Facilitating the conduct of multinational clinical studies of orphan devices and/or of highly innovative (“breakthrough”) devices

The grant opportunity titled "Facilitating the conduct of multinational clinical studies of orphan devices and/or of highly innovative (‘breakthrough’) devices" is part of Horizon Europe's Health Cluster. It is designed to support multinational clinical studies that assess orphan devices intended for rare diseases and breakthrough medical technologies, which may include digital and AI-based tools.

Eligible applicants include small and medium-sized enterprises (SMEs), research institutions, universities, and public-private partnerships. The Joint Research Centre (JRC) can also participate in consortia. The funding type is a grant categorized under Horizon Europe’s Research and Innovation Actions, specifically HORIZON-RIA, and involves lump-sum financial support with an expected contribution of between €6 million and €8 million per project.

This opportunity mandates that applicants form a consortium, reflecting a requirement for multinational collaboration across at least two EU or associated countries. The geographic scope includes entities from EU and associated countries, with specific provisions allowing participation from legal entities in the United States.

The grant primarily targets the biotech and medtech sectors, focusing on the development of orphan devices and breakthrough devices. This includes addressing unmet medical needs related to rare diseases and conditions, alongside life-threatening or chronic diseases. The project stage is aimed at validation and demonstration, providing necessary data to support regulatory approval.

Applications must be submitted through a two-stage open call process, with the first deadline occurring on September 16, 2025, followed by a second on April 16, 2026. The nature of support is purely monetary, and the project aims to improve market positions for EU and associated companies while enhancing patient access to innovative medical devices.

There are no co-funding requirements, but participants must adhere to specific guidelines for proposal submissions, ensuring practices align with Horizon Europe’s objectives. The estimated success rate for applications is competitive, typically ranging from 10% to 39%.

In summary, this grant aims to strengthen the EU health industry by facilitating the development and validation of medical devices through multinational clinical studies. It encourages SMEs' participation and collaboration among various stakeholders, focusing on generating robust clinical evidence to facilitate market access and improve healthcare outcomes.

This is a Horizon Europe call for proposals, specifically HORIZON-HLTH-2025-03-IND-03-two-stage, which falls under Cluster 1 Health. The call seeks to fund Research and Innovation Actions (RIA) aimed at facilitating multinational clinical studies of orphan devices and highly innovative breakthrough devices, including those utilizing digital and AI technologies. The goal is to maintain an innovative, sustainable, and competitive EU health industry.

The expected outcomes of funded projects include:

Increased hands-on experience for healthcare providers in using orphan and breakthrough devices, with timely access to these devices.
Collection of scientific evidence by developers and manufacturers on their device interventions.
Benefits for patients through the development, study, and use of these devices.
Improved market position for EU and associated country companies, along with enhanced knowledge of conducting multinational clinical studies.

The scope of the call focuses on multinational clinical studies of orphan devices and highly innovative breakthrough devices, including digital and AI-based tools. It addresses the gap in support for orphan devices, which are intended for rare diseases or conditions and often used in small patient populations, making clinical data generation challenging. Highly innovative breakthrough devices are also considered if they offer major clinical benefits for life-threatening, debilitating, or chronic conditions, addressing unmet medical needs where no satisfactory diagnosis, prevention, or treatment exists in the EU.

Proposals should demonstrate activities that support CE marking under the Medical Device Regulation (MDR) or in vitro Diagnostic Medical Devices Regulation (IVDR), including:

Designing and conducting multinational clinical studies in at least two EU or associated countries to demonstrate device safety and clinical performance.
Presenting a sound clinical study feasibility plan with appropriate patient selection and realistic recruitment plans.
Adopting a gender-sensitive and intersectional approach, considering individual characteristics and socioeconomic factors, requiring the effective contribution of social sciences and humanities (SSH) disciplines.
Demonstrating potential clinical benefit for patients and healthcare providers, including quality of life and patient-reported outcomes.
Involving patients, patient organizations, carers, and healthcare professionals in the design of clinical studies.
Identifying, collecting, and recording relevant good practices and experiences in multinational clinical studies, providing recommendations and lessons learned.
Developing a regulatory strategy and interaction plan for engaging with regulators and other relevant bodies, such as the EMA and Health Technology Assessment bodies.

Participation of SMEs is strongly encouraged. Synergies with actions implemented under ERDERA and the EU4Health programme should be explored for orphan and highly innovative devices relevant to rare disease patients. The Joint Research Centre (JRC) may participate as a member of the consortium.

Applicants must provide details of their clinical studies in a dedicated annex using the provided template.

General conditions for participation include:

Applicants must not disclose their organization names, acronyms, logos, or personnel names in the proposal abstract and Part B of their first-stage application, adhering to the blind evaluation pilot guidelines.
Admissibility conditions, proposal page limits, and layout requirements as described in the Horizon Europe Work Programme General Annexes.
Eligible countries as described in Annex B of the Work Programme General Annexes, with specific provisions for non-EU/non-Associated Countries.
US entities are eligible for Union funding.
Projects using satellite-based data must utilize Copernicus and/or Galileo/EGNOS.
Financial and operational capacity and exclusion criteria as described in Annex C of the Work Programme General Annexes.
Evaluation and award criteria, scoring, and thresholds as described in Annex D of the Work Programme General Annexes.
Submission and evaluation processes as described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement as described in Annex F of the Work Programme General Annexes.
Eligible costs will take the form of a lump sum.
Legal and financial setup of the grants as described in Annex G of the Work Programme General Annexes.

The call provides a budget of 40,000,000 EUR for the year 2025. It is a two-stage submission process, with the first deadline on September 16, 2025, and the second on April 16, 2026. The indicative contribution per project is between 6,000,000 to 8,000,000 EUR, and it is expected that approximately 5 grants will be awarded. The call opened for submission on May 22, 2025.

The call aims to bridge the gap in support for orphan devices and breakthrough medical technologies by funding multinational clinical studies. It seeks to improve patient outcomes, enhance healthcare provider experience, and strengthen the EU's health industry by generating robust clinical evidence and facilitating market access for innovative medical devices. The emphasis on involving SMEs, patients, and healthcare professionals ensures that the research is relevant, impactful, and aligned with societal needs. The lump sum funding model aims to simplify financial management and focus on achieving project objectives.

Eligible Applicant Types: The eligible applicant types include, but are not limited to, healthcare providers, developers and manufacturers of medical devices, small and medium-sized enterprises (SMEs), patient organizations, and research institutions. The Joint Research Centre (JRC) may also participate as a member of the consortium. The participation of SMEs is strongly encouraged. Any legal entity established in the United States of America is also eligible to receive Union funding.

Funding Type: The funding type is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA) with eligible costs taking the form of a lump sum. The Model Grant Agreement is a HORIZON Lump Sum Grant [HORIZON-AG-LS].

Consortium Requirement: The opportunity requires a consortium of multiple applicants, with multinational clinical studies to be conducted in a minimum of two different countries in the EU or Associated Countries.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes the EU and Associated Countries. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. Any legal entity established in the United States of America is also eligible to receive Union funding.

Target Sector: The target sector is health, specifically focusing on medical devices and in vitro diagnostic medical devices, including orphan devices and highly innovative ("breakthrough") devices, including digital and Artificial Intelligence (AI) based tools and techniques. The program targets rare diseases and conditions, as well as life-threatening, seriously debilitating, or serious and chronic diseases or conditions.

Mentioned Countries: United States of America, European Union, Associated Countries

Project Stage: The project stage can be at any point of the pre- or post-market stage, including the development stage, with the overall purpose to generate data in support of CE marking under the Regulations on medical devices (MDR) or in vitro diagnostic medical devices (IVDR).

Funding Amount: The indicative funding range is between EUR 6,000,000 to EUR 8,000,000 per grant for most topics, with one topic (HORIZON-HLTH-2025-03-DISEASE-02-two-stage) having a budget of EUR 50,000,000 and an indicative number of grants of 7. Another topic (HORIZON-HLTH-2025-03-ENVHLTH-01-two-stage) has an indicative funding range between EUR 6,000,000 to EUR 7,000,000 and an indicative number of grants of 6.

Application Type: The application type is a two-stage open call.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves two stages. In the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the 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. For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic is provided, allowing for an estimation of the competition level.

Co-funding Requirement: The need for co-funding is not explicitly mentioned; however, eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme.

Summary: This Horizon Europe call aims to bolster the EU health industry by funding multinational clinical studies of orphan and breakthrough medical devices, including those incorporating digital and AI technologies. The call encourages participation from SMEs and requires consortia to conduct studies in at least two EU or associated countries. Projects should focus on generating clinical data to support CE marking, involve patients and healthcare professionals in study design, and develop regulatory strategies. Funding is provided as a lump sum, and the application process involves a two-stage evaluation. The call is part of a blind evaluation pilot, and applicants must adhere to specific guidelines regarding proposal content and format. The overall goal is to improve patient access to innovative medical devices, enhance the market position of EU companies, and advance knowledge in conducting multinational clinical studies. The call is structured around several specific topics, each with its own budget and indicative number of grants, all contributing to the broader objective of maintaining a competitive and sustainable EU health industry. The indicative number of grants for each topic varies between 5 and 7.