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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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:
- How to deal with nonconformities in an ISO 9001 certification audit- https://advisera.com/9001academy/blog/2015/06/09/how-to-deal-with-nonconformities-in-an-iso-9001-certification-audit/
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Dec 16, 2020