Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices

Name: Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: coronavirus,covid,covid-19,diagnostics,guidances,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,mdcg,medical-devices,performance,performance-evaluation,sars-cov-2,testing

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

COVID-19

Published

February 1, 2022

Last updated

February 1, 2022

Description

Guidance on evaluating COVID-19 diagnostic devices, focusing on SARS-CoV-2 performance. Important for in vitro testing.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2021-21 Rev.1

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/729f09dc-9f95-40b9-a62a-a0e9fff1d252_en?filename=mdcg_2021-21_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/28c7a66e-861f-4233-8312-74553ecfc4da
MIME Type: application/pdf

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