MDCG 2023-3 Rev. 2: Everything you need to know about the new vigilance rules
Important updates for manufacturers and importers: here’s what’s changing!
The Medical Device Coordination Group (MDCG) has published the MDCG 2023-3 Rev. 2, introducing key changes to the vigilance and post-market surveillance of medical devices and IVDs in the EU. This updated guidance provides clearer instructions to improve incident reporting and enhance patient safety.
Key Updates in MDCG 2023-3 Rev. 2
1. Stricter Incident Reporting Timelines
- Critical incidents must now be reported within 48 hours (two working days).
- More precise definitions of “incident” and “serious incident”.
2. New Provisions for EUDAMED
- The “Vigilance Module” has been renamed “Post-Market Surveillance and Vigilance Module“.
- Enhanced integration between vigilance reporting and Field Safety Corrective Actions (FSCA).
3. Clarifications on Corrective and Preventive Actions
- New rules for Field Safety Corrective Actions (FSCA).
- Greater detail on incident evaluation criteria and the relationship with the reported device.
4. Greater Alignment with IVDR Regulations
- Inclusion of specific references to IVDR requirements for in vitro diagnostic devices.
- Updated Q&A section to harmonize regulatory interpretations.
What Does This Mean for Manufacturers and Distributors?
- Ensure compliance with the new reporting timelines to avoid penalties.
- Update internal post-market surveillance processes.
- Integrate EUDAMED’s new provisions into compliance systems.
- Train teams on the latest regulatory updates.
Download the Official Document MDCG 2023-3 Rev. 2 Here
Conclusion
The MDCG 2023-3 Rev. 2 update strengthens the vigilance system and imposes new responsibilities on medical device and in vitro diagnostic manufacturers. Staying informed on these changes is crucial to ensuring compliance and patient safety.
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