EU - MDCG Guidance on Clinical Evaluation for Orphan Medical Devices

The MDCG published MDCG 2024-10 that includes guidelines for the clinical evaluation of orphan devices. The guideline defines orphan devices as indicated for diseases or conditions that present in not more than 12.000 individuals per year within the EU. In addition there have to be either insufficient treatment options or an expected improved benefit by the device under evaluation.