MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate

Name: MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: active-implantable-medical-devices,aimdd,applications,certificates,guidances,legacy-devices,mdcg,mdd,mdr,medical-devices-directives,medical-devices-regulations

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Published

December 1, 2022

Last updated

December 1, 2022

Description

This document discusses the application of Article 97 MDR to legacy devices with expired MDD or AIMDD certificates.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

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1 Main file

MDCG 2022-18

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/ccfb20a8-82d4-4216-8d11-4ce127be431e_en?filename=mdcg_2022-18_en_1.pdf
Permalink: https://data.openrid.co/en/datasets/r/e5707b20-2f04-43d6-a21d-c59754d5c507
MIME Type: application/pdf

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