EU4Health is the EU’s funding programme to deliver on EU health policy and respond to the COVID-19 pandemic.
This call aims to foster and guide the development of orphan devices, for paediatric patients, in particular in areas of unmet medical needs.
Medical devices and In Vitro Diagnostic Medical Devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
Medical devices are subject to Regulation (EU) 2017/745, while IVDs are subject to Regulation (EU) 2017/746.
For the purpose of this action orphan devices32 are medical devices, including in vitro diagnostic medical devices, that benefit a relatively small group of patients in the treatment or diagnosis of a disease or condition.
At EU level, no specific legislation exists regarding the development and/or the market access of orphan devices which are in a large part intended for paediatric patients.
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).
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.
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.
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.
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.:
Expected duration of the project(s) in months: 12-36 months