The OrphaDev4kids initiative focuses on improving the development of orphan medical devices (MDs) for paediatric use. Developing these devices is challenging because children have unique physical and medical needs that require devices specifically tailored to them. However, few medical devices are designed with children in mind, and most are adapted from adult versions.
This project aims to provide specialised services to help bring these paediatric devices to the European market. The areas covered include device design, quality control, non-clinical and clinical studies, and regulatory guidance. Additionally, the initiative provides tools to connect innovators with manufacturers and funding. Specialised support will be tailored to three specific paediatric case studies, each representing different needs and developmental stages.
In summary, OrphaDev4kids aims to address critical gaps in paediatric healthcare by making specialised, child-specific medical devices more accessible and ensuring they meet the highest standards.

ROLE OF THE FOUNDATION
The Foundation leads the ethical, regulatory and risk management activities of the project supporting compliance, quality and the effective implementation of project activities and services. In particular, it:
- Monitors the ethical and regulatory compliance of the project activities and services, including authorisations, ethics approvals, informed consent/assent, and GDPR compliance.
- Identifies and addresses ethical and regulatory issues that may arise during the project, providing guidance and support to the project partners, when needed.
- Coordinates risk management activities and identifies the project’s key performance indicators (KPIs) supporting the monitoring of the project’s overall performance;
- Provides ethical and regulatory advice and supports the preparation of documents for clinical studies to test the paediatric Medical Devices developed under the project.
- Informs and updates stakeholders about relevant ethical and regulatory developments, documents and requirements concerning orphan and paediatric medical devices at European and international level, through the management of the Regulatory Database.
Furthermore, the Foundation contributes to the development of tools connecting stakeholders with ideas for orphan and paediatric MDs with potential manufacturers (matching service); collecting and organising researchers’ proposals and needs; facilitating the identification of available funding resources.

FUNDED BY: European Union under the EU4Health Programme (EU4H-2023-PJ-11, Grant Agreement No. 101161377.

DURATION: 1 July 2024 - 30 June 2027

PARTNERS:

European Paediatric Transnational Research Infrastructure (EPTRI), Belgium (coordinator)
- Consorzio per Valutazioni Biologiche e Farmacologiche , Italy (Affiliated Entity)
- Università Degli Studi di Bari Aldo Moro, Italy (Affiliated Entity)
- TEDDY European Network of Excellence for Paediatric Clinical Research, Italy (Affiliated Entity)
- Fondazione per la Ricerca Farmacologica Gianni Benzi – ETS, Italy (Affiliated Entity)
IRCCS - Associazione La Nostra Famiglia 'Istituto Scientifico Eugenio Medea' (MEDEA), Italy
Instytut Pomnik Centrum Zdrowia Dziecka(IPCZD), Poland
Mediziwische Universitat Graz (MUG), Austria