New MDCG 2024-10: Clinical Evaluation of Orphan Medical Devices
28 June 2024
The MDCG 2024-10 report provides comprehensive guidance on the clinical evaluation of orphan medical devices, designed for rare diseases or conditions affecting fewer than 12,000 people annually in the EU. The device may be intended for the treatment, diagnosis, or prevention of a disease or condition. The document highlights orphan device criteria that must be met apart from offering benefits to the patient (significant clinical benefits, particularly when no satisfactory alternatives exist) in order to be classified as such. The report also provides detailed guidelines for the clinical evaluation and post-market surveillance of orphan medical devices and acknowledges that they often pose challenges due to the small number of patients, limitations in pre-market clinical data and related costs.
Primarily aimed at regulatory authorities, notified bodies, and manufacturers of orphan medical devices, the guidance points out the stakeholders’ tasks and duties including regulatory oversight, certification of devices, monitoring market compliance, ensuring product safety, and managing incident reports. The MDCG 2024-10 report consists of different parts addressing both manufactures and notified bodies and gives specific advice to notified bodies on clinical evaluations and procedural considerations. It also highlights that, given the particular challenges associated with orphan devices, both parties may seek advice from the expert panels on the orphan device status.
