The position paper includes a proposal for a definition of an orphan IVD and for an approach to conformity assessment for this type of devices. The paper was developed taking into account existing guidelines for medical devices i.e. MDCG 2024-10. Team-NB-PositionPaper-Ophan-IVDR-Medical-Devices-V1-20250717 L’article TEAM NB Position Paper on Orphan under the IVDR V1 est apparu en premier sur team-nb.
