By Edwin L. Bills, Consultant for Qosina
Explore 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 recent developments and to bring the current situation into focus.
As of October 2019, there are five approved NBs for the MDR: BSI UK, TÜV SÜD, TÜV Rheinland, DEKRA and IMQ S.p.A. DEKRA is also approved as the first NB for IVDR. However, while the addition of NBs is certainly a positive development, there are still not nearly enough to handle the necessary workload to continue all devices and IVDs on the market, let alone introduce any new products into the European marketplace.