2 docs tagged with "serious-incidents"

Regulatory basis - MDR Art. 2(65) and Art. 87 / IVDR Art. 2(67) and Art. 82. The definitions of serious incident and near-miss determine the scope of mandatory vigilance reporting.

Regulatory basis - MDR Art. 87 and IVDR Art. 82 define the reporting obligations for serious incidents and field safety corrective actions. Manufacturers must report to the National Competent Authority of the member state(s) where the incident occurred or the FSCA is being taken.