Substantial modification of performance study under Regulation (EU) 2017/746

Name: Substantial modification of performance study under Regulation (EU) 2017/746
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: changes,diagnostics,eu,european-union,guidances,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,mdcg,medical-devices,performance,regulations,significant-changes,substantial

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

In Vitro Diagnostic Medical Devices (IVD)

Published

December 1, 2022

Last updated

December 1, 2022

Description

This document discusses the significant changes made to performance studies for In Vitro Diagnostic medical devices (IVD) under Regulation (EU) 2017/746.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

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1 Main file

MDCG 2022-20

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/6a354f46-8308-4d60-a36d-2ef1ba56e41a_en?filename=mdcg_2022-20_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/b63b3980-e299-41ee-8aca-62c0d20ca24c
MIME Type: application/pdf

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