Information about undesirable event and conducting investigation

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.