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

Update – MDCG 2019-7 – Rev.1 – Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a PRRC – December 2023

Article 15 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduces the new role of a person responsible for regulatory compliance (PRRC), and the obligation for a manufacturer and authorised representative to have such a person at their disposal.
The document provides guidance on the roles and obligations of the PRRC and is addressed to manufacturers, authorised representatives and PRRCs.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 19 December 2023.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (13 février 2024). Update – MDCG 2019-7 – Rev.1 – Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a PRRC – December 2023. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/vto8


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.