With an increasing number of medical devices in use or on the market, there are also incidents associated with them. Incidents with medical devices are managed in medical device vigilance system, following the Guidelines on a Medical Devices Vigilance System, which for the territory of the Republic of Slovenia are incorporated into the Medical Devices Act (Official Gazette of the Republic of Slovenia, No 98/09) and the Rules on the vigilance of medical devices (Official Gazette of the Republic of Slovenia, No 61/10). The medical devices vigilance system has been established in order to protect public health, the health and safety of patients and other users of medical devices by introducing safety corrective measures and reducing the possibility of recurrence of a medical device-related incidents that has already been noted in the past. Activities performed by JAZMP within the vigilance system involve primarily the collecting and evaluation of incident reports in cooperation with the manufacturer of medical devices or manufacturer’s authorised representative, follow up of the manufacturer or his authorised representative in the investigation of the incident, implementation of any further measures necessary to complement the measures applied by the manufacturer or his representative, and cooperation in the international system of medical device vigilance.
The term incident with a medical devices means any malfunction or deterioration in the characteristics or performance of a medical device from the medical or technical aspect, including any non-conformity in labelling or instructions for use which may cause or have already caused death or serious deterioration in the state of health of the patient, user or other persons.
The criteria for determining an incident with a medical device:
- an event actually occurred,
- a medical device is suspected to be a contributory cause of the incident, and
- the event led or might have led to death of the patient, user or other person, or to serious deterioration in the state of health of the patient, user or other person.
Participants in the vigilance system regarding incidents involving a medical device occurring in the territory of the Republic of Slovenia, must report to JAZMP when all three of the above stated criteria for determining the incident are fulfilled.
Availability of JAZMP for urgent vigilance cases:
- Telephone/Fax numbers: see 24-hours availability
- Email contact:
PROCEDURE FOR PARTICIPANTS IN THE MEDICAL DEVICE VIGILANCE SYSTEM
- MedPri-VIG-obr01 Notification on complications incident involving a medical device
- MEdPri-VIG-obr02 – NEW – Manufacturer Incident Report (MIR 7.2.1) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) (Helptext)
- MedPri-VIG-obr03 Field Safety Corrective Report form
- MedPri-VIG-obr04 Field Safety Notice template