Call for proposals for a program on orphan medical devices, in particular targeting paediatric patients (HS-g-23-65)
Programme Category
Programme Name
Programme Description
The Programme aims to improve and promote health in the Union to reduce the burden of communicable and non-communicable diseases by:
- protecting people from serious cross-border health threats
- improving the availability, accessibility and affordability of medicines, medical devices and other crisis-related products in the EU
- strengthening national health systems
Identifier Code
Call
Summary
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).
Detailed Call Description
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.
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:
- 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;
- providing assistance and advice as needed on business development, personnel training, prototype development, and post-marketing needs; and
- 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.
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
The costs will be reimbursed at the funding rate fixed in the Grant Agreement (60%). Your organisation can apply for a higher project funding rate (80%) if your project is of “exceptional utility”. Actions shall be considered to have exceptional utility where at least 30% of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90% of the Union average; or the project concerns actions with bodies from at least 14 Member States and where at least 4 are from Member States whose GNI per inhabitant is less than 90% of the EU average.
Thematic Categories
- Health
- Other Thematic Category
- Research, Technological Development and Innovation
- Small-Medium Enterprises and Competitiveness
Eligibility for Participation
- Educational Institutions
- NGOs
- Non Profit Organisations
- Other Beneficiaries
- Private Bodies
- Researchers/Research Centers/Institutions
- Small and Medium Enterprises (SMEs)
Eligibility For Participation Notes
Applications will only be considered eligible if their content corresponds wholly (or at least in part) to the topic description for which it is submitted.
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)
Type of applicants targeted: scientific societies, academia or research institutions and NGOs, possibly also including SMEs with a particular interest and expertise in the area of the action i.e. development of medical devices, especially for children and/or unmet medical needs
Specific eligibility criteria applicable to the consortium composition: Applications may be either by a single applicant or a consortium (no minimum requirement)
Call Opening Date
Call Closing Date
National Contact Point(s)
Ministry of Health, Department of European Affairs
Ms MAKRIGIORGI Elena
emakrigiorgi@moh.gov.cy
EU Contact Point
Stefan DE KEERSMAECKER
+32 2 298 46 80
stefan.de-keersmaecker@ec.europa.eu
Darragh CASSIDY
+32 2 298 39 78