PROCEDURE FOR PARTICIPANTS IN THE MEDICAL DEVICE VIGILANCE SYSTEM – STEPS TO TAKE IN THE EVENT OF A SERIOUS INCIDENTS
For healthcare professionals, users and patients:
In the event of a serious incident or upon learning of such an incident, you are requested to promptly report it to the JAZMP using the form for reporting serious incidents:
For medical device manufacturers or their authorised representatives:
The medical device manufacturer or its authorised representative must report a serious incident involving a medical device that has occurred in Slovenia to the JAZMP using the standard European Manufacturer Incident Report Form:
in the event of a serious public health threat, the report must be submitted immediately and no later than 2 days after the manufacturer has learned of the threat.
- in the event of a death or an unanticipated serious deterioration in a person’s state of health, the report must be provided immediately after the manufacturer has established a causal relationship between the device and the serious incident or as soon as they suspect it, and no later than 10 days after the date on which the manufacturer has learned of the serious incident.
- Manufacturers must report any serious incident immediately after having established the causal relationship between such an incident and their device or having determined that such causal relationship is reasonably possible, and no later than 15 days after they have learned of the incident.
In completing the form, you may find useful the provided help text.
Medical device importers and distributors established in the Republic of Slovenia:
Importers and distributors of medical devices must report a serious incident to the JAZMP immediately after having learned of it using the form for reporting serious incidents and perceived serious risks in relation to medical devices:
- Form for reporting serious incidents and perceived serious risks in relation to medical devices – Obr. 685-01