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Customer complaint - reporting to the authorities

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Guest user Created:   Nov 02, 2022 Last commented:   Nov 02, 2022

Customer complaint - reporting to the authorities

Would it make sense to move the Registry of Reports to the Authorities from section 08 Customer Complaints and Feedback to 15 Non-conformities? Or make a connection in the procedure between the Report to the Authorities and 15 Non-conformities section?

I am still unsure which complaints/non – conformities/ adverse events we should report.

I understand that a complaint can result in non-conformity, and non-conformity could result in some adverse event.

Do I see it correctly?

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Kristina Zvonar Brkić Nov 02, 2022

Yes, you see it correctly. I will paraphrase it: not each complaint will lead to non-conformity and to adverse vents eventually.

In MDR Article 2 Definitions - there is a good definition of what an adverse event is and that should be your guidance:

    1. adverse event’ means any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users, or other persons, in the context of a clinical investigation, whether or not related to the investigational device;

    2. serious adverse event’ means any adverse event that led to any of the following:

    • death;
    • serious deterioration in the health of the subject, that resulted in any of the following: life-threatening illness or injury;
    • permanent impairment of a body structure or a body function,
    • hospitalisation or prolongation of patient hospitalisation,
    • medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
    • chronic disease,
    • fetal distress, fetal death or a congenital physical or mental impairment or birth defect

Our toolkit is tailor-made, so if you think that better logic is to put Registry of Reports to the Authorities from section 08 Customer Complaints and Feedback to 15 Non-conformities, you are absolutely allowed to do that. 

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Nov 02, 2022

Nov 02, 2022