Hi
I am looking over what to report to the competent authority for adverse incidents. I am happy that with the information supplied by Advisera my quality manual covers that.
I am curious about a situation though, we purchase a class 1 device from the manufacturer and sell it. Our customer has purchased 10 this last year and 3 have broken. I suspect it is their handling of the device. They believe this should be reported to the competent authority (MHRA in our case) as a product defect.
Does anyone have advice on this? if it was a IIa or b I would possibly understand, but I am unsure here. No adverse incident has occured from this, no one has been harmed.
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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
It sounds to me as if this is only a customer complaint. Since there was no harm to the patient, user, or public, it is not necessary to report it to the competent authority.
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Aug 14, 2023