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.
About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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