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
The FDA is in the process of harmonizing the FDA adverse event coding system with the new International Medical Device Regulators Forum (IMDRF) Adverse Event Reporting terminologies, a new international guideline for coding medical device adverse events.
As the first step in this process, the 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. The hierarchy files above contain the set of codes, terms, definitions, and relationships for the four harmonized code sets. The hierarchies also contain the mapping between the FDA, NClt codes via the eMDR system. The hierarchy for Device Problem Code will also have maintenance updates, including new terms.
The final step in this process will take place on September 7, 2020, when the FDA will harmonize with the remaining IMDRF code sets (Health Effect Clinical Code, Health Effect Impact Code, and Medical Device Component Code). In addition to harmonizing the FDA Patient Problem Code and Device Component Code sets with IMDRF, the FDA will accept IMDRF, FDA, and NCIt codes through the eMDR system. The hierarchy for Device Problem Code will also have maintenance updates, including new terms.
The hierarchy files below contain the new set of codes, terms, definitions, and relationships for the three newly-harmonized code sets. They also contain the mapping between the FDA, NClt, and IMDRF codes in each set. Note that Device Component Code will be contained in a separate field in eMDR and eSubmitter and component codes will no longer be accepted in the Device Problem Code or Manufacturer Evaluation Result (Investigation Findings) Code fields. Reporters should familiarize themselves with the new hierarchies below so that they will be prepared to use the harmonized codes in MDRs, starting on September 7, 2020.
|Health Effect Clinical Code (maps to Patient Problem Code)||HECC Hierarchy|
|Health Effect Impact Code (new)||HEIC Hierarchy|
|Device Component Code||DCC Hierarchy|
|Device Problem Code (maintenance update)||DPC Hierarchy|
The disposition files below list what codes have been retired from each set during the IMDRF harmonization effort.
|Device Problem Code||DPC Disposition|
|Manufacturer Evaluation Method Code||EMC Disposition|
|Manufacturer Evaluation Result Code||ERC Disposition|
|Manufacturer Evaluation Conclusion Code||ECC Disposition|
|Patient Problem Code||PPC Disposition|
|Device Component Code||DCC Disposition|
For more information about IMDRF, please view the top-level Adverse Event Codes page.