In July, we published a white paper on the progress of the new European Union Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) and how the lack of Notified Bodies could affect timely implementation. The May 2020 (2022 for IVDR) deadline is looming large and some small progress has been made, along with some steps backward. This paper has been updated to reflect the most recent developments and to bring the current situation into focus.
In this paper, you will learn more about:
- The addition of Notified Bodies and whether or not the number is sufficient
- The impending Brexit deadline and its effect on the MDR transition
- Progress on the Eudamed database
- ISO standards and their impact on MDR/IVDR