Under the new regulation, manufacturers will need to report all serious incidents and field safety corrective actions to competent authorities via the EUDAMED database.
Serious incidents must be reported within these timeframes:
- Immediately, but no later than 2 days post incident if it represents a serious threat to public health
- Immediately, but no later than 10 days post incident if it involves a death
- Immediately, but no later than 15 days post incident if it has little to no consequence to patient or user
(*Note: The reporting period was 30 days under previous regulations)
If necessary, a partial report can be submitted initially to meet these deadlines.
Field safety corrective actions must be reported to a competent authority before implementation unless the safety of the patient is at risk and the corrective action needs to be taken immediately.