Both 1st sessions are fully booked, TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on February 7th , 2024. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
This press release is a call to action to apply with notified bodies in time especially for high-risk IVD medical devices. Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023
All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place on October 17th to 19th. These meetings will take place remotely.
Following the November 7th session is fully booked, TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on December 14th. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
The Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR is available on the Commission website on Medical Devices md_new-reg_annex-xvi_q-n-a_transition-prov
A training dedicated to help manufacturers to clarify the MDR Technical Documentation requirements is planned on November 7th. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
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 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 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
The attached press release is presenting the outputs of the 1st training session.PressRelease-Training-for-IVD-manufcaturers-20230706
