EUDAMED user guide Vigilance for EOs

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)