Is your software a Medical Device?

Name: Is your software a Medical Device?
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: classification,guidances,medical-devices,samd,software,software-as-a-medical-device

Information

Type

Guidance

Regulated products

Medical Devices

Topics

New Technologies

Published

March 1, 2021

Last updated

March 1, 2021

Description

Is your software a Medical Device?" - A document discussing the classification of software as a medical device, focusing on new technologies.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

Infographic

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/b865d8e9-081a-4601-a91a-f120321c0491_en?filename=md_mdcg_2021_mdsw_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/17503276-3194-4a3d-87e1-9ff073c58fee
MIME Type: application/pdf

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