Andreas Stange, Vice President MHS global IVD at TÜV SÜD, presented a session at MedTech Summit 2020 offering an update on EU IVDR implementation from the perspective of a Notified Body. The session included:
- Feedback on the timeline for Notified Body designation and current designations received
- The impact on workload for the Notified Bodies with designations and how this will impact industry
- Defining the standards, clarifying the requirements and understanding what Notified Bodies are looking for from industry
- Advice for industry on how to best prepare for the IVD audit and what to expect
- EU IVD Regulation and Strategy
Watch the full on-demand session by clicking on the video right.
