IMDRF document
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
IMDRF Technical document · IMDRF/AE WG/N43FINAL:2020 (Edition 4) · posted Apr 20, 2020
Key facts
| Title | Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes |
|---|---|
| Document reference | IMDRF/AE WG/N43FINAL:2020 (Edition 4) |
| Issued by | IMDRF |
| Document category | Technical document |
| Posted | Apr 20, 2020 |
| IMDRF page | imdrf.org |
| Document file | imdrf.org |
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About IMDRF and GHTF documents
IMDRF is a forum of medical device regulators that writes harmonised guidance, such as the MDSAP audit documents and the UDI, SaMD and adverse-event terminology documents. It also hosts the archived documents of its predecessor, the Global Harmonization Task Force (GHTF).
Source: International Medical Device Regulators Forum (IMDRF), including the archived documents of the Global Harmonization Task Force (GHTF) · Source date: