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CE Marking and Major NCRs

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Guest user Created:   Dec 14, 2020 Last commented:   Dec 16, 2020

CE Marking and Major NCRs

If a CE marked product gets a major NCR from a notified body, does that mean you have to cease selling it until the NCR is addressed?

I am just trying to understand if selling a CE approved product is legal or illegal to sell with known major NCRs against it?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Dec 16, 2020

You are supposed to get this information from your Notify body. Usually, considering major NC it is necessary to send a CAPA plan and prove of solving it within one month.

Here is some general guidance on how to deal with non-conformities:

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Dec 14, 2020

Dec 16, 2020

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