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White Papers / Tech Papers

The Clock Is Ticking: Will Notified Body Capacity for the EU MDR Affect You?

By Edwin L. Bills, Consultant for Qosina

Released By Qosina

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 (NB) could affect timely implementation. The deadline is looming larger 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.

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