New Modifications on Vigilance Terms from MDCG

MDCG has made minor modifications to the MDCG 2023-3 guidance, “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746.”

Modifications on Vigilance Terms and Concepts from MDCG

The modifications implemented include:

1. Question 1, Footnote 8: Amended to align with Regulation (EU) 2024/1860, which updates Regulations (EU) 2017/745 and (EU) 2017/746. This includes provisions for the gradual roll-out of EUDAMED, obligations to inform in case of supply interruptions or discontinuations, and transitional provisions for certain in vitro diagnostic medical devices.
2. Question 21: The reference to ‘Eudamed vigilance (VGL) module’ has been updated to ‘Eudamed Post market surveillance and Vigilance module (VGL module).’
3. Footnote 34: The phrase ’48 working hours’ has been replaced with ‘allow 48 hours (equivalent to two weekdays).’

The full MDCG guidance document can be found here.

Important EUDAMED Update

With this update, the EUDAMED module for Post-market surveillance and vigilance reporting are now consistently referred to as Post-market surveillance and Vigilance module (VGL Module).

If you have feedback on the MDCG guidance documents or need assistance understanding how these updates may impact your medical device applications, contact us for expert support.

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