Guidance on sampling of devices for the assessment of the technical documentation

Name: Guidance on sampling of devices for the assessment of the technical documentation
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: assessment,guidances,mdcg,notified-bodies,sampling,technical-documentation

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Notified Bodies

Published

December 1, 2019

Last updated

December 1, 2019

Description

Guidance on sampling of devices for technical documentation assessment, focusing on Notified bodies.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2019-13

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/36268741-3591-4130-ad21-b09487ff2074_en?filename=md_mdcg_2019_13_sampling_mdr_ivdr_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/c97a755b-09f8-4581-9d93-8be9483c6427
MIME Type: application/pdf

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