Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Name: Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: classification,eu,european-union,guidances,mdcg,qualification,regulations,software

Information

Type

Guidance

Regulated products

Medical Devices

Topics

New Technologies

Published

October 1, 2019

Last updated

October 1, 2019

Description

This document discusses the qualification and classification of software under EU regulations, with a focus on new technologies.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2019-11

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=md_mdcg_2019_11_guidance_qualification_classification_software_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/60704312-4b67-4316-bbee-255d3afb2fdf
MIME Type: application/pdf

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