Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software

Name: Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: clinical-evaluation,guidances,in-vitro-diagnostics-regulation,ivdr,mdcg,mdr,medical-devices,medical-devices-regulations,performance,performance-evaluation,software

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

New Technologies

Published

March 1, 2020

Last updated

March 1, 2020

Description

Guidance on clinical evaluation and performance evaluation of medical device software, with a focus on new technologies.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

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1 Main file

MDCG 2020-1

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/19d9e24f-2808-4e00-bfeb-75892047407d_en?filename=md_mdcg_2020_1_guidance_clinic_eva_md_software_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/de98850e-4e90-43a1-8cd5-6c8b4474ea27
MIME Type: application/pdf

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