Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746

Name: Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: certification,clarifications,consultations,diagnostics,eu,european-union,expert-panel,guidances,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,mdcg,medical-devices,notified-bodies,procedures,regulations

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

In Vitro Diagnostic Medical Devices (IVD)

Published

September 1, 2022

Last updated

September 1, 2022

Description

This document provides clarification on the first certification for in vitro diagnostic medical devices and the procedures for notified bodies to follow.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

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1 Main file

MDCG 2021-22 rev.1

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/98db0ec5-306f-4a0d-8bc9-5724f5d48942_en?filename=mdcg_2021-22_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/c184b92b-47a2-46c9-9fc6-4dcf8ce74f69
MIME Type: application/pdf

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