In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses the application of transitional provisions for certification of class D…
Public consultation on common specifications for IVDs
From 19 August 2024, the European Commission opened a public consultation on common specifications for certain vitro diagnostic medical devices. For four weeks, until 16…
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…
NB Position Papers on Class D devices in absence of EURLs and time to implement guidance documents
Between September and October 2022, Team-NB published various position papers. One of them addresses class D devices and their conformity assessment in absence of EU…
Class D IVDR: Clarification on “first certification for that type of device” by MDCG
The MDCG has endorsed a guidance (updated September 2022) providing clarification on the conditions and corresponding procedures notified bodies need to apply when determining if an expert panel consultation on…