Theme European Medical Device Nomenclature (EMDN) 
Target Audience All the actors 
Products concerned MD, IVD 
Documents mentioned

RDM (UE) 2017/745 – article 26 

RDIV (UE) 2017/746 – article 23 

This guide relates to the : 

  • revision of the European Medical Device Nomenclature (EMDN) 
  • ad-hoc updates to the EMDN requiring accelerated review 

 As a reminder, the EMDN is a free access nomenclature, which facilitates the operation of the Eudamed database. This nomenclature must be used at least by the competent authorities, notified bodies, manufacturers, importers and distributors. 

 As a general rule, applications for revision of the EMDN must be made via the annual procedure. An exception is made for ad-hoc procedures which can only be submitted by competent authorities and notified bodies and which only concern requests for new codes.