Reporting Adverse Events as Customer Complaints

Talia

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Hello,
We are updating our vigilance SOP and not sure when we are required to report device related, expected Adverse Events (not SAEs) as Customer Complaints in post-marketing trials? Should any AE be reported as complaint if it is device related? We have in our protocols list of expected AEs that do not require reporting to the agencies,. Will this be applicable also for the complaints?

Many thanks,
Talia
 

Aliken

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Hi Talia,

You can check the newly issued MDCG 2023 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023.

Regards,
Daniel
 

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  • mdcg_2023-3_en_0.pdf
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Talia

Involved In Discussions
Thanks Daniel. This is very helpful!
I looks like that if the expected AEs are clearly defined in the IFU and study protocol and as such are not regularly documented as customer complaints, they should not be documented as customer complaints during the clinical trials but only reported to RA for the purpose of trend reporting as part of the PMS activities.
 
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