New session : MDR Clinical Training for Manufacturers
TEAM-NB set up a new training for manufacturers dedicated to clinical aspects. It is planned on December 16th. More info available in the leaflet thanks to a click: Leaflet-MDR-Clinical-Manufacturers-Training-20261216 For registration, follow [...]
Position Paper on Transparency in the framework of the MDR/IVDR proposed revision of the Regulations
Team-NB members endorsed a position paper on “TRANPARENCY”. It demonstrates that notified bodies access to information available in EUDAMED is crucial to allow a rapid risk-based regulatory oversight. Team-NB-PositionPaper-Transparency-V1-20260806 [...]
Transparency in the framework of the MDR/IVDR proposed revision of the Regulations
Team-NB wrote a one-pager in the framework of the proposed revision of the regulatory framework applicable to medical devices and in vitro diagnostic devices on Transparency to ensure that Notified Bodies have [...]
Risk-adapted surveillance in the framework of the MDR/IVDR proposed revision of the Regulations
Team-NB wrote a one-pager in the framework of the proposed revision of the regulatory framework applicable to medical devices and in vitro diagnostic devices on Risk-adapted surveillance, to focus scrutiny where risks [...]
TEAM-NB
25 YEARS
45 MEMBERS