Team-NB hve published a press release “TEAM-NB Notified Bodies call to action to manufacturers to apply. October 2023″
This press release is a call to action to to apply with notified bodies in time especially for high-risk IVD medical devices. It intends to raise awareness with the device manufacturers and other economic operators to apply with notified bodies in time. The survey referred to above, also showed that the initial conformity assessment process may take 6-12 months for low to medium risk devices (covered by quality annex certificates) and between 13-18 months for high-risk devices (covered by a product annex certificate).