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Grant Analysis

Purpose & Target

This grant aims to support the digitalisation of conformity assessment procedures for medical devices and in vitro diagnostic medical devices, improving efficiency and market access in the EU. - The primary targets are legal entities involved in medical device development and manufacturing, including Notified Bodies (NBs), device developers, and manufacturers, with a specific focus on Small and Medium-sized Enterprises (SMEs). Projects should involve a good representation of different NBs (small, large, public, private). - SECTOR-SPECIFIC - Geographic scope and any location requirements: Projects must be implemented in Europe and Associated Countries. Coordinators must be established in an EU Member State or Associated Country. Legal entities established in the United States of America may exceptionally participate and receive funding. - Key filtering criteria for initial grant screening: Focus on digitalisation, medical devices/IVDR, and improving conformity assessment procedures. Must be a collaborative project. - Grant frequency and program context: This is a single-stage call for 2025, part of the Horizon Europe program (Cluster 1 - Health), specifically a Coordination and Support Action (CSA). It supports the strategic objective of maintaining an innovative, sustainable, and competitive EU health industry and fostering the digital transition.

Financial Structure

This grant provides funding as a lump sum contribution.
The total budget for this specific topic (HORIZON-HLTH-2025-01-IND-02) is 4,000,000 EUR.
The minimum contribution per grant is 4,000,000 EUR.
The maximum contribution per grant is 4,000,000 EUR.
Eligible costs, which approximate actual costs, include:
- Personnel costs (employees, direct contractors, seconded persons, SME owners, natural person beneficiaries).
- Subcontracting costs.
- Purchase costs (travel, subsistence, equipment, other goods, works, and services).
- Other cost categories (financial support to third parties, internally invoiced goods/services, transnational/virtual access to research infrastructure, PCP/PPI procurement, Euratom Cofund staff mobility, ERC additional funding).
Ineligible costs must be excluded.
Indirect costs are calculated by applying a 25% flat rate to eligible direct cost categories.
Payments are made based on the completion of work packages, not on actual incurred costs.
Pre-financing will follow standard Horizon Europe rules.
5% to 8% of the total lump sum is retained as a contribution to the Mutual Insurance Mechanism.
Co-financing is implied: the total estimated costs of the action must be greater than the estimated Union contribution.

Eligibility Requirements

Organizational Type and Status

Legal entities established in an EU Member State or Associated Country are eligible to coordinate.
Legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity and are eligible for funding.
High-risk suppliers of mobile network communication equipment (and entities they own or control) are not eligible to participate as beneficiaries, affiliated entities, or associated partners.

Scope of Activities

Proposals must address the digitalisation of all steps of the MDR/IVDR procedures, from manufacturer's pre-application activities to certificate issuance by a Notified Body.
Projects must involve all actors in the conformity assessment procedure, including manufacturers, Notified Bodies (NBs), EU reference laboratories, expert panels, and agencies involved in consultation.
Projects must include a good representation of different NBs (small, large, public, private) and a mix focusing on medical devices and in vitro diagnostic medical devices.
Actions must be performed under the current regulatory framework and must not involve changing MDR/IVDR requirements.
Governance of a potential IT infrastructure developed in Europe and Associated Countries is outside the scope of the topic.

Partnership Requirements

Collaboration with relevant stakeholders (NBs, manufacturers, European Commission, others) is expected, indicating a consortium is required.

Application Process

Application Timeline

The submission session opened on 2025-05-22.
The application deadline is 2025-09-16T00:00:00+0000.
This is a single-stage submission procedure.

Required Documentation and Submission

Applications must use the Standard application form (HE CSA) available in the Submission System.
A Detailed budget table (HE LS) must be used to prepare the estimated budget.
The Standard evaluation form (HE CSA) will be used for evaluation with necessary adaptations.
Submission is done via the Funding & Tenders Portal's Electronic Submission Service.

Post-Award Requirements

Grant agreements will outline legal and financial setup, including lump sum conditions.
Payments for lump sum contributions per work package are made to the coordinator upon successful completion of work packages.
If work package conditions are not met, payments are not made and the grant may be reduced.

Application Assistance

Applicants can consult the Online Manual for procedures, Horizon Europe Programme Guide for detailed guidance, and Funding & Tenders Portal FAQ.
Support is available from the Research Enquiry Service, National Contact Points (NCPs) (including in non-EU/non-associated countries), and the Enterprise Europe Network (EEN) for businesses, especially SMEs.
IT Helpdesk is available for technical submission issues.
European IPR Helpdesk assists with intellectual property.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk advise on standardisation.
Partner Search tools are available to find partner organizations.

Evaluation Criteria

General Evaluation Criteria

Proposals will be evaluated by external independent experts based on three criteria: Excellence, Impact, and Quality and efficiency of the implementation.

Scoring and Thresholds

The threshold for each criterion (Excellence, Impact, Implementation) will be 4.
The cumulative threshold for all criteria will be 12.

Financial Evaluation

Experts with financial expertise will check the budget estimate for each work package.
Budget estimates will be assessed against relevant benchmarks (market prices, statistical data, historical data on similar actions) to ensure resources proposed and lump sum split align with achieving activities and expected outputs.
Beneficiaries must declare that their own accounting practices were followed for budget preparation.

Project Quality and Coherence

The proposal must detail activities covered by each work package and all related resources.
The detailed cost estimation per work package and per beneficiary/affiliated entity must only include costs eligible for an actual costs grant and exclude ineligible costs.

Compliance & Special Requirements

Regulatory and Ethical Compliance

Projects must operate strictly within the current regulatory framework of Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) without altering their requirements.
Adherence to high data privacy and cybersecurity standards is expected.
Ethical standards and research integrity are subject to checks and audits.
Projects are encouraged to contribute to the strategic goal of greener medicines by considering environmental issues.

Financial and Technical Oversight

Financial reporting is simplified due to the lump sum model; the focus of checks, reviews, and audits will be on the technical implementation and successful completion of work packages.
Beneficiaries must adhere to their national accounting rules, even without direct cost reporting to the granting authority.
Proposals must address the need for consensus building activities among diverse stakeholders (manufacturers, NBs, agencies, etc.).

Geographic Restrictions

Legal entities assessed as high-risk suppliers of mobile network communication equipment (as per EU toolbox on 5G cybersecurity reports) are not eligible.

Strategic Alignment

Projects should align with the broader Horizon Europe objectives, including strengthening the resilience of the single market, addressing strategic dependencies, gaining technological sovereignty, and accelerating the green and digital transitions in the EU health industry.

Grant Details