At the Team-NB general assembly meeting, held on October 9th, the members aligned on a
strategy including operational aspects to respond to the concerns regarding the difficulties
encountered with the implementation of the MD and IVD Regulations (MDR and IVDR).
Notified Bodies play a critical role in the implementation of the MDR and IVDR by ensuring
the safety and performance of medical devices and IVDs that are placed on the EU market.
Team-NB members have increased their staff significantly within the last decade in
preparation for, and to be able to respond to the additional demand on resources created by
the MDR and IVDR. Today, most NBs have capacity to accept applications and undertake
conformity assessment activities quickly for most types of devices with some capacity
restrictions for a limited number of device types. However, some NBs are facing difficulties
in planning of their work and keeping their resources occupied due to delays in technical
documentation submissions by manufacturers and in receiving responses to questions raised
during the conformity assessment process…
