Medical device CE marking

WG/N43FINAL:2020 Adverse Event Report Terminologies for Reporting



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IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes. Including appendices A - G

IMDRF


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WG N43 2019 Adverse Event Report Terminologies for Reporting Annex G (Medical device component) 2021Download 
WG N43 2019 Adverse Event Report Terminologies for Reporting Annex F (Health effect) 2021Download 
WG N43 2019 Adverse Event Report Terminologies for Reporting Annex E (Clinical signs, symptoms) 2021Download 
WG N43 2019 Adverse Event Report Terminologies for Reporting Annex D (Investigation conclusion) 2021Download 
WG N43 2019 Adverse Event Report Terminologies for Reporting Annex C (Investigation findings) 2021Download 
WG N43 2019 Adverse Event Report Terminologies for Reporting Annex B (Type of investigation) 2021Download 
WG N43 2019 Adverse Event Report Terminologies for Reporting Annex A (Codes) 2021Download 
WG N43 2020 Adverse Event Report Terminologies for ReportingDownload 

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