Medical device CE marking

MDCG 2021-12 FAQ on EMDN – Rev.1

2025-01

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

In January 2025 revision 1 became available with restructuring of questions into clear categories
and addition of Questions 7 – 24

First 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

Source: European Commission