Summary of safety and performance template

Name: Summary of safety and performance template
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: diagnostics,guidances,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,mdcg,medical-devices,performance,safety,summaries,templates

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

In Vitro Diagnostic Medical Devices (IVD)

Published

April 15, 2024

Last updated

April 15, 2024

Description

A document titled "Summary of safety and performance template" covering topics related to In Vitro Diagnostic medical devices (IVD).

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2022-9 rev.1

Updated on April 15, 2024

pdf

URL: https://health.ec.europa.eu/document/download/b7cf356f-733f-4dce-9800-0933ff73622a_en?filename=mdcg_2022-9_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/4e04e889-0347-454a-8cc2-26632043c759
MIME Type: application/pdf

Created on: April 15, 2024
Modified on: April 15, 2024