Guidance on sufficient clinical evidence for legacy devices

Name: Guidance on sufficient clinical evidence for legacy devices
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: clinical-evidence,clinical-investigation,evidence,guidances,investigation,legacy-devices,mdcg

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Clinical Investigation And Evaluation

Published

April 1, 2020

Last updated

April 1, 2020

Description

This document provides guidance on obtaining sufficient clinical evidence for legacy devices, focusing on clinical investigation and evaluation.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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2 Main files

MDCG 2020-6

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/a6d29444-b5d5-4afb-8024-10be85256aa7_en?filename=md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/828094d3-efd6-4950-a204-21e560f496f3
MIME Type: application/pdf

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

Background note