Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence

Name: Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: access,claims,clinical-investigation,data,exemptions,guidances,investigation,mdcg,mdr,medical-devices-regulations,requirements

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Clinical Investigation And Evaluation

Published

December 1, 2023

Last updated

December 1, 2023

Description

Document provides guidance on exemptions from clinical investigations under MDR Article 61(4)-(6) and access to data for claims of equivalence.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2023-7

Updated on March 23, 2024

pdf

URL: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/433daf28-526c-49c6-84fe-5aa55453f666
MIME Type: application/pdf

Created on: March 23, 2024
Modified on: March 23, 2024