Safety reporting of adverse events that occur during in vitro diagnostic medical device performance studies should be sent to the JAZMP in accordance with Article 76 of the IVDR and the MDCG 2024-4 Guidance on safety reporting in performance studies. This also applies to performance studies initiated before the date of application 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).
The Medical Device Coordination Group (MDCG) has adopted the MDCG 2024-4 document, which provides further guidance on the reporting of serious adverse events that occur during a clinical investigation, including timelines for reporting to national competent authorities. Until the EUDAMED modules are fully functional, the JAZMP expects sponsors to submit the relevant event reports to , indicating the case number assigned to the performance study application.
Reporting of adverse events does not apply to post-market performance follow-up (PMPF) studies referred to in Article 70(1) of the IVDR. Instead, these studies are subject to the vigilance provisions laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 of the IVDR.
