Reporting timeframes
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. 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.