Call for proposals for a programme on orphan medical devices, in particular targeting paediatric patients

The upcoming EU4Health program call EU4H-2026-SANTE-PJ-07 focuses on proposals for orphan medical devices, especially for pediatric patients. Set to open on September 23, 2025, and close on January 6, 2026, this grant opportunity has a budget of €1,200,000 and operates under the EU4H Project Grants framework. The initiative targets non-profit organizations and consortia that provide support across the medical device innovation ecosystem. Eligible activities include mapping unmet medical needs, facilitating development, testing, production, and regulatory compliance for orphan devices. The emphasis on pediatric applications highlights the need for innovative solutions in this area, given the unique challenges faced by children in need of medical attention. The single-stage application process requires complete proposals by the deadline. The funding aims to bolster the development of orphan devices by supporting various stages from design to commercialization, promoting a collaborative, multifaceted approach to medical device innovation.

This EU funding opportunity is part of the EU4Health Programme (EU4H) and is specifically a call for EU4H SANTE Action Grants 2025 (EU4H-2026-SANTE-PJ). The type of action is EU4H-PJG, which stands for EU4H Project Grants. The Model Grant Agreement (MGA) type is EU4H Action Grant Budget-Based [EU4H-AG]. This is a forthcoming call with a single-stage deadline model. The planned opening date is 23 September 2025, and the deadline for submission is 06 January 2026 at 17:00:00 Brussels time.

The expected impact of this action is to promote the development of innovative orphan devices, especially for paediatric patients, with a particular focus on devices responding to unmet medical needs. The objective is to support innovation in the field of medical devices by supporting non-profit organisations or consortia. These organisations should provide a platform for academic bodies, scientific societies, developers of devices (particularly SMEs), and NGOs with a specific interest in innovative medical devices. The aim is to help foster and guide the development of orphan devices, particularly in areas of unmet medical needs and for paediatric patients.

The scope of the funding covers a wide range of activities that support the development, design, production, and distribution of orphan devices. This includes intellectual property advising, prototyping, engineering, laboratory and animal testing, grant-writing, and clinical investigation design.

Eligible entities should facilitate the development, production, and distribution of orphan devices, particularly for paediatric patients, by undertaking the following activities:

a) Mapping unmet medical needs that could be addressed by orphan devices.
b) Encouraging innovation and connecting relevant players (e.g., academia, scientific societies, users) with orphan device ideas with potential manufacturers.
c) Mentoring and managing orphan device projects through the development process, including product identification, prototype design, device development, and marketing.
d) Connecting developers of innovative devices and physicians to existing financing resources.
e) Assessing the scientific and medical merit of proposed orphan device projects.
f) Gathering and evaluating pre-clinical data to support the safety and/or performance of the orphan device.
g) Providing assistance and advice as needed on business development, personnel training, prototype development, intellectual property protection, and post-marketing needs.
h) Advising about regulatory requirements to device developers in support of achieving CE marking for the orphan devices.
i) Supporting the demonstration of conformity with the relevant requirements laid down in Regulation (EU) 2017/745 or Regulation (EU) 2017/746 with a view to allowing the CE marking of the product building on the guidance MDCG 2024-10 including the scientific advice procedure from the expert panels on medical devices described in section 5 of the call document.

The conditions for this call include:

1. Admissibility Conditions: The proposal page limit and layout are described in section 5 of the call document and Part B of the Application Form available in the Submission System.
2. Eligible Countries: Described in section 6 of the call document.
3. Other Eligible Conditions: Described in section 6 of the call document.
4. Financial and operational capacity and exclusion: Described in section 7 of the call document.
5a. Evaluation and award: Submission and evaluation processes are described in section 8 of the call document and the Online Manual.
5b. Evaluation and award: Award criteria, scoring, and thresholds are described in section 9 of the call document.
5c. Evaluation and award: The indicative timeline for evaluation and grant agreement is described in section 4 of the call document.
6. Legal and financial set-up of the grants: Described in section 10 of the call document.

The call document and annexes include:

Call document
Application form templates:
Standard application form (EU4H) available in the Submission System
Detailed budget table (EU4H)
Model Grant Agreements (MGA):
EU4H MGA
Additional documents:
EU4H Work Programme
EU4H Regulation 2021/522
EU Financial Regulation 2024/2509
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement

The budget overview for the call is as follows:

EU4H-2026-SANTE-PJ-01 - EU4H-PJG EU4H Project Grants: 3,000,000 EUR
EU4H-2026-SANTE-PJ-02 - EU4H-PJG EU4H Project Grants: 7,440,000 EUR
EU4H-2026-SANTE-PJ-03 - EU4H-PJG EU4H Project Grants: 7,440,000 EUR
EU4H-2026-SANTE-PJ-04 - EU4H-PJG EU4H Project Grants: 20,000,000 EUR
EU4H-2026-SANTE-PJ-05 - EU4H-PJG EU4H Project Grants: 2,000,000 EUR
EU4H-2026-SANTE-PJ-06 - EU4H-PJG EU4H Project Grants: 750,000 EUR
EU4H-2026-SANTE-PJ-07 - EU4H-PJG EU4H Project Grants: 1,200,000 EUR
EU4H-2026-SANTE-PJ-08 - EU4H-PJG EU4H Project Grants: 14,386,810 EUR
EU4H-2026-SANTE-PJ-09 - EU4H-PJG EU4H Project Grants: 600,000 EUR

All topics are single-stage, with the opening date planned for 2025-09-23 and the deadline on 2026-01-06.

There are partner search announcements available, where LEARs, Account Administrators, or self-registrants can publish partner requests for open and forthcoming topics after logging into the Portal, as well as any user having an active public Person profile.

The submission system is planned to be opened on the date stated on the topic header.

For support, applicants are advised to read all provisions carefully before preparing their application. For help related to the call, contact HaDEA-HP-CALLS@ec.europa.eu. Additional resources include the Funding & Tenders Portal FAQ for submission of proposals, the IT Helpdesk for technical questions, and the Online Manual for a step-by-step guide through the Portal processes.

In summary, this EU4Health Programme call aims to bolster innovation in medical devices, specifically orphan devices for paediatric patients and those addressing unmet medical needs. It seeks to fund non-profit entities that can act as platforms, connecting various stakeholders like academia, industry, and end-users, to facilitate the entire lifecycle of orphan device development, from initial concept to market distribution. The funding covers a broad spectrum of activities, including design, prototyping, testing, regulatory compliance, and intellectual property management. The call provides a structured framework with specific eligibility criteria, evaluation processes, and a detailed budget allocation across different project grants, all geared towards improving the availability and accessibility of essential medical devices for vulnerable patient populations.

Eligible Applicant Types: The eligible applicant types for this opportunity are non-profit organizations or consortia that provide a platform for academic bodies, scientific societies, developers of devices (in particular SMEs), and NGOs. These entities should have a specific interest in innovative medical devices.

Funding Type: The funding type is a grant, specifically an EU4H Project Grant (EU4H-PJG) under the EU4Health Programme. It is an EU4H Action Grant Budget-Based [EU4H-AG].

Consortium Requirement: Both single applicants and consortia are eligible to apply. The call supports non-profit organizations or consortia.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is not explicitly stated in the provided text. However, given that it is an EU funding opportunity, it is highly likely that applicants from EU member states and potentially associated countries are eligible. Section 2 and 6 of the call document may contain more information on eligible countries.

Target Sector: The target sector is health, specifically focusing on innovation in the field of medical devices, with an emphasis on orphan devices and devices for paediatric patients.

Mentioned Countries: No specific countries are mentioned in the provided text. The opportunity is part of the EU4Health Programme, suggesting that it primarily targets entities within the European Union.

Project Stage: The project stage can vary, as the call supports a wide range of activities from development and design to production and distribution. This includes activities such as prototyping, engineering, laboratory and animal testing, grant-writing, and clinical investigation design. The projects should aim to facilitate the development, production, and distribution of orphan devices, potentially spanning from research and development to demonstration and commercialization.

Funding Amount: The funding amounts vary depending on the specific topic within the call. Based on the provided budget overview, the funding ranges are:
EU4H-2026-SANTE-PJ-01: €3,000,000
EU4H-2026-SANTE-PJ-02: €7,440,000
EU4H-2026-SANTE-PJ-03: €7,440,000
EU4H-2026-SANTE-PJ-04: €20,000,000
EU4H-2026-SANTE-PJ-05: €2,000,000
EU4H-2026-SANTE-PJ-06: €750,000
EU4H-2026-SANTE-PJ-07: €1,200,000
EU4H-2026-SANTE-PJ-08: €14,386,810
EU4H-2026-SANTE-PJ-09: €600,000

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a grant to support their projects.

Application Stages: The application process consists of a single stage.

Success Rates: The success rates are not mentioned in the provided text.

Co-funding Requirement: The text does not explicitly mention a co-funding requirement.

Summary:

This EU4Health Programme call (EU4H SANTE Action Grants 2025) aims to bolster innovation in medical devices, particularly orphan devices addressing unmet medical needs, with a special focus on paediatric patients. The call invites applications from non-profit organizations and consortia comprising academic bodies, scientific societies, device developers (especially SMEs), and NGOs. The grants will support a broad spectrum of activities, including the development, design, production, and distribution of orphan devices. This encompasses intellectual property advising, prototyping, engineering, laboratory and animal testing, grant-writing, and clinical investigation design. Eligible entities are expected to facilitate the orphan device lifecycle, from mapping unmet needs and fostering collaboration to mentoring projects, connecting developers with funding, assessing scientific merit, gathering pre-clinical data, providing business and regulatory advice, and supporting CE marking conformity. The application process is a single-stage submission, with the submission system planned to open on September 23, 2025, and a deadline of January 6, 2026. Funding amounts vary by topic, ranging from €600,000 to €20,000,000. This initiative seeks to promote the development and availability of innovative medical devices for rare conditions, particularly benefiting paediatric populations.