MDCG have update Guidance MDCG 2023-3 Q&A on vigilance terms and concepts to Revision 2.
There have been several editorial changes made to footnote 8 (adapted to gradual roll-out of Eudamed), Q21 (changed reference to ‘Eudamed Postmarket surveillance and Vigilance module (VGL module)’) and Footnote 34 (timeline for FSN clarified).
You can find the updated document via the link: https://health.ec.europa.eu/document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf .
