Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC

Name: Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: applications,directives,eu,european-union,guidances,in-vitro-diagnostics-regulation,ivdr,legacy-devices,markets,mdcg,regulations,requirements

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

In Vitro Diagnostic Medical Devices (IVD)

Published

May 1, 2022

Last updated

May 1, 2022

Description

Regulation (EU) 2017/746 applies IVDR requirements to 'legacy devices' and devices placed on the market before 26 May 2022.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2022-8

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/cac817ee-00dd-4923-9593-6e19520010ee
MIME Type: application/pdf

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