Trend Reporting
Overview
In addition to individual serious incident reports, manufacturers must report trends — statistically significant increases in the frequency or severity of incidents that are not serious incidents and that have or could have a significant impact on the benefit-risk analysis of the device.
When a Trend Report is Required
A trend report is required when the manufacturer identifies a statistically significant increase (compared to expected rates based on historical data or published literature) in:
- Non-serious incidents related to a specific device
- Incidents that could have a significant impact on the benefit-risk balance
- Near-miss events that are not individually reportable as serious incidents
Serious Public Health Threats
A serious public health threat must be reported to Swissmedic within 2 calendar days. A serious public health threat is a situation where a device issue could affect a significant number of patients or could cause widespread harm if not immediately addressed (e.g. contaminated batch of diagnostic reagents used widely, systemic failure affecting implantable device class).
Trend Monitoring
Trend monitoring is an integral part of the PMS system. Manufacturers must establish thresholds and monitoring processes in their PMS plan and document trend monitoring activities in the PMS report or PSUR.
Official Sources
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