Substantial modification of clinical investigation under Medical Device Regulation

Name: Substantial modification of clinical investigation under Medical Device Regulation
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: changes,clinical-investigation,guidances,investigation,mdcg,mdr,medical-devices,medical-devices-regulations,regulations,significant-changes,substantial

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Clinical Investigation And Evaluation

Published

December 1, 2021

Last updated

December 1, 2021

Description

Learn about the significant changes in clinical investigation under the Medical Device Regulation.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2021-28

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/ba8069a1-6881-4360-b52b-6cab048aee43_en?filename=mdcg_2021-28_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/f12f5456-eec4-45ee-9b94-3130246f9837
MIME Type: application/pdf

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