La vigilance selon les nouveaux règlements DM 2017/745 et DMDIV 2017/746 - Webinaire #7

Seventh webinar on the entry into force of the European regulation on medical devices and in vitro diagnostic medical devices (IVDs) according to Regulation (EU) 2017/745 and 2017/746. Topics covered include: the impact of the new regulations and the updated Medical Devices Ordinance, the organization of the ANSM (French National Agency for Medicines and Health Products Safety) following the new regulations, the ANSM's expectations regarding declarations. ▬▬▬▬▬▬▬▬▬▬▬ TO LEARN MORE ▬▬▬▬▬▬▬▬▬▬▬ 🔗 Video presentations: https://ansm.sante.fr/evenements/webi... 📂 More information in our dossier: https://ansm.sante.fr/documents/refer... ▬▬▬▬▬▬▬▬▬▬▬ VIDEO SUMMARY ▬▬▬▬▬▬▬▬▬▬▬ 00:00 Opening Credits 00:00:09 Introduction by Thierry Sirdey, Director of the Medical Devices, Cosmetics, and In Vitro Diagnostic Devices Department 00:02:45 Impact of the new regulations and the updated Medical Device Ordinance 00:23:43 ANSM's reorganization following the new regulations 00:42:20 Expected outcomes ANSM regarding declarations 00:52:35 Q&A #ANSM #MedicalDevices