The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 – In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users.
This document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.