Vigilance system is an information exchange and management system based on user reporting reaction. For this reason, users are urged to report to the manufacturer any serious adverse event related to a medical device.
At the same time, users can report the incidents to the competent authority by completing and sending the form “Medical Device Adverse Incident User Report Form”.

Any personal information contained on this form is considered confidential and is accessible only by the personnel of the Competent Medical Equipment Authority.

It is noted that natural or legal persons may claim damages for defects caused by a defective medical device in accordance with applicable Union and national law (Directive 85/374 / EEC).