PROCEDURE FOR PARTICIPANTS IN THE MEDICAL DEVICE VIGILANCE SYSTEM – WHAT TO DO IN CASE OF AN INCIDENT
For patients, users, providers of healthcare, pharmacy or other services using medical devices in performing those services:
Upon an incident or after you have learned of it, you are requested to inform us about it no later than within 24 hours using form MedPri-VIG-01.
For medical device manufacturers or manufacturer’s representatives:
Medical device manufacturers or manufacturer’s representatives must notify JAZMP in writing within 24 hours of any medical device related incident, using form MedPri-VIG-obr02 – New Manufacturer incident report 7.2.1 (MIR 7.2.1 Helptext).
In case of any doubt regarding the criteria for reporting incidents, the medical device manufacturer or manufacturer’s authorised representative must notify JAZMP of any medical device-related incident using form MedPri-VIG-obr02. The deadlines for reporting adverse events after learning of them are as follows:
- in case of a severe threat to public health, within 2 days;
- in case of death or an unexpected severe deterioration of health, within 10 days;
- or in other cases within 30 days.
For business entities carrying out wholesale or retail trade in medical devices and importers of medical devices established in the Republic of Slovenia:
Business entities carrying out wholesale or retail trade in medical devices and importers of medical devices must notify JAZMP of any event no later than within 24 hours of their being informed of the event, using form MedPri-VIG-obr02.