MDCG 2021-15 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) – July 2021 MDCG 2021-16 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) – July 2021

3 Sep 2021 | MDCG, Toutes les actualités

Thème Désignation des organismes notifiés Public visé Organismes d’évaluation de la conformité Produits concernés DM & DMDIV Documents cités RDM (UE) 2017/745 RDMDIV (UE) 2017/746 Ces guides MDCG (15 & 16) correspondent aux formulaires à remplir par les...

MDCG 2021-13 Rev. 1 : 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 – June 2021

10 Juil 2021 | MDCG

Thème EUDAMED Public visé Opérateurs autres que les fabricants, mandataires et importateurs Produits concernés DM  et DMDIV Documents cités RDM (UE) 2017/745 RDMDIV (UE) 2017/746 MDCG 2019-5 MDCG 2021-3   Ce document fournit des informations concernant les...