IVDR Technical Documentation training
The 2nd session of this training dedicated to manufacturers is fully booked since June. It will take place 1st week of September. A 3rd session date will be communicated shortly.
Team-NB PP Transfer Agreement for Surveillance of Legacy Devices
Team-NB members adopted a template agreement specifying the terms of the transfer of the surveillance according to Regulation 2017/7451 for legacy devices. Team-NB-PositionPaper-TransferAgreement-V1-20230811
TEAM-NB Position Paper on New MDR Transition Timelines and Notified Body Capacity
Team-NB members specify in this paper their views on the amended timelines with regards to benefits for the European patients and as the continuity in the availability of essential medical devices in the European market.Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1
Team-NB welcomes a new member from Italy :
MTIC (NB 0068). From now on, the association has 30 members from 18 different countries.
MCDG-Med meetings
All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place remotely on April 5 to 7th.
Team-NB welcomes a new member from Poland :
PCBC (NB 1434). From now on, the association has 29 members from 18 different countries.
SNITEM Symposium
The French MD association is organising a symposium on March 14th and requested Team-NB representative to inform the audience on the NBs views regarding new regulations implementation