MDCG on EMDN & IMDRF (UDI)

The MDCG has endorsed two new documents today! The first FAQ MDCG 2021-12 lays down questions and answers on the EMDN (European Medical Device Nomenclature) and the MDCG 2021-10 provides clarifications on how certain principles and examples from IMDRF N48 Appendixes E-I (UDI Application Guide) apply under the MDR/IVDR, including a comparison table that is non-exhaustive and underlines that the document should be read together with the legal texts of EU MDR & IVDR. Below, an extract of the MDCG comparison table:

 

 

[‘X’ in the table below indicates that this IMDRF principle/terminology is not applicable under either the MDR and/or IVDR]

 

Moving to the FAQ on the EMDN, the MDCG replies to the below 5 questions, where it is also indicated that the second version of EMDN will be released in Q3 2021, in addition to the new terms and descriptions for medical device software.

1. What is the EMND?
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?

You can find both documents in our Library of Documents and its dedicated categories on MDCG, UDI, EUDAMED – under MDR and IVDR!