50 ? false : true)" >
STATE INSTITUTE
FOR DRUG CONTROL
Drug database
Search on the web…
Search on the web…
MENU
EN
CS
Change language
About us
Public
Healthcare Professionals
Pharmaceutical Industry
Important information
Reporting
Drug database
EN
CS
Change language
Homepage
Pharmaceutical Industry
Medical devices
Vigilance
Reporting – Medical Devices
Serious Incident Reporting
IMDRF Documents
IMDRF Documents
On the IMDRF website, you can find document IMDRF/AE WG(PD1) /N43 FINAL:2020 (Edition 4.1):
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes on the terminology to be used for serious incident reporting, incl. annexes A-G.
Annexes A-G consolidated Excel Workbook 2025