 in sales revenues and benefiting at least 150,000 European patients or citizens within three years after project completion. For micro and small Commercialising Entities, attracting at least €500,000 in public or private investment within the specified monitoring period is also mandatory. Wellness or lifestyle applications, non-medical devices, solutions unrelated to medical conditions or treatment, and healthcare management software without a direct impact on patient care are excluded.
PROJECTS DURATION: Maximum 20 months, with the official project start date of 1 May 2027 and a maximum end date of 31 December 2028.
BUDGET, FUNDING RATES AND PAYMENT CONDITIONS:
Funding rate: Up to 50% of total eligible project costs. Consortia must secure the remaining 50% through non-EIT Health co-funding sources.
Budget conditions / limitations: Total call budget of up to €5,100,000, supporting up to six projects. Maximum EIT Health contribution of €850,000 per project. Where the Commercialising Entity is a micro or small enterprise, it must receive between €400,000 and €500,000 of the awarded grant. Eligible costs must comply with the Horizon Europe Model Grant Agreement. Subcontracting is permitted only for a limited part of the project and must not replace the consortium's own implementation capacity. The Commercialising Entity must enter into a mandatory Financial Sustainability Contribution Agreement with EIT Health. Micro and small enterprises are subject to a Grant to Option to Equity Agreement, while medium and large enterprises must enter into a Revenue Sharing Agreement. Under the latter, revenue sharing obligations arise when commercial revenues exceed €10,000 within five years after project completion, with payments based on the EIT Health funding received plus an agreed mark-up of at least 15%.
Payments: Funding follows a cost-reporting model, with annual pre-financing and balance payments. Standard pre-financing may amount to up to 25% of each beneficiary's annual EIT Health funding allocation, with additional pre-financing arrangements of up to 50% of the annual grant for micro and small enterprises commercialising the solution. The first pre-financing payment is made within three months following completion of contracting and project kick-off. Annual balance payments are made following cost verification and performance assessment, generally within three months of the relevant checks and no later than September of the following year. Payments are conditional on contractual compliance, eligible expenditure and satisfactory project implementation.
Links
Closes
13/01/2027
Max funding per project
850.000€