---
title: "Second revision to MDCG 2023-3 Guidance document released"
description: "On January 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This second revision of MDCG 2023-3 contains minor clarifications when compared to the first revision."
url: https://qbdgroup.com/en/regulatory-updates/new-revision-to-mdcg-2023-3-guidance-document-released
type: "Regulatory update"
language: en
published: 2025-01-27
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Second revision to MDCG 2023-3 Guidance document released\", https://qbdgroup.com/en/regulatory-updates/new-revision-to-mdcg-2023-3-guidance-document-released"
---
# Second revision to MDCG 2023-3 Guidance document released
> On January 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This second revision of MDCG 2023-3 contains minor clarifications when compared to the first revision.

[MDCG 2023-3 Rev. 2: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746.](https://health.ec.europa.eu/document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf)

### What is updated in MDCG 2023-3 Rev. 2:

In explaining the difference between incidents and serious incidents, the reporting obligations of manufacturers are updated to align with the current gradual roll-out of Eudamed.

Reference to ‘Eudamed vigilance module’ is corrected to ‘Eudamed Post-market surveillance and Vigilance module’.

The review and commenting period for a competent authority upon receiving a draft Field Safety Notice is clarified to be 2 weekdays.

### What does it mean to you?

**MDCG 2023-3 Rev.2** is important for **all MD and IVD manufacturers that place products on the EU market:** they have to comply with the vigilance obligations from MDR respectively IVDR. Establishing a good understanding of vigilance terms and concepts is important to effectively implement the vigilance requirements under these Regulations.

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Source: https://qbdgroup.com/en/regulatory-updates/new-revision-to-mdcg-2023-3-guidance-document-released — © QbD Group. Quote freely with attribution and a link back.