Join TDV’s webinar “Regulatory environment In Vitro Diagnostic Medical Devices (IVDR)” on January 25th – #BHHMembersInitiatives
BHH member TDV is organizing a webinar on Tuesday January 25 at 10hrs CET about “Regulatory environment In Vitro Diagnostic Medical Devices (IVDR)“.
In this webinar TDV will present the main requirements for the design, manufacture and marketing of In Vitro Diagnostic Medical Devices under the new European regulation 2017/746. They will discuss the main changes compared to the previous European directive and highlight the feedback received by Notified Bodies in the certification of new and legacy products.
In this webinar you will:
- learn about the new regulatory environment 2017/746 (IVDR) for IVD and highlight differences with directive 98/79/EC (IVDD).
- learn about the new IVD classification.
- understand the IVD CE certification process.
- define the role of the Person Responsible for Regulatory Compliance.
- discover the expected content of the Technical File.
This webinar might interest you if you are a professional in the medical devices sector, mainly belonging to the Quality Assurance and Regulatory Affairs departments, as well as R&D and in vitro diagnostic product design and development.