Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Name: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: eu,european-union,exemptions,guidances,in-house,mdcg,regulations

Information

Type

Guidance

Regulated products

Medical Devices

Topics

In-House Devices

Published

January 1, 2023

Last updated

January 1, 2023

Description

Guidance on health institution exemption for in-house devices under EU regulations 2017/745 and 2017/746.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2023-1

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/05b15d55-1bcf-4e17-99c4-15c706325847_en?filename=mdcg_2023-1_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/c6017cca-0057-418f-8782-60fd444335d8
MIME Type: application/pdf

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