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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)