Published on June 25, 2024, the MDCG 2024-10 guidance on the clinical evaluation of orphan devices clarifies the criteria for defining whether a device can be considered as such in accordance with Regulation (EU) 2017/745 (MDR). It provides directions to manufacturers and notified bodies (NB) for applying the clinical evidence requirements imposed by the regulation, and to overcome some of the challenges that delay patient access to these devices.   

This document specifies that relevant expert panels may be requested by manufacturers and NBs to provide advice on the ‘orphan devices’ status and on the clinical data needed for the clinical evaluation.



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