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  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



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