| 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.