IMDRF Coding for Adverse Events

The IMDRF guidance document IMDRF/AE WG/N43FINAL:2017 Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology structure, and Codes proposes a common system adverse event reporting.

The system uses four distinct sets of terminologies and their associated codes. In general, the codes have a hierarchal structure.

  • Medical Device Problem terms/codes
  • Cause investigation terms/codes
  • Patient problem terms/codes
  • Component terms/codes
    • IMDRF is still developing the system, but when complete it will allow consistent interchange of information between regulators.

      The IMDRF website is