Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes

Name: Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
Creator: International Medical Device Regulators Forum
Keywords: adverse-events,appendixes,changes,events,findings,imdrf,impact,investigation,medical-devices,reporting

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Type

Technical document

Regulated products

Medical Devices

Last updated

March 7, 2024

Description

Technical document: IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually Current release: IMDRF/AE WG/N43FINAL:2024 Updated Annexes 20 April 2024; Annex A_1 – updated 9 May 2024 (refer release notes for details)

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International Medical Device Regulators Forum (IMDRF) 🌍

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Worldwide

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18 Main files

Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes

Updated on April 20, 2020

pdf (1.2MB)

URL: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-ae-terminologies-n43.pdf
Permalink: https://data.openrid.co/en/datasets/r/f688813d-9e0e-4946-b2eb-570e0ea49d1b
MIME Type: application/pdf

Created on: April 20, 2020
Modified on: April 20, 2020

Size: 1.2MB

IMDRF code: IMDRF/AE WG/N43FINAL:2020 (Edition 4)

Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes

Updated on April 20, 2020

docx (279.8KB)

URL: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-ae-terminologies-n43.docx
Permalink: https://data.openrid.co/en/datasets/r/03eef904-a0fd-4fc7-90c6-42a504b73cda
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: April 20, 2020
Modified on: April 20, 2020

Size: 279.8KB

IMDRF code: IMDRF/AE WG/N43FINAL:2020 (Edition 4)

Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem

Updated on March 7, 2024

json (170.8KB)

URL: https://www.imdrf.org/sites/default/files/2024-05/annexa2024_1.json
Permalink: https://data.openrid.co/en/datasets/r/2e24c777-dffa-470c-b8a5-0d74a8a2ad18
MIME Type: application/json

Created on: March 7, 2024
Modified on: March 7, 2024

Size: 170.8KB

IMDRF code: IMDRF/AE WG/N43FINAL:2024 Updated Annexes (Release No. 2024)

Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem

Updated on March 7, 2024

xlsx (60.3KB)

URL: https://www.imdrf.org/sites/default/files/2024-05/imdrf-tech-ae-terminologies-n43-ReleaseNumber2024_1-AnnexA_0.xlsx
Permalink: https://data.openrid.co/en/datasets/r/f3d2a515-d407-4a2c-94a7-ffd5cb53221b
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: March 7, 2024
Modified on: March 7, 2024

Size: 60.3KB

IMDRF code: IMDRF/AE WG/N43FINAL:2024 Updated Annexes (Release No. 2024)

Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation

Updated on March 7, 2024

xlsx (21.5KB)

URL: https://www.imdrf.org/sites/default/files/2024-03/imdrf-tech-ae-terminologies-n43-ReleaseNumber2024-AnnexB_0.xlsx
Permalink: https://data.openrid.co/en/datasets/r/4e7bf279-43ef-4181-9c9d-d7949bf59f3b
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: March 7, 2024
Modified on: March 7, 2024

Size: 21.5KB

IMDRF code: IMDRF/AE WG/N43FINAL:2024 Updated Annexes (Release No. 2024)

Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation

Updated on March 7, 2024

json (14.0KB)

URL: https://www.imdrf.org/sites/default/files/2024-03/annexb2024_0.json
Permalink: https://data.openrid.co/en/datasets/r/2685425b-499b-44fb-bbc7-74798517ee18
MIME Type: application/json

Created on: March 7, 2024
Modified on: March 7, 2024

Size: 14.0KB

IMDRF code: IMDRF/AE WG/N43FINAL:2024 Updated Annexes (Release No. 2024)

See the 18 main files

Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes

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