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 second webinar in our series was held on November 10, 2020 and focused on “Understanding the Concept of a CEP in the Context of MDR.” Treximo’s Senior Director of Device and Diagnostics Writing Belinda (Binnie) Larson and Senior Vice President of Device and Diagnostics Ronald Freeze hosted the session.
A full recording of the webinar can be accessed by clicking on the image below.
During the training, Binnie covered how to prepare for a compliant clinical evaluation plan for the MDR, including:
- required elements laid out in the MDR
- expectations for legacy devices
- standard expectations not detailed in either the MDR or the Medical Device Coordination Group (MDCG) guidance documents
Part three of the series will be Tuesday, December 8th and feature a panel discussion and Q&A session with TÜV SÜD, one of the world’s leading Notified Bodies providing conformity assessment services related to medical devices. Register here.