MDCG 2023-3 Rev. 2: Updates for Vigilance Terminology

Effective post-market surveillance, as described in Article83(4) MDR and 78(4) IVDR, is critical for device safety.

The Medical Device Coordination Group (MDCG) has released Revision 2 of MDCG 2023-3, a crucial document for understanding vigilance terms and concepts under the Medical Device Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746. This revision, dated January 2025, incorporates several key updates to further harmonize the application of vigilance requirements.

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The changes primarily focus on alignment with the IVDR, clarifying definitions, and integrating recent regulatory adjustments, including developments concerning the phased rollout of Eudamed.

Key changes include:

Eudamed Alignment: Footnote 8 has been amended to align with Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out ofEudamed.

Eudamed Terminology: Reference to ‘Eudamed vigilance (VGL) module’ is amended to ‘Eudamed Post-market surveillance and Vigilance module (VGL module)’.

FSN Drafting Time: Footnote 34 Mention of ’48 working hours’ replaced with ‘allow 48 hours (equivalent to two weekdays)’.

These revisions are essential for manufacturers, notified bodies, competent authorities, and other stakeholders to ensure continued compliance with the MDR and IVDR vigilance reporting requirements. It reinforces the importance of a shared understanding of vigilance terminology for the proper management andr eporting of incidents and serious incidents as defined in Article 2(64)MDR/Article 2(67) IVDR.

The MDCG states in their document that it is non-legally binding and that only the Court of Justice of the European Union can give binding interpretations of Union law. Therefore, this summary will serve as informational guidance only. As well,this document needs to be read in conjunction with the Regulations, relevant standards, and other MDCG guidance documents.

The document itself can be found here: https:// health. ec.europa.eu/ document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf (delete blanks for link to the site)

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A robust vigilance system is crucial for identifying and reporting products that pose a serious risk, ensuring patient safety, maintaining compliance with regulatory requirements according to MDR and IVDR, and mitigating these risks.

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