Medical Devices

Coding Resources

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 TypeHierarchy Link
Device Problem CodeDPC hierarchy
Manufacturer Evaluation Method CodeEMC hierarchy
Manufacturer Evaluation Result CodeERC hierarchy
Manufacturer Evaluation Conclusion CodeECC hierarchy
Patient Problem CodePPC hierarchy
Device Component CodeDCC hierarchy

Reporters should read and familiarize themselves with the hierarchies above before filing an MDR.

Future IMDRF Harmonized Adverse Event Codes

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 will update 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.

This update will take place on July 5, 2018. After this date, reporters will be required to use the updated set of codes described below in all MDRs. For more information about the IT/software impact of these changes, please visit the eMDR system enhancements page. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as the remaining annexes are published.

The hierarchy files below contain the new set of codes, terms, definitions, and relationships in the 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. They also contain guidance for reporters on what code to choose if a preferred code was retired.

Code TypeHierarchyDisposition
Device Problem CodeDPC HierarchyDPC Disposition
Manufacturer Evaluation Method CodeEMC HierarchyEMC Disposition
Manufacturer Evaluation Result CodeERC HierarchyERC Disposition
Manufacturer Evaluation Conclusion CodeECC HierarchyECC Disposition

For more information about IMDRF, please view the top-level Adverse Event Codes page.

Page Last Updated: 04/06/2018
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