This page contains a comprehensive set of resources for reporters to use when selecting event codes in an MDR.
Current MDR Adverse Event Codes
The FDA MDR adverse event codes are divided into six code types. The table below contains a link to the hierarchy for each code type, which lists all active codes of that type and their relationships.
|Code Type||Hierarchy Link|
|Device Problem Code||DPC hierarchy|
|Manufacturer Evaluation Method Code||EMC hierarchy|
|Manufacturer Evaluation Result Code||ERC hierarchy|
|Manufacturer Evaluation Conclusion Code||ECC hierarchy|
|Patient Problem Code||PPC hierarchy|
|Device Component Code||DCC hierarchy|
Reporters should read and familiarize themselves with the hierarchies above before filing an MDR.
IMDRF Adverse Event Code Harmonization
FDA is in the process of harmonizing the FDA adverse event coding system with the new IMDRF Adverse Event Reporting terminologies, a new international guideline for coding medical device adverse events. As the first step in this process, FDA updated four of its code sets (Device Problem Code, Manufacturer Evaluation Method Code, Manufacturer Evaluation Result Code, and Manufacturer Evaluation Conclusion Code) to have a one-to-one matching with the first four code sets from IMDRF on July 5, 2018. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as the remaining annexes are published.
The hierarchy files above contain the new set of codes, terms, definitions, and relationships for the four newly-harmonized code sets. The hierarchies also contain the mapping between FDA, NCIt, and IMDRF codes in each set.
The disposition files below list what codes have been retired from each set during the IMDRF harmonization effort. They also contain guidance for reporters on what code to choose if a preferred code was retired.
|Device Problem Code||DPC Disposition|
|Manufacturer Evaluation Method Code||EMC Disposition|
|Manufacturer Evaluation Result Code||ERC Disposition|
|Manufacturer Evaluation Conclusion Code||ECC Disposition|
For more information about IMDRF, please view the top-level Adverse Event Codes page.