For manufacturers of legacy Class C IVDs that were self-declared under the EU IVDD, 26 September 2026 is one of the most important dates of…
Team-NB issues recommendations on the classification of SARS-CoV-2 IVDs
Team-NB, the European Association of Medical Devices Notified Bodies, has released a position paper providing recommendations for manufacturers of IVDs intended to detect the presence or the…