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

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.

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.

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:

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; and

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