Reporting incidents involving medical devices
The Italian Ministry of Health monitors all incidents involving medical devices, active implantable medical devices, and in vitro diagnostic medical devices.
Public and private healthcare professionals who, in the course of their activities, detect any alteration in the characteristics or performance of a device, or any inadequacy in the instructions for use that may have caused or could cause the death or serious deterioration of the health of a patient or operator, are required to immediately report the incident to the Ministry of Health.
The objective of the vigilance system is to enhance the protection of patients’ health and safety, as well as that of users and others, by reducing the likelihood of recurrence of harmful incidents.
The data collected through this process allow, where necessary, the implementation of corrective actions by the manufacturer or restrictive measures by the Ministry of Health to safeguard public health.
Who to contact in case of a suspected adverse reaction report
In the event of a serious incident, even if only suspected, public or private healthcare professionals are required to notify:
- the Ministry of Health, in accordance with the Circular dated 29 November 2022;
- the manufacturer or its authorized representative, including through the medical device distributor.
In the event of a non-serious incident, public or private healthcare professionals:
- must report it to the manufacturer or its authorized representative, also through the distributor;
- may report it to the Ministry of Health, following the procedures outlined in the Circular of 29 November 2022.
How to report a suspected adverse reaction
- Specific reporting forms are available on the website of the Ministry of Health.
- For communications directed to Campoverde, as the distributor, you may write to the email address medicinanucleare@campoverde.it, using the following subject line: “Medical Devices Vigilance.”
Confindustria Medical Devices Code of Ethics and Transparency Obligations
The Code of Ethics of Confindustria Dispositivi Medici requires member companies to publish each year on their website the transfers of value made directly to healthcare professionals, healthcare organizations, and third parties. These include, among others, donations, scholarships, sponsorship agreements for the organization of events, travel and hospitality, as well as fees for services, consultancy, research, and development.
The disclosure of Transfers of Value (ToV) provided by the industry to Healthcare Professionals (HCPs), Healthcare Organizations (HCOs), and Third Parties (TPIs) represents an important step in the broader effort to ensure greater transparency regarding how the industry interacts with HCOs and HCPs.
For information about the regulations introduced by the Code of Ethics adopted by Confindustria Dispositivi Medici, please visit the website www.confindustriadm.it (section Ethics and Social Commitment / Code of Ethics).
Campoverde Srl, in compliance with the transparency obligations set out in paragraph 4 of the Confindustria Dispositivi Medici Code of Ethics, declares that no direct or indirect transfers of value were made to Healthcare Professionals, Healthcare Organizations, or Third Parties during the year 2024.
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