EMA – Publication of the Questions and answers on the information session on the pilot for expert panels' advice for orphan medical devices held the 23 September 2024

EMA is initiating a new pilot programme for the expert panels to support manufacturers manufacturing and notified bodies certifying orphan medical devices with the challenges linked to generating clinical evidence for these devices in the premarket phase (see Medical devices). The expert panels can offer advice on the orphan device’s status, the intended clinical development strategies, proposed clinical investigations, or on the data required for the clinical evaluation during an ongoing c...