EU Publishes Second Revision of MDCG 2023-3: Key Updates for Manufacturers

1. Alignment with Regulation (EU) 2024/1860
   Footnote 8 has been amended to align with Regulation (EU) 2024/1860, which introduces a gradual roll-out of Eudamed. Additionally, it clarifies the obligation to inform authorities in case of supply interruptions or discontinuations and provides transitional provisions for specific in vitro diagnostic medical devices (IVDs).
2. Terminology Update for Eudamed Vigilance Module
   In Question 21, the reference to ‘Eudamed vigilance (VGL) module’ has been updated to ‘Eudamed Post-market surveillance and Vigilance module (VGL module)’. This change reflects a broader scope of post-market surveillance requirements within Eudamed.
3. Clarification on Reporting Timelines
   Footnote 34 has been revised to replace ‘48 working hours’ with ‘allow 48 hours (equivalent to two weekdays)’. This clarification ensures a consistent interpretation of reporting deadlines.

These updates highlight the ongoing efforts of the European Commission to refine regulatory guidance and improve clarity for manufacturers and stakeholders.

For detailed information, refer to the full guidance document: MDCG 2023-3 Rev.2.

MedNet EC-REP GmbH remains committed to supporting medical device and IVD manufacturers in navigating regulatory changes. For questions regarding Eudamed requirements or compliance, feel free to contact us.