Non-reportable customer complaints and CER

[Talia]

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]

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


Shimon

 

[Talia]

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