Changing CE Mark on Documentation

RCW

Quite Involved in Discussions
#1
A customer is changing the CE mark / reference number on the documentation included with the product. I am asking him to revise his documentation (change revision level) to reflect the new CE mark. He wants me to issue him a nonconformance document where upon he will return it with a use-as-is status.
The plan is to put a label on the documentation with the new CE number BUT not to revise the part number with a label or any other method.

This is really bothering me as per ISO13485:
The organization shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met.

Is there a regulatory requirement being violated here?
 
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medwise

Involved In Discussions
#2
Does your customer have a "Document Control" policy and procedure in place? What does it say?

IMO label must be document controlled and any changes made must be version tracked to meet the requirements of ISO 13485:2003 clauses 7.3.2, 7.3.3, 7.5.1, and 4.2.4.

ISO 13485 is generally used to demonstrate compliance with Essential Requirements. If requirements of ISO 13485 are not met then there are chances that Essential Requirements are not fulfilled (until otherwise a manufacturer can demostrate an alternatively developed QMS which is as good as QMS based on ISO 13485). Therefore, to answer your question - I see it as a regulatory violation!
 
Last edited:

pkost

Trusted Information Resource
#3
I'm confused...

Why is your customer changing the CE mark and documentation, what are the changes? Are they doing this with your agreement? Do you have control over their activities?

Is your customer selling the product on? Do they take any responsibility as manufacturer on pack?
 
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