The compliance dates for the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are quickly approaching. In response, Treximo is hosting a webinar series that will cover a wide variety of pertinent subjects applicable to the device / diagnostics industries as they relate to the change in the regulatory framework in Europe.
The third training in our series was held on January 26, 2021 and featured a panel discussion and Q&A session with experts from TÜV SÜD, one of only a few Notified Bodies currently designated under both IVDR and MDR. Download their whitepaper on the topic by clicking here. Treximo’s Senior Vice President of Device and Diagnostics, Ronald Freeze, moderated the session. Panelists from TÜV SÜD were:
- Lisa Blanchard, Technical Manager (facilitator) (EN)ISO & MDSAP Conformity Assessment Procedure Specialist
- Daniel Moreno, Manager, Special Operations and Support
- Dr. Julien Senac, Global Director, IVD Focus Team
- Matthias Fink, M.D., Global Team Leader Ortho, Trauma and Dentistry of the Clinical Centre of Excellence
A full recording of the webinar can be accessed by clicking on the image below.
During the event, the experts discussed:
- The sequence of events from pre-application to certification
- IVDR identified bottlenecks with Notified Body workload and infrastructure
- The importance of intended purpose
- Relevant changes for the clinical evaluation under the MDR
- Higher scrutiny on demonstration of equivalence for initial CE marking
- Post-market surveillance requirements
Part four of the series will be Tuesday, March 23rd and cover “The Top Considerations an EU MDR / IVDR Project Lead Should Have (Before / After Implementation).” Learn more here.