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Call for proposals for a program on orphan medical devices, in particular targeting paediatric patients (HS-g-23-65)
EU4Health programme 2021-2027
Estimated EU contribution per project
Link to the call
Link to the submission
This action is part of the Health Systems and Healthcare Workforce related to the implementation of Regulations on medical devices and in vitro diagnostic medical devices.
This action aims to support non-profit organisations or consortia that provide a platform for academic bodies, scientific societies, developer of devices, in particular SMEs, and NGOs with a specific interest in innovative paediatric devices to help foster and guide the development of orphan devices, for paediatric patients, in particular in areas of unmet medical needs. It takes inspiration from the Paediatric Device Consortia Grants Program of the US Food and Drugs Administration (FDA).
Expected effects and impacts
This program is intended to promote in the EU the development of innovative orphan devices especially for paediatric patients, with a particular focus on devices responding to unmet medical needs.
The activities may include, among other things, 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:
a) encouraging innovation and connecting relevant players (e.g. academia, scientific societies, users) with orphan device ideas with potential manufacturers;
b) mentoring and managing orphan device projects through the development process, including product identification, prototype design, device development, and marketing;
c) connecting developers of innovative devices and physicians to existing financing resources;
d) assessing the scientific and medical merit of proposed orphan device projects;
e) providing assistance and advice as needed on business development, personnel training, prototype development, and post-marketing needs; and
f) providing regulatory consultation to device developers in support of achieving CE marking for the orphan device.
A successful entity, which could also be a consortium formed by the eligible entities, can support orphan medical device advancement through all stages of development: concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization.
To accomplish this work, a successful entity should unite natural persons, associations, or institutions to provide the following capabilities: knowledge of the clinical needs for orphan devices, business planning, regulatory advising, intellectual property protections and other legal expertise, as well as scientific, engineering, pre-clinical, and clinical capabilities.
A successful entity which could also be a consortium formed by the eligible entities can support orphan medical device advancement through all stages of development: concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization.
To accomplish this work, a successful entity should unite natural persons, association, or institutions to provide the following capabilities: knowledge of the clinical needs for orphan devices, business planning, regulatory advising, intellectual property protections and other legal expertise, as well as scientific, engineering, pre-clinical, and clinical capabilities.
Regions / countries for funding
Moldova (Moldova), Island (Ísland), Norway (Norge), Ukraine (Україна)
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)
Applications may be either by a single applicant or a consortium (no minimum requirement).
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
- eligible non-EU countries: listed EEA countries and countries associated to the EU4Health Programme or countries which are in ongoing negotiations for an association agreement and where the agreement enters into force before grant signature (list of participating countries)
Other entities may participate in other consortium roles, such as associated partners, subcontractors, third parties giving in-kind contributions, etc.
Natural persons — 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 — International organisations are eligible. The rules on eligible countries do not apply to them.
Entities without legal personality — 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 — 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.
other eligibility criteria
Priority will be given to projects that support the development of paediatric devices, in particular paediatric cardiac devices.
Additional priority will be given to projects that support the development of several orphan devices.
Specific mandatory deliverables and/or milestones
- Report on the advancement of the devices supported for further development and expected future milestones until market access.
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)
between 12 and 36 months
The costs will be reimbursed at the funding rate fixed in the Grant Agreement (60%). You can apply for a higher project funding rate (80%) if your project is of ‘exceptional utility’, i.e. concerns:
- actions where at least 30 % of the budget is allocated to Member States whose GNI per inhabitant is less than 90% of the EU average or
- actions with bodies from at least 14 Member States and where at least four are from Member States whose GNI per inhabitant is less than 90% of the EU average.
Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System (accessible via the Topic page in the Search Funding & Tenders section). Paper submissions are NOT possible. Proposals (including annexes and supporting documents) must be submitted using the forms provided inside the Submission System.
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 (to be downloaded from the Portal Submission System, completed and then assembled and re-uploaded)
- mandatory annexes and supporting documents (templates available 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)