Ressources numériques en sciences humaines et sociales OpenEdition Nos plateformes OpenEdition Books OpenEdition Journals Hypothèses Calenda Bibliothèques OpenEdition Freemium Suivez-nous

MDCG 2023-2 – List of Standard Fees – January 2023

Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the requirement for notified bodies to make their standard fees publicly available: “Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available“. Neither the MDR nor the IVDR do provide any definition of “standard fees” itself.

The templates for “List of Standard Fees” provided in the guidance document are intended to assist notified bodies defining their list of fees for publication in accordance with MDR Article 50 and IVDR Article 46.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 12 January 2023.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (13 février 2023). MDCG 2023-2 – List of Standard Fees – January 2023. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o68e


Vous aimerez aussi...

Laisser un commentaire

Votre adresse e-mail ne sera pas publiée. Les champs obligatoires sont indiqués avec *

This site uses Akismet to reduce spam. Learn how your comment data is processed.