MDCG 2021-12 Rev2: EMDN FAQ update

The MDCG has published Revision 2 of the MDCG 2021-12 guidance, dedicated to the FAQ on the European Medical Device Nomenclature (EMDN).

This revision ensures continuity of the regulatory framework, with no substantive changes, and provides targeted clarifications on three key points:

Clarification on the use of the code extensions “99 – Other(s)” and “90 – Various”

More detailed guidance on the proper consultation of the EMDN

Clarification regarding Category X, related to Annex XVI products under the MDR

A useful update to further secure EMDN code assignment, particularly in the context of UDI/EUDAMED registrations, technical documentation and certification activities.

DOWNLOAD THE MDCG 2021-12 REV2 EMDN FAQ