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 www.imdrf.org.