Complaints
and Vigilance
Complaints and vigilance reports on medical devices
Medical Devices and Complaints
A technical complaint is defined as a communication declaring deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a device or relating to a service that affects the performance of such devices.
Reporting of medical devices and complaints with D.M.G. devices must be made by writing to the following email address: complaints.dmg@dmgit.com
Medical Devices and Incidents
An incident is any malfunction or alteration of the characteristics or performance of a Medical Device made available on the market, including user error determined by ergonomic characteristics, as well as any inadequacy in the information provided by the manufacturer and any undesirable side effects.
Current regulations indicate the obligations relating to the vigilance on Medical Devices and post-marketing surveillance borne by the Medical Device Manufacturer, including the collection of reports of suspected incidents and side effects.
Reporting of medical devices and incidents with D.M.G. devices must be made by writing to the following email address: farmacovigilanza@dmgit.com
Spontaneous reporting of incidents can be made by both citizens and healthcare professionals, according to the procedures reported on the website: Medical device reporting system
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