Medical device CE marking

MDCG 2021-12 FAQ on EMDN


On June 4, the MDCG issued MDCG 2021-12 on FAQ on the European Medical Device Nomenclature (EMDN).

Six questions answered regarding EMDN:
1. What is the European Medical Device Nomenclature (EMDN)?
2. How was the EMDN created?
3. What are the key principles of EMDN?
4. How do I gain access to the EMDN?
5. How is the EMDN structured?
6. Which level of the EMDN should I use to assign a term to my device?

The document can be downloaded in our library

The same document can also be found in our library in a different format / layout, published by the European Commission on June 15, 2021.

Source: European Commission