Technical document
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
IMDRF code:
IMDRF/AE WG/N43FINAL:2021 Updated Annexes (Edition 5.0)
Published date:
Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem
Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation
Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Findings
Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Conclusion
Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Clinical Signs and Symptoms or Conditions
Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Health Impact
Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Component
Appendix B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Change Log
Release Notes: IMDRF terminologies for categorized Adverse Event Reporting (AER)
IMDRF code:
IMDRF/AE WG/N43 FINAL:2020 Updated Annexes (Edition 4.1)
Published date:
Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem
Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation
Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Findings
Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Conclusion
Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Clinical Signs and Symptoms or Conditions
Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Health Impact
Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Component
Release Notes: IMDRF terminologies for categorized Adverse Event Reporting (AER) Edition 4.1
IMDRF code:
IMDRF/AE WG/N43 FINAL:2020 Annexes (Edition 4.0)
Published date:
Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes
Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER): Type of investigation
Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER): Investigation Findings ('what were the findings?')
Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER): Investigation Conclusion
Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) Health Effect - Clinical Signs, Symptoms and Conditions
Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) Health Effect - Health Impact
Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER): Medical Device Parts and Component Terms and Codes
IMDRF code:
IMDRF/AE WG(PDl)/N43 (Edition 3) FINAL:2019
Published date:
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes
Annex A: Reference Mapping
Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER): Type of investigation
Annex B: Reference Mapping
Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER): Investigation Findings ('what were the findings?')
Annex C: Reference Mapping
Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER): Investigation Conclusion
Annex D: Reference Mapping
Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) Health Effect – Clinical Signs, Symptoms and Conditions
Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) Health Effect – Health Impact
IMDRF code:
IMDRF/AE WG/N43 FINAL:2022 Updated Annexes (Release 2022)
Published date:
Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem
Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation
Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Findings
Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Conclusion
Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Clinical Signs and Symptoms or Conditions
Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Health Impact
Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Component
Appendix B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Change Log
Release Notes: IMDRF terminologies for categorized Adverse Event Reporting (AER)
IMDRF code:
IMDRF/AE WG/N43FINAL:2023 (Release No. 2023)
Published date:
Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem
Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation
Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Findings
Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Conclusion
Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Clinical Signs and Symptoms or Conditions (Version 2.2 - 2Aug23)
Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Health Impact
Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Component
Appendix B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Change Log
Release Notes: IMDRF terminologies for categorized Adverse Event Reporting (AER)