The International Medical Device Regulators Forum (IMDRF) has released an updated version of its “Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology and Codes” document. This updated version “Consolidated Annexes A-G” was published on March 3, 2025.
Overview of changes:
- Annex A: Added 3 new terms (A0416, A072203, A150106) and modified 16 terms (A02, A0207, A040607, A0504, A050408, A071209, A0717, A0723, A090813, A110201, A15, A150104, A22, A2201, A26, A27) and retired 3 terms (A0202, A0203, A0204)
- Annex B: Added 7 new terms (B26, B27, B28, B29, B30, B31, B32) and retired 1 term (B08)
- Annex C: Modified 13 terms (C020702, C0302, C0305, C040102, C0404, C070601, C070603, C1205, C1206, C1208, C1403, C1502, C22).
- Annex D: Modified 3 terms (D0105, D1001, D17).
- Annex E: Added 19 new terms (E0522, E0523, E0628, E0629, E0759, E0760, E0761, E0860, E0911, E0912, E0913, E1213, E1214, E1215, E1652, E1729, E2131, E2132, E2352) and modified 13 terms (E0110, E0111, E0624, E0627, E0732, E0845, E120501, E1648, E2008, E201401, E2121, E24, E2402) and retired 3 terms (E0138, E0753, E2107)
- Annex F: Added 6 new terms (F0802, F1009, F1010, F2309, F30, F31) and modified 8 terms (F10, F1008, F11, F1908, F1910, F2303, F24, F28) and retired 1 term (F1006).
- Annex G: Added 2 new terms (G0201208, G02041) and modified 3 terms (G07, G07002, G07003).
For a complete list of comments and IMDRF decisions, please refer to the Change Request Log published along with this release.
The deadline for Change Requests for next year’s maintenance cycle is September 1st, 2025.
For more information, please contact your MDSS team.
