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.
|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.
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.