Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

This grant aims to facilitate and fund multinational clinical studies for orphan medical devices and/or highly innovative ('breakthrough') devices, including digital and AI-based tools. The core objective is to generate the necessary clinical data to achieve CE marking under the Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Device Regulation (IVDR). Target recipients are organizations capable of conducting such complex clinical research. This is a SECTOR-SPECIFIC grant focusing on the health and medical device industry. Geographic scope requires studies to be conducted in a minimum of two different countries in the EU or Associated Countries. Key filtering criteria include the nature of the device (orphan or breakthrough), the need for multinational clinical studies, and the ultimate goal of obtaining CE marking. This grant is part of the Horizon Europe Work Programme 2025, indicating a recurring program with specific annual calls.

Financial Structure

Total Funding Budget: The overall budget for this topic is 40,000,000 EUR.
Expected Number of Grants: 5 projects are expected to be funded under this topic.
Grant Amount per Project: Minimum contribution of 6,000,000 EUR and maximum contribution of 8,000,000 EUR.
Currency: EUR.
Funding Type: Grants take the form of lump sum contributions.
Eligible Costs: Lump sum calculation includes estimated direct and indirect project costs. Categories typically include: personnel costs, subcontracting, purchase costs (travel, subsistence, equipment, other goods, works, services), and other cost categories (financial support to third parties, internally invoiced goods/services, research infrastructure access).
Indirect Costs: Calculated at a 25% flat rate applied to direct cost categories that qualify. This is included in the lump sum calculation.
Ineligible Costs: Any costs not eligible under standard Horizon Europe rules.
Co-financing: The total estimated costs of the action must be greater than the estimated Union contributions if the EU contribution does not cover total costs, ensuring compliance with the co-financing principle.
Payment Mechanism: Lump sum contributions are paid per work package upon proper implementation of the work package in accordance with the grant agreement.
Pre-financing: Follows standard Horizon Europe rules.
Mutual Insurance Mechanism: 5-8% of the total lump sum is retained as a contribution to this mechanism.
Financial Reporting/Audits: No reporting of actual costs is typically required. Financial ex-post audits are minimized; checks focus on technical implementation and fulfillment of work package conditions.

Eligibility Requirements

Organization Type & Capacity

Legal entities established in EU Member States or Associated Countries are eligible.
Legal entities established in the United States of America (USA) are eligible to receive Union funding.
Joint Research Centre (JRC) may participate as a member of the consortium.
Small and Medium-sized Enterprises (SMEs) are strongly encouraged to participate.
Applicants must demonstrate capacity to design and conduct multinational clinical studies.

Consortium Requirements

A consortium is required for application.
Clinical studies must be conducted in a minimum of two different countries within the EU or Associated Countries.

Exclusions

Legal entities established in China are not eligible to participate in Innovation Actions in any capacity.
Entities assessed as 'high-risk suppliers' of mobile network communication equipment (and any entities they own or control) are not eligible to participate if the topic is identified as 'subject to restrictions for the protection of European communication networks'. (This specific topic is not explicitly identified as such in the provided text).

Technical & Regulatory Qualifications

Projects must focus on devices needing data in support of CE marking under MDR or IVDR.
Expertise in social sciences and humanities (SSH) disciplines is required, with involvement of SSH experts.
Projects must effectively involve patients, patient organizations, carers, and healthcare professionals in the design of the clinical studies.
If projects use satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS.

Application Process

Submission Type: Two-stage application process.
Submission Platform: Proposals must be submitted via the Funding & Tenders Portal Submission System.
Standard Forms:
- Stage 1: Standard application form (HE RIA IA Stage 1).
- Stage 2: Standard application form (HE RIA, IA).
Clinical Study Annex: Applicants must provide detailed information on their clinical studies in a dedicated annex using the template provided in the submission system.

Deadlines & Timeline

Call Opening: 2025-05-22.
Stage 1 Submission Deadline: 2025-09-16 00:00:00+0000.
Stage 2 Submission Deadline: 2026-04-16 16:00:00+0000.
Indicative Timeline for Evaluation and Grant Agreement: Described in Annex F of the Work Programme General Annexes.

Documentation Requirements

Proposals should include a detailed budget table (HE LS).
First-stage applications under the blind evaluation pilot must not disclose their organization names, acronyms, logos, nor names of personnel in the proposal abstract and Part B.

Support & Guidance

Online Manual: Provides guidance on procedures from proposal submission to grant management.
Horizon Europe Programme Guide: Detailed guidance on structure, budget, and political priorities.
Funding & Tenders Portal FAQ: Answers to frequently asked questions.
National Contact Points (NCPs): Provide guidance, practical information, and assistance.
Enterprise Europe Network: Advice for businesses, especially SMEs.
IT Helpdesk: For technical issues with the Funding & Tenders Portal.
European IPR Helpdesk: Assistance on intellectual property issues.
Partner Search: Tool to find partner organizations.

Post-Award Requirements

Lump Sum Release: Payments are contingent upon the proper implementation of corresponding work packages.
Monitoring & Evaluation: Focus on technical implementation, fulfillment of work package conditions, ethics, research integrity, dissemination, IP management, and gender equality.
Post-Market Surveillance (PMS) & PMCF: For orphan devices, a robust PMS system and a detailed Post-Market Clinical Follow-up (PMCF) plan are essential for continued assessment and data collection.

Evaluation Criteria

Two-Stage Evaluation Process

Proposals are evaluated in two stages, with the first stage being a blind evaluation (applicants must not disclose organization names, acronyms, logos, or personnel names in the abstract and Part B of the first-stage application).

Stage 1 Award Criteria (First Stage)

Excellence: Threshold of 4.
Impact: Threshold of 4.
Overall Threshold: Applies to the sum of the two individual scores, set to ensure total requested budget of proposals admitted to stage 2 is as close as possible to four times the available budget, and not less than three and a half times the available budget.

Stage 2 Award Criteria (Second Stage)

Excellence: Threshold of 4.
Impact: Threshold of 4.
Implementation: Threshold of 4.
Cumulative Threshold: 12.

Specific Evaluation Focus

Quality of proposal: Assessed in terms of excellence, expected impact, and quality and efficiency of implementation.
Budget estimation: Experts (with financial know-how) will check the budget estimate for each work package based on benchmarks and assess if resources and lump sum breakdown allow for activities and outputs.
Resource alignment: Verification that proposed resources and lump sum shares are sufficient to achieve described activities and expected outputs.
Cost justification: Proposals must declare adherence to own accounting practices for budget preparation and include only eligible costs.
Scientific/technical performance: Emphasis on the output of projects.
Societal impact: Expected outcomes include benefits for patients, healthcare providers, and the EU health industry, with a focus on health outcomes and reducing health inequities.
Ethical considerations: Compliance with ethical standards, especially for vulnerable populations and gender-sensitive/intersectional approaches in studies.

Compliance & Special Requirements

Regulatory Compliance

Projects must comply with the Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR) for CE marking.
Authorization for clinical studies by more than one national competent authority may be necessary for multinational studies.
If using satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must use Copernicus and/or Galileo/EGNOS.

Ethical Standards

Adherence to ethical standards and requirements is paramount, especially for clinical investigations.
Proposals must adopt a gender-sensitive and intersectional approach in patient selection, considering individual characteristics (gender, sex, race, ethnicity, disability, age) and socioeconomic, lifestyle, and behavioral factors.
Effective contribution and involvement of Social Sciences and Humanities (SSH) disciplines and experts are required to enhance societal impact.

Device-Specific Definitions & Criteria

Orphan Device: Defined as a device specifically intended to benefit patients in the treatment, diagnosis, or prevention of a disease/condition present in not more than 12,000 individuals in the EU per year, AND meets one of two criteria: insufficiency of alternative options OR provides major clinical benefit compared to alternatives.
Highly Innovative ('Breakthrough') Device: Expected to provide major clinical benefits for life-threatening, seriously debilitating, or chronic diseases, addressing unmet medical needs. This includes devices using digital tools and AI.
Clinical Studies: Must demonstrate safety and performance of the device(s) and support CE marking.

Intellectual Property & Data

Projects must comply with Intellectual Property (IP) policies as per Horizon Europe rules (not detailed in provided text, but mentioned in evaluation focus).
Data protection and privacy are implicitly required for clinical studies involving patient data.

Unique Aspects & Challenges

The grant addresses the challenges of generating clinical data for orphan and breakthrough devices due to small patient populations and complex regulatory paths.
Blind evaluation in Stage 1 is a pilot initiative.
Lump sum funding model simplifies financial management, shifting focus to technical implementation.
Strong encouragement for SME participation underscores the importance of innovation from smaller entities.
Potential synergies with ERDERA (European Rare Diseases Research Alliance) and EU4Health programme should be explored for orphan devices.

Risk Management & Post-Market

A detailed PMCF plan is crucial for orphan devices, especially given acceptable limitations in pre-market clinical data. This plan should address identified limitations, generate appropriate post-market data, and include projections and milestones.
Manufacturers must have an appropriate Post-Market Surveillance (PMS) system in place.

Grant Details