Vigilance is a complex of activities aimed to value continuously all the information about the safety of the products, including the suspected adverse reactions, and to ensure, for all the medical devices commercially available, a relation benefit/risk beneficial to the population.
In line with this general definition, the main purposes of Vigilance are:
- prevention of damage caused by adverse reactions in humans
- promoting a safer and more effective use of medical devices, especially giving timely information about their safety to patients, health workers and to the general public.
What is an adverse reaction?
An adverse reaction is a harmful and unwanted reaction following:
- the use of the medical device under normal conditions of use
- medication errors
- improper uses not in compliance with the indications given by the manufacturer, including the overdosage, the improper use of the medical device
- occupational exposure
What to do in case of suspected adverse reaction?
The spontaneous reporting of suspected adverse reactions can be carried out either by the citizens or by health workers, through the sending of specific ministerial forms to the Vigilance's responsables of local healthcare companies, hospitals, nursing homes and Ministry of Health.
For patients and healthcare workers
You'll find the form to fill out online by clicking here: Rapporto di incidente da parte di operatori sanitari al Ministero della Salute.
The files in PDF format generated by the procedure shall be sent to the Ufficio 5 della Direzione generale dei dispositivi medici e del servizio farmaceutico, on this mail address firstname.lastname@example.org
In case you want to make any complaint about one of our products, please fill out the form below or send an e-mail to email@example.com including your Name, Surname and the reference product.