Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

Name: Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: authorized-representatives,eudamed,guidances,importers,in-vitro-diagnostics-regulation,ivdr,manufacturers,mdcg,mdr,medical-devices-regulations,obligations,q-a,questions-and-answers,registrations,rules

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

EUDAMED

Published

July 1, 2021

Last updated

July 1, 2021

Description

This document provides information on the registration obligations in EUDAMED for actors other than manufacturers, authorized representatives, and importers.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2021-13 Rev. 1

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/8e9adf30-71b5-4faf-a8fb-b35ce4804440_en?filename=md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/a00ce8c3-1bd7-483b-8550-7698e740200b
MIME Type: application/pdf

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