Support for manufacturers needing an EMDN Code

· Service Notice

If you are a manufacturer that needs an EMDN Code for registering a product in the EC EUDAMED database, you may find our EMDN Service useful. Get a ‘best match’ suggestion for GMDN codes..

The EMDN Service provides GMDN members with a Manufacturers 'paid-for' account an EMDN Code for each GMDN Code listed in their 'My Terms'.

Log in to access: https://www.gmdnagency.org/Terms/MyTerms

The 'EMDN' button will provide a table with a one-to-one ‘best match’ suggestion. This service does come with a warning that all EMDN Codes should be carefully reviewed before submission to EUDAMED. A full set of EMDN Terms can be downloaded from the European Commission website; https://webgate.ec.europa.eu/dyna2/emdn/.

The choice to use the EMDN, based on the Italian CND system, by the European Commission has been counter to their previous policy of supporting global harmonisation and has been against advice from other members of the IMDRF that have chosen to use the GMDN. The decision also adds complexity and cost of compliance for most manufacturers.

Please note that EMDN terms are drafted more widely than GMDN Terms, so one EMDN term is likely to cover numerous types of medical device, and products falling within different GMDN Terms may be covered by the same EMDN term. The GMDN Agency has no responsibility or liability to you for use of any EMDN term that is identified by this service - it remains your responsibility to ensure you use the most appropriate EMDN term for the relevant medical device. For further assistance please contact the GMDN Agency.