REPORTING BY healthcare professionals, users and patients
Any suspected serious incident is to be notified promptly to JAZMP by using the form for reporting:
- ONLINE REPORTING FORM (after completion the data will be automatically forwarded to JAZMP)
DO NOT DISCARD the medical device that caused the incident; RETURN it to the manufacturer for analysis.
In accordance with Article 30 of ZMedPri-1 (Official Gazette of the Republic of Slovenia no. 40/2025), healthcare professionals shall report any suspected serious incidents involving medical devices to JAZMP as soon as possible, or at the latest within 48 hours of discovering or becoming aware of the serious incident. Based on the consent of the healthcare professional, JAZMP may send the economic operator the name and contact details of the healthcare professional as stated in the report for the purpose of the investigation.
For the purpose of investigating a serious incident, the healthcare institution shall allow the economic operator access to the device involved in the suspected serious incident and which it has reported. If this is not possible, the healthcare institution shall provide a sample of the same device.
REPORTING BY 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:
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(In case the file cannot be opened, please save it first. The following instructions with explanations may help you completing the form.)
- NEW: Updated incident reporting form – MIR 7.3.1 (published on 5 May 2025 on the European Commission’s website).
(In case the file cannot be opened, please save it first. The following instructions with explanations may help you completing the form.)
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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.
Please send the completed form .pdf and .xml format by email to .
REPORTING BY Medical device importers and distributors
Importers and distributors of medical devices must report a serious incident to the manufacturer and the manufacturer’s authorised representative (in case of a distributor, also to the importer) immediately after having learned of it.
Importers and distributors of medical devices must report to JAZMP, when the device has been identified as posing a serious risk in relation to the serious incident that has occurred. In this case, please inform JAZMP on the following form:
