---
title: "New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)"
description: "The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – MDR and Article 23 of Regulation (EU) 2017/746 - IVDR, will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users (MDCG 2024-02)."
url: https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-on-updating-the-european-medical-device-nomenclature-emdn
type: "Regulatory update"
language: en
published: 2024-03-15
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)\", https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-on-updating-the-european-medical-device-nomenclature-emdn"
---
# New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)
> The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – MDR and Article 23 of Regulation (EU) 2017/746 - IVDR, will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users (MDCG 2024-02).

Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

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##### The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – MDR and Article 23 of Regulation (EU) 2017/746 - IVDR, will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users (MDCG 2024-02).

[MDCG 2024-02 – Procedures for the updates of the European Medical Device Nomenclature.](https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf)

This document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.

### Annual review

- Actor involved are the MDCG Nomenclature working group, the EMDN Technical team or EMDN-TT and the users
- The procedure for the annual revision is in 4 phases
  - Phase I: collection of requests (January)
  - Phase II: Evaluation of requests and analysis of practical use (February-July)
  - Phase III: Validation and endorsement (August -October)
  - Phase IV: MDCG endorsement and publication (November -December)

### Pilot procedure for ad-hoc updates

- Only requests submitted by the competent authority and the notified bodies qualify under the ad-hoc procedure
- Only new codes requests may be submitted

## What Does This Mean To You?

MDCG 2024-02 provides insights in the process how the EMDN remains up to date and how ad-hoc requests can be done.

[![Regulatory Affairs](https://no-cache.hubspot.com/cta/default/7030766/interactive-182180411307.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLL0xJMCp6TG8Ga%2BzhCS61Y9cOW0YVnFHOVUNRCuM1ZfnztnxCaVc4sTBQbgxbOLUEHJ6joMNE4h29XWaOSvRjY%2FloZ1W5rADV0va8oO6Kzlhvx%2Ba5nGGFLMpxpvoiC%2BVJDka5Hi8u9q4z0ppQngCfTRzVpBG7UkoDYwLivJ74U6p1A15ESbxHWXK06qpW%2B4pqV1e60JiVco&webInteractiveContentId=182180411307&portalId=7030766)
---
Source: https://qbdgroup.com/en/regulatory-updates/new-mdcg-guidance-on-updating-the-european-medical-device-nomenclature-emdn — © QbD Group. Quote freely with attribution and a link back.