Appendix: Clinical investigation summary safety report form

Name: Appendix: Clinical investigation summary safety report form
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: appendixes,clinical-investigation,forms,guidances,investigation,mdcg,reporting,safety,safety-report-form,summaries

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Clinical Investigation And Evaluation

Published

October 1, 2022

Last updated

October 1, 2022

Description

This document is an appendix that provides a summary safety report form for clinical investigations and evaluations.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

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1 Main file

MDCG 2020-10/2 Rev. 1

Updated on September 6, 2023

xlsx

URL: https://health.ec.europa.eu/document/download/bf136f27-27da-4a31-97c2-a5de741c3493_en?filename=md_mdcg_2020-10-2_guidance_safety_report_form_en.xlsx
Permalink: https://data.openrid.co/en/datasets/r/b4103493-0bfb-443e-bbe2-d192b5fce1d4
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: September 6, 2023
Modified on: September 6, 2023