This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the MDR of medical devices and accessories for medical devices that qualify as ‘orphan devices’ (OD) and medical devices and accessories for medical devices that have an orphan indication,
within the meaning of this guidance.

This guidance is relevant to devices across all risk classes as per the classification rules defined in the MDR

This guidance gives particular attention to the clinical evaluation and investigation requirements stated in MDR Chapter VI and Annex XIV for these devices.