On 27–28 July 2026, Fondazione per la Ricerca Farmacologica Gianni Benzi participated in the OrphaDev4Kids General Assembly, hosted by the Children’s Memorial Health Institute (IPCZD) in Warsaw, Poland.
The meeting brought together all consortium partners to review the project’s progress at the end of its second year, discuss the results achieved so far and define the activities planned for the final phase of the project.
Funded under the EU4Health Programme, OrphaDev4Kids aims to establish the first European platform dedicated to supporting the development of paediatric and orphan medical devices, providing scientific, regulatory, clinical and networking services to researchers, universities, hospitals and SMEs developing innovative solutions to address unmet medical needs.
During the General Assembly, Fondazione Gianni Benzi confirmed its cross-cutting role within the project by contributing to several strategic activities.
Franco Bartoloni (FGB) presented the latest developments of the Matchmaking activities (WP2), showing the progress of the service designed to connect researchers, start-ups, SMEs, investors and other European stakeholders involved in the development of paediatric medical devices.
The presentation highlighted the role of the Access to the Matching Service, the mapping of European matchmaking events primarily targeting start-ups and SMEs, the importance of supporting projects across different Technology Readiness Levels (TRLs), the impact of the MDR/IVDR regulatory framework on funding strategies and medical device development, and the future initiatives aimed at creating new collaboration opportunities between developers, companies and investors.
In addition, the activities carried out by the Foundation in providing ethical and regulatory support to the project’s case studies (WP3, WP4 and WP5) were presented, with particular emphasis on the preparation of the documentation required for future clinical investigations of innovative medical devices.
FGB’s activities include the review of Clinical Investigation Plans (CIPs), Clinical Evaluation Plans (CEPs), study protocols, participant information sheets, informed consent and assent forms, as well as support for the preparation of the documentation required for submission to Ethics Committees.
Particular attention is devoted to the ethical aspects of paediatric clinical research, ensuring that studies are designed in accordance with the highest international standards for the protection of children and other vulnerable participants, in compliance with Regulation (EU) 2017/745 (MDR), EN ISO 14155:2026, the General Data Protection Regulation (GDPR) and the principles of the Declaration of Helsinki.
Through these activities, the Foundation contributes to ensuring that the development of innovative medical devices follows a robust ethical and regulatory pathway, supporting clinical investigations that are scientifically sound, ethically conducted and fully compliant with European requirements, ultimately facilitating access to innovative medical technologies for children affected by rare diseases.
