Survey on applications by the Team-NB member notified bodies under the MDR/IVDR and how this compares with their current scope under the three current directives AIMDD/MDD/IVDD.
GAMETIME FOR NOTIFIED BODIES: This Sunday, the starting gun fires for the Continent’s notified bodies. (We never tire of using the relay race metaphor to describe implementing the EU’s new complex, multi-stage medical device regulations.) It’s the first day bodies can apply with national authorities to keep doing their job of assessing the quality and [...]
Team-NB welcomes a new member from Italy : Ente Certificazione Macchine Srl. (NB 1282). From now on, the association has 24 members from 12 different countries.
84% intended to submit their application in November, 8% in December and 8% next year.
The meeting is held in two parts. The first part is a meeting with representatives of Notified Bodies only and the second part of the meeting will take place with representatives of Notified Bodies, of the Industry association and from European Commission.