5 docs tagged with "vigilance"

Regulatory basis - MDR Art. 92 and Art. 100–105 / IVDR Art. 87 and Art. 97–102. EUDAMED is the central EU information system for medical devices, including the vigilance module for reporting serious incidents and FSCAs.

Regulatory basis - MDR Art. 87 / IVDR Art. 82 require reports to be submitted to the NCA of the member state(s) where the incident occurred. EUDAMED is the primary reporting platform; some NCAs also accept or require national-format reports.

Regulatory basis - MDR Art. 87(5)–(8) / IVDR Art. 82(5)–(8). Timeframes run from the date the manufacturer becomes aware of the incident. EUDAMED is the reporting platform for EU vigilance reports.

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.