Non-reportable customer complaints and CER

T

Talia

Registered
Hello everyone,
We are updating our clinical evaluation report and not sure if customer complaints classified as non-reportable complaints should be listed in the CER?

Many thanks in advance for any feedback,
Talia
 
shimonv

shimonv

Trusted Information Resource
Hi Talia,
This is the common practice. See section 8.1 the attached MEDDEV guidance.


Shimon
 

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  • 2_7_1_rev4_en.pdf
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T

Talia

Registered
Thanks Shimon! It looks like that not only the complaints should be reported but also the sponsor's evaluation :)
 
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