PROCEDURE FOR PARTICIPANTS IN THE MEDICAL DEVICE VIGILANCE SYSTEM – WHAT TO DO IN CASE OF AN INCIDENT
For healthcare professionals, patients and users of medical devices:
Upon a serious incident or after you have learned of it, you are requested to inform us immediatelly using A report form to report on suspected serious incident with medical device.
For medical device manufacturers or manufacturer’s authorised representatives:
Medical device manufacturers or manufacturer’s authorised representatives must notify JAZMP of any medical device-related serious incident using A Manufacturer Report form for reporting on serious incidents (MIR 7.2.1 Helptext).
The deadlines for reporting adverse events after learning of them are as follows:
- in case of a severe threat to public health, report immediatelly, or within 2 days at the latest;
- in case of death or an unanticipated serious deterioration in a person’s state of health, report immediatelly, or within 10 days at the latest;
- in all other cases report immediatelly after you have established the causal relationship between the serious incident and the device, but not later than 15 days after you became aware of the incident.
For importers and distributors established in the Republic of Slovenia:
Importers and distributors of medical devices must notify JAZMP immediatelly after being informed of the serious incident that has occurred on the territory of the Republic of Slovenia, using a Form to report on a serious incident or serious risk.