Innovation Validation Call 2027

Innovation Validation Call 2027 (EIT Health under Horizon/EIT) funds late-stage digital and AI-enabled medical devices to support clinical validation, regulatory preparation and market readiness. Consortia must be company-led with at least two organisations from different countries and demonstrate Innovation Maturity Level 6 progressing to IML7 by project end. Total call budget €5.1 million, EIT Health funds up to 50% of eligible costs with a maximum grant of €850,000 per project and required co‑financing; micro or small commercialising entities must receive €400,000–€500,000 of the grant and the commercialising entity must sign a Financial Sustainability Contribution Agreement. Single-stage applications close 13 January 2027 at 16:00 Brussels time and must be submitted via the EIT Health application platform with organisations registered in the EU Funding & Tenders Portal (PIC).

What it funds

Scope and activities

Grants for clinical validation and market preparation of digital and AI-enabled medical technologies (MDR/IVDR). Funded activities include pivotal clinical studies, regulatory submission (CE-mark dossiers), product finalisation, market readiness and commercial strategy.

Footnotes

1. 1Full call text, templates and submission portal links are on the EIT Health opportunity page and the EU Funding & Tenders portal: eithealth.eu and ec.europa.eu

Key facts

Who can apply and eligibility

Funding details and financial conditions

Selection and evaluation process

Project requirements, expected outcomes and KPIs

Application mechanics and templates

Application is submitted through the EIT Health Application Platform. Applicants must first register their organisation in the EU Funding & Tenders Portal to obtain a PIC. The official call document and supporting documents (including application templates, budget templates and guidance) are available from the EIT Health call page and the EU Portal listing. Applicants should consult the official call document for detailed format, required annexes and evaluation criteria.

Administrative and technical details to prepare

Project stage, sector and expected maturity

Deadlines, events and contact opportunities

Success likelihood, application stages and co-funding

Mentioned countries and geographic scope

The call is administered by EIT Health within the Horizon/EIT framework and is targeted to applicants within Horizon-eligible countries. The call text requires consortium partners from different countries (no exhaustive country list in scraped text). Geographic scope: primarily EU / Horizon Europe eligible countries; applicants must register on the EU Portal (PIC) and be able to participate in EIT Health programmes. No individual countries were explicitly enumerated in the scraped content.

Templates and application form structure guidance

Application templates, budget templates, and guidance documents are provided by EIT Health via the official call package. The typical application includes: administrative information; project summary and keywords; problem statement and clinical need; solution description and regulatory classification; innovation maturity level (IML) justification; clinical validation plan and study design; regulatory pathway and dossier plan; exploitation and commercialisation plan with KPIs (patient reach and revenue targets); work packages, milestones and deliverables; consortium roles and CVs; detailed budget and justification; ethical approvals or plan; data management and ELSI considerations; and required legal declarations and signatures.

Applicants should consult the official call document for exact file formats, page limits, required annexes and signed declarations. The application platform offers step-by-step instructions and upload locations for templates.

Summary and practical advice

This call is tailored to commercialising teams developing digital or AI-enabled medical devices that are past early development and need funding specifically to run pivotal clinical validation, prepare regulatory submissions (CE marking), finalise the product and deploy a market readiness strategy. The call requires consortia with cross-border partners and at least two Knowledge Triangle sides. EIT Health offers up to 50% funding of project costs with a maximum grant of €850,000 per project and requires co-funding for the balance. Micro and small enterprises have a stipulation on minimum grant share and must conclude a Financial Sustainability Contribution Agreement. Applicants should secure consortium partners, clinical sites and co-funding before application, obtain a PIC, and prepare a complete clinical and regulatory plan demonstrating pathway to IML 7 and projected patient impact and revenues within three years. Shortlisted applicants will be invited to an online pitch and projects are subject to an ELSI review.

For the official call document and supporting documents consult the EIT Health call page and the EU Funding & Tenders Portal EIT Health Innovation Validation Call 2027 EU Portal listing. 1

Footnotes

1. 1Primary call information and official documents are maintained by EIT Health and the EU Funding & Tenders Portal. Applicants must follow instructions and templates included in the official call package available via those pages.

Innovation Validation Call 2027

Executive Summary

Innovation Validation Call 2027 is an EIT Health cascade funding opportunity for late-stage digital and artificial intelligence enabled medical technologies. It is intended to close the funding gap between a validated innovation and market launch by supporting pivotal clinical evidence, regulatory preparation, final product development, market readiness and commercialisation planning 1.

The opportunity is best suited to a company-led consortium that has a digital or AI-enabled medical device within the scope of the Medical Device Regulation or In Vitro Diagnostic Medical Device Regulation, has reached Innovation Maturity Level 6, and can reach Innovation Maturity Level 7 by the end of the funded project.

The total call budget is €5.1 million. EIT Health will fund up to 50 percent of eligible project costs, subject to a maximum grant of €850,000 per project. The call page does not state the number of projects expected to be funded, so the final number will depend on requested amounts and the results of evaluation 1.

Opportunity Identity

Purpose and Scope

The call supports healthcare innovations that are close to clinical and commercial deployment but require additional evidence, regulatory work and market preparation. The main purpose is to enable solutions to progress from Innovation Maturity Level 6, representing a late validation stage, to Innovation Maturity Level 7, representing a market-ready stage within the EIT Health innovation framework.

Supported work may include pivotal clinical studies, clinical evidence generation, regulatory submission activities, preparation of a CE marking dossier, product finalisation, market readiness activities and commercial strategy development.

The opportunity is focused on digital and AI-powered medical technologies rather than general health research, early-stage discovery, basic research or non-medical digital products. Applicants should demonstrate that the proposed technology is a medical device or in vitro diagnostic device within the relevant regulatory framework and that the proposed work is necessary to achieve clinical, regulatory and commercial progress.

Who Can Apply

Eligible applications must be submitted by a consortium meeting all of the following structural conditions:

The available information does not provide a separate exhaustive list of eligible legal entity types or countries. Applicants should confirm the precise country and entity eligibility rules in the official call document and supporting documents before finalising the consortium.

Eligible Technology and Maturity

Funding and Financial Conditions

EIT Health will provide funding of up to 50 percent of the total project budget, with a maximum grant amount of €850,000 per project 1. The applicant must therefore provide co-financing or other eligible project resources for the remaining project costs. The published information does not specify whether the non-EIT Health contribution must be cash, in-kind, or a combination, and this must be checked in the call documents.

A project receiving the maximum grant of €850,000 would normally need an eligible total project budget of at least €1.7 million if the 50 percent funding rate is applied. This is an illustrative calculation and does not establish a minimum project budget, because the call page does not publish one.

The commercialising entity must sign a Financial Sustainability Contribution Agreement. For a micro or small enterprise acting as the commercialising entity, the grant received by that entity must be between €400,000 and €500,000. The agreement may create additional financial or corporate obligations, and applicants should examine the agreement template before committing to the call 4.

Expected Impact and Commercial Outcomes

The solution must have the potential to impact at least 150,000 European Union patients or citizens. Applicants should quantify this potential with a credible target population, clinical use case, healthcare pathway, adoption strategy and route to scale.

The project should aim to place the solution on the market and generate at least €10,000 in revenue within three years after the funding period. This requirement means that proposals should include a credible commercialisation plan, regulatory pathway, market access strategy, pricing or reimbursement rationale, customer segments and post-project implementation plan.

The impact and revenue expectations make this opportunity unsuitable for proposals focused only on research outputs, publications, prototype development or long-term exploratory technology development without a defined route to clinical use and market entry.

Eligible Activities

The call does not provide a complete cost eligibility schedule in the available material. Costs should therefore be mapped carefully to the approved work plan and checked against the project grant agreement before inclusion in the budget 3.

Application Process

Applicants must complete the following process:

The EU Funding and Tenders Portal registration is required for organisational identification, while the application itself is submitted through the EIT Health application platform. Applications submitted through an alternative channel may be treated as inadmissible.

Evaluation and Selection

The process is single stage and includes several subsequent assessment steps:

The published extract does not disclose the detailed weighting of the evaluation criteria. Applicants should expect the proposal to be assessed on the strength of the innovation, clinical and regulatory plan, maturity progression, market opportunity, consortium capability, expected patient impact, commercialisation potential, feasibility, budget credibility and ethical, legal and social implications.

Key Dates

Recommended Proposal Strategy

Key Risks and Conditions to Verify

Overall Assessment

This is a highly targeted scale-up and market validation opportunity for company-led European consortia with a mature digital or AI-enabled medical device. It offers a relatively substantial grant of up to €850,000, but the 50 percent funding ceiling requires significant co-financing and the lead company must accept additional financial sustainability obligations.

The strongest applicants will already have a clinically credible product, a defined MDR or IVDR pathway, access to clinical validation capabilities, a realistic route to market and evidence supporting the required patient impact and post-project revenue objectives. Early-stage concepts, technologies below Innovation Maturity Level 6, non-medical software and projects without a commercialising company lead are unlikely to fit the call.

The decisive submission deadline is 13 January 2027 at 16:00 Brussels time. Applicants should use the official EIT Health call documents and application platform as the controlling sources for final eligibility, budget, contractual and submission requirements 5.

Source Notes

The opportunity is published through the EU Funding and Tenders Portal and detailed by EIT Health, the implementing organisation. The call is linked to the EIT Health Business Plan 2026-2028 and Horizon Europe framework funding 2.

Footnotes

1. 1Primary sources: EU Funding and Tenders Portal opportunity and EIT Health Innovation Validation Call 2027. The EIT Health page provides the detailed scope, eligibility, funding and expected outcome information.
2. 2The call page identifies the opportunity as part of the EIT Health Business Plan 2026 to 2028, project acronym EIT Health 26-28, grant agreement number 101269968, under Horizon Europe and the EIT framework.
3. 3The published material does not state a fixed project duration, detailed eligible cost categories, payment schedule, indirect cost rules, or a complete scoring breakdown. Applicants should verify these matters in the official call document, application form, frequently asked questions and project grant agreement before submission.
4. 4The call information identifies a Financial Sustainability Contribution Agreement as a mandatory obligation for the commercialising entity. The exact financial, equity, option or repayment consequences should be reviewed in the agreement template before applying.
5. 5The official opportunity metadata and EIT Health opportunity page state the deadline as 13 January 2027 at 16:00 Brussels time. Some secondary listings display different dates, so applicants should rely on the official portal and EIT Health application platform.