Medical Device Regulatory Guide

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MDCG 2021-12 – FAQ on European Medical Device Nomenclature (EMDN) ✅

A key point to consider is devices must be assigned the lowest possible EMDN level.

 The FAQ covers a number of topics, including,

(1)  What is the #EMDN?

(2)  How was it 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 should I use to classify my device?

 

🔗 https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-12_en.pdf