Your agreement with the product's notified body may contain details about the expected notification method.
If the change does not seem significant, you can write a rationale following the flowcharts in the guidance and explaining why/how you have reached that conclusion.
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD:
https://ec.europa.eu/docsroom/documents/40301------------------------------
Anne LeBlanc
United States
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Original Message:
Sent: 07-Aug-2022 17:12
From: Shikha Malik
Subject: EU MDD
Hi,
I have a question related to labeling update. The IFU is going to be revised to remove a warning and include information that would say the device is MR Safe. Although, this is a retrospective update to the labeling but I suppose this would trigger a MDD change notification to a class III implantable device containing animal tissue. What do you think?
If you agree that it would trigger a MDD notification, what should be the documentation requirement apart from the redlined/clean copy of the labeling.
Please let me know your thoughts.
Thanks!
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Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
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