Basic Concepts – types of Vigilance & Post-Market Surveillance reports
For the current EUDAMED Playground release, the following types of reports can be managed:
MIR (Manufacturer Serious Incident Report)
FSCA (Field Safety Corrective Action)
PSUR (Periodic Safety Update Report)
NCAR (National Competent Authority Report)
MTR (Manufacturer’s Trend Report)
FSN (Field Safety Notice)
PSR (Periodic Summary Report)
PSRP (PSR Periodic Analysis Update)