Vigilance

SIFI Group has a Vigilance system that allows us to take full responsibility for our medical and non-medical products, both marketed or in clinical development and to take appropriate actions, if and when needed, in order to evaluate and update all information regarding the benefit-risk of our products.

The SIFI Group Vigilance system includes:

Pharmacovigilance
MaterioVigilance

 

How do I report an adverse drug event, or an incident related to the use of a medical device?

1. You can contact the ANSM, which monitors health products by various means.
The ANSM has implemented systems to collect signals and alerts from patients, patient associations, health professionals and manufacturers.
For more information, visit their website.

2. Or, you can directly contact our vigilance service SIFI FRANCE.
Phone: +33. (0)1.41.12.18.68
Email: vigilance.fr@sifigroup.com

3. You can also contact our vigilance service by filling out the form below.

 
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Pharmacovigilance allows:

•    learning more about drugs, properly informing the doctors who prescribe them and protecting patients who take them;
•    to ensure that the drugs available on the market may have a favorable benefit-risk for the population.

What is an adverse reaction?

A response to a medicinal product which is noxious and unintended, including:
• uses within the terms of the marketing authorization.
• uses outside the terms of the marketing authorization: off-label use, overdose, misuse, abuse and medication errors, as well as associated with exposure for professional reasons.

Whenever an adverse reaction or side effect occurs during therapy, it should be promptly reported to a doctor or pharmacist.

MaterioVigilance of medical devices

The MaterioVigilance for medical devices is a System for the collection of alerts that occur with the use of a medical device aimed at improving the health and safety of users, reducing the probability of occurrence of the same type of Incident.
 
What is a Medical device?

An instrument, a device, a system, a substance or other, used alone or in combination, including the software necessary for the proper functioning, intended by the manufacturer to be used on people for the purpose of:
•    diagnosis, prevention, monitoring, treatment or alleviation of a disease,
•    diagnosis, monitoring, treatment, alleviation or compensation of an injury or handicap,
•    investigation, replacement or modification of the anatomy or of a physiological process
•    intervention on conception,
provided they do not perform its principal action in or on the human body, to which it is intended, by pharmacological immunological means, nor through metabolic process, but whose function may be assisted by such means.
 
What is an Incident?

a) any malfunction or change in the characteristics and performance of a medical device, as well as any inadequacy in the labelling or the instructions of use that may be or have been the cause of death or serious deterioration of the health conditions of a patient or a user;
b) any technical or medical reason in relation to the characteristics or performances of a medical device that, for the reasons referred to in point (a), leads to the systematic recall of devices of the same type by the manufacturer.
 
MaterioVigilance of Surgical devices

In accordance with the provisions of the Medical Device Vigilance Guideline (MEDDEV 2.12.1), SIFI S.p.A. actively runs a post-marketing monitoring system on its products. This activity is useful to verify customer's perceptions on the quality and performance characteristics of devices and ensures, through continuous monitoring, product safety.
 

 
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