Any statistically significant increase in the frequency or severity of “Expected Unwanted Adverse Effects”, which may have a significant effect on the analysis of a serious negative event or benefit-risk and may lead to unacceptable risks in the health and safety of patients, users or others, 92. Reports through the electronic system referred to in the article (electronic system for Post-Marketing Surveillance and Vigilance).
The significant increase is determined by comparing the predictable frequency or severity of such adverse events to the instrument or category or group of devices for a specific period of time, as indicated in the technical documentation and product information. Trend reports apply to all product classes.
