About Adverse Event Reports

A problem that occurred with medical equipment is considered an adverse event. All adverse events must be reported to the regulatory authorities of respective countries. An adverse event report (AER) is a document that contains information about the adverse event. This document, a .pdf file, is submitted to the regulatory authority electronically or manually.

This page discusses:

See Also
Adverse Event Reports
Adverse Event Report Properties

Adverse Event Reports

Adverse event reporting is a process that allows you to record information from the complaint investigation, create an AER, provide necessary regulatory information, and submit the report.

Four types of AERs are available.

  • MDR: follows regulations based on U.S. FDA standards
  • CMDR: follows regulations based on Health Canada standards
  • MDV: follows regulations based on European National Competent Authority standards
  • PMDA: for submissions in Japan

A regulatory user can create all four types of AERs manually or by using a decision tree.