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Call key data
Call for proposals for a programme on orphan medical devices, in particular targeting paediatric patients
Funding Program
EU4Health programme 2021-2027
Call number
EU4H-2026-SANTE-PJ-07
deadlines
Opening
23.09.2025
Deadline
06.01.2026 17:00
Funding rate
60%
Call budget
€ 1,200,000.00
Estimated EU contribution per project
between € 300,000.00 and € 400,000.00
Link to the call
Link to the submission
Call content
short description
This action aims to support innovation in the field of medical devices by supporting non-profit organisations or consortia that provide a platform for academic bodies, scientific societies, developers of devices, in particular SMEs, and NGOs with a specific interest in innovative medical devices to help foster and guide the development of orphan devices, in particular in areas of unmet medical needs and paediatric patients.
Call objectives
A wide range of activities can be funded that support, among other things, the development, design, production and distribution or orphan devices, including intellectual property advising, prototyping, engineering, laboratory and animal testing, grant-writing, and clinical investigation design.
The eligible entities should facilitate the development, production, and distribution of orphan devices, in particular for paediatric patients by:
- mapping unmet medical needs that could be addressed by orphan devices;
- encouraging innovation and connecting relevant players (e.g., academia, scientific societies, users) with orphan device ideas with potential manufacturers;
- mentoring and managing orphan device projects through the development process, including product identification, prototype design, device development, and marketing;
- connecting developers of innovative devices and physicians to existing financing resources;
- assessing the scientific and medical merit of proposed orphan device projects;
- 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;
- advising about regulatory requirements to device developers in support of achieving CE marking for the orphan devices; and
- 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.
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Expected effects and impacts
This action is intended to promote the development of innovative orphan devices especially for paediatric patients, with a particular focus on devices responding to unmet medical needs.
Eligibility Criteria
Regions / countries for funding
Moldova (Moldova), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Iceland (Ísland), Montenegro (Црна Гора), Norway (Norge), Ukraine (Україна)
eligible entities
Education and training institution, International organization, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
Mandatory partnership
No
Project Partnership
In order to be eligible, the applicants (beneficiaries and affiliated entities) must:
- be legal entities (public or private bodies)
- be established in one of the eligible countries, i.e.:
- EU Member States (including overseas countries and territories (OCTs))
- listed EEA countries and countries associated to the EU4Health Programme (list of participating countries)
Proposals may be submitted by a single applicant of by consortium.
other eligibility criteria
Specific cases
- Natural persons are NOT eligible (with the exception of self-employed persons, i.e. sole traders, where the company does not have legal personality separate from that of the natural person).
- International organisations are eligible. The rules on eligible countries do not apply to them.
- Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees for the protection of the EU financial interests equivalent to that offered by legal persons
- EU bodies (with the exception of the European Commission Joint Research Centre) can NOT be part of the consortium.
- Associations and interest groupings - entities composed of members may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. Please note that if the action will be implemented by the members, they should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible).
- European Reference Networks (ERNs) — These cover networks between healthcare providers and centres of expertise in the Member States to reinforce healthcare cooperation, in particular in the area of rare diseases, in line with the objectives set out in Article 12 of Directive 2011/24.
- Countries currently negotiating association agreements — Beneficiaries from countries with ongoing negotiations for participation in the programme (see list of participating countries) may participate in the call and can sign grants if the negotiations are concluded before grant signature and if the association covers the call (i.e. is retroactive and covers both the part of the programme and the year when the call was launched).
- EU restrictive measures — Special rules apply for entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU). Such entities are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, subcontractors or recipients of financial support to third parties (if any).
- EU conditionality measures — Special rules apply for entities subject to measures adopted on the basis of EU Regulation 2020/209214. Such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc). Currently such measures are in place for Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain (see Council Implementing Decision (EU) 2022/2506, as of 16 December 2022).
Additional information
Topics
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
project duration
max. 36 months
Additional Information
Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOT possible.
Proposals must be complete and contain all the requested information and all required annexes and supporting documents:
- Application Form Part A — contains administrative information about the participants (future coordinator, beneficiaries and affiliated entities) and the summarised budget for the project (to be filled in directly online)
- Application Form Part B — contains the technical description of the project (template to be downloaded from the Portal Submission System, completed, assembled and re-uploaded)
- mandatory annexes and supporting documents (templates to be downloaded from the Portal Submission System, completed, assembled and re-uploaded):
- detailed budget table/calculator
- CVs (standard) of core project team
- list of previous projects (key projects for the last 4 years) (template available in Part B)
Proposals are limited to maximum 70 pages (Part B).
Financial support to third parties is not allowed.
Call documents
Call Document EU4H-2026-SANTE-PJCall Document EU4H-2026-SANTE-PJ(1036kB)
Contact
Website
HaDEA- EU4 Health
HaDEA-HP-CALLS@ec.europa.eu
Website
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