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  1. MDR Adverse Event Codes

Coding Resources for Medical Device Reports

This page contains a comprehensive set of resources for reporters to use when selecting event codes in a Medical Device Report (MDR) and contains information about the codes and the MedWatch Medical Device Reporting Code Instructions, sometimes referred to as the coding manual.

Current MDR Adverse Event Codes

The FDA MDR adverse event codes are divided into seven code types. The list 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
Medical Device Problem Annex A
Medical Device Component Annex G
Cause Investigation - Type of Investigation Annex B
Cause Investigation - Investigation Findings Annex C
Cause Investigation - Investigation Conclusion Annex D
Health Effects - Clinical Signs and Symptoms or Conditions Annex E
Health Effects - Health Impact Annex F

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

Previous Updates

The list below contains summaries of previous updates to the FDA MDR adverse event codes.

March 5, 2021 Update: IMDRF 2021 Maintenance

  • Annex A: Modified 2 terms (A0908, A15)
  • Annex B: Added 1 new term (B23) and modified 1 term (B16).
  • Annex C: Added 1 new term (C23) and modified 1 term (C19).
  • Annex D: Added 4 new terms (D0107, D0108, D1501, D18) and modified 3 terms (D10, D1107, D12).
  • Annex E: Added 2 new terms (E2120, E2342) and modified 23 terms (E0105, E010904, E0115, E0135, E0304, E0508, E0710, E0749, E082901, E0835, E0843, E1101, E1305, E1409, E1412, E1625, E1904, E1905, E2106, E2119, E231201, E231501, E2336). Updated NCIt mapping for E1001.
  • Annex F: Modified 5 terms (F14, F2204, F2305, F25, F26)
  • Annex G: Modified 9 terms (G02011, G0201501, G02020, G03006, G0405202, G04095, G04130, G0600102, G0600601). Updated NCIt mapping for G03008 and G04077.
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