Overview of the In-Vitro Diagnostic Medical Device Regulatory Landscape

Filmed on October 2, 2024 - This webinar will provide an overview of the current state and upcoming updates of the IVD regulatory requirements, including a brief introduction and transition timeline of the 2017/746 EU IVDR as well as the US FDA’s revised approach to regulating Laboratory Developed Tests, etc. 0:00 Introduction 3:25 What is an IVD? 7:28 Non-IVD examples 8:52 Associated products 13:50 IVD Companion Diagnostics (CDx) 16:30 What software is IVD? 17:54 IVDD to IVDR Transition 20:41 Why IVDR? 23:47 EU Regulation 2024/1860 - IVDD validity extension 29:26 IVDR classification 33:47 Instruments and software classification 36:15 Conformity routes by class IVDR vs MDR 38:58 Key requirements by class - TDA sampling 39:30 Key requirements by class - PMS 40:01 IVDR Devices with specific requirements 42:23 Common specifications 42:53 EU Reference Labs (EURLs) 44:47 FDA - Laboratory developed tests 47:09 LDT implementation steps 49:57 Q&A Speakers Balazs Bozsik - Technical Director - Medical Audit, SGS Greg Jacobson - Sales Director - Medical Devices, SGS Learn more: https://try.sgs.com/en-us/medical-dev... Follow us on LinkedIn: https://bit.ly/44lmAY1