Safety reporting of adverse events in performance studies should be made to the JAZMP. This applies to all performance studies conducted in Slovenia which commenced prior to the date of application of the IVDR. Safety reporting of adverse events does not apply to studies conducted in line with Article 70(1) of the IVDR; in such cases vigilance reporting applies according to Articles 82 to 85 and of the implementing acts adopted in accordance with Article 86 of the IVDR.
- any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such causal relationship is reasonably possible;
- any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
- any new findings in relation to any event referred to in points (a) and (b).
Until such a time as the modules of EUDAMED are fully functional, the JAZMP expects sponsors to submit relevant event reports to e-mail address stating the JAZMP reference number assigned to the performance study.
The MDCG has published guidance on the reporting of serious adverse events and device deficiency in clinical investigations under the MDR. In the absence of IVDR specific guidance, sponsors should take into account the principles of this guidance.