GENERAL

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 Regulation (EU) 2017/745, 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 have already been noted in the past. Activities performed by JAZMP within the vigilance system involve primarily the collecting and evaluation of serious 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 incident’ with medical device means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.

‘A Serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:

  • the death of a patient, user or other person;
  • the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
  • a serious public health threat.

Participants in the vigilance system regarding serious incidents involving a medical device occurring in the territory of the Republic of Slovenia, must report to JAZMP.

Availability of JAZMP for urgent vigilance cases:

PROCEDURE FOR PARTICIPANTS IN THE MEDICAL DEVICE VIGILANCE SYSTEM

FORMS

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