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Information about undesirable event and conducting investigation

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Guest user Created:   Dec 26, 2022 Last commented:   Dec 27, 2022

Information about undesirable event and conducting investigation

Could you please answer several questions:
1) through which communication channels does the user send a message about an undesirable event to the manufacturer of the medical device?
2) in which cases the competent authority itself conducts an investigation?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Dec 27, 2022
1. through which communication channels does the user send a message about an undesirable event to the manufacturer of the medical device?
By the address that is on the medical device box or in instruction use. Today of course it is mostly used by e-mail. The point is that it should be documented, and not conducted by phone.
2. In which cases the competent authority itself conducts an investigation?"
The competent authority can make an investigation if they receive any information regarding some adverse events or the possibility of a fake medical device.
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