January 22, 2021
FAQ Friday with Giovanni: answers to your questions about vigilance and incident reporting
In this weeks vlog, Giovanni answers the question: Does it mean that if a certain type of serious incident has been listed in the IFU and assessed in the risk management as acceptable, then it is not to be reported? Even if it has a causal relationship with the device?
Tags
FAQ Friday
MDR 2017/745
Medical Device Regulations
Vigilance
Highlights