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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.
