In this video, the following question is briefly answered:
“When does vigilance reporting apply and who is responsible for this process?”
In this “trilogy” we talk about the safety reporting of different legal frameworks in The Netherlands.
The last 2 weeks we talked about safety reporting for clinical investigations that are conducted for conformity purposes and other clinical investigations.
Today, we are going to briefly answer the question:
When does vigilance reporting apply and who is responsible for this process?
When it comes to clinical investigations with medical devices that bear the CE marking and the investigation is conducted within the scope of the intended use with invasive or burdensome procedures added to the conduct of the investigation, this so-called post-market clinical follow-up falls under art. 74.1.
In addition to the safety reporting of procedure related events of these PMCFs, as mentioned in part 1 of this trilogy, vigilance reporting applies when any serious incidents related to the device occurred, including field safety corrective actions.
This vigilance reporting is the responsibility of the manufacturer.