Les études des performances DMDIV selon le règlement 2017/746 - webinaire #8

Eighth 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. The webinar topic is: IVDMD performance studies ▬▬▬▬▬▬▬▬▬▬▬ TO LEARN MORE ▬▬▬▬▬▬▬▬▬▬▬ 🔗 Video presentations: https://ansm.sante.fr/evenements/webi... 📂 More information in our guide: https://ansm.sante.fr/documents/refer... 🏷️ Requesting authorization for an IVDMD performance study: https://ansm.sante.fr/vos-demarches/i... ℹ️Innovation and Guidance Helpdesk: https://ansm.sante.fr/vos-demarches/i... ▬▬▬▬▬▬▬▬▬▬▬ VIDEO SUMMARY ▬▬▬▬▬▬▬▬▬▬▬ 00:00 Introduction 00:01:48 Performance Study Evaluation Procedure (DGS) 00:23:10 Performance Evaluation and Performance Studies 00:29:22 Documentation according to European regulations 2017/746 00:34:12 Performance studies and other research on IVDs 00:41:50 Cases of research on IVDs not covered by the regulation 01:01:25 Submission of dossiers 01:02:54 Processing times 01:04:12 5-month review 01:04:46 Substantial modifications 01:05:57 Vigilance of performance studies 01:12:28 Conclusions 01:15:50 Questions and answers #ANSM #MedicalDevices