The press release is presenting the outcomes of the course and the progress of the manufacturers towards their transition to MDR thanks to responses of the attendants. Info on the 1st MDR training session : PressRelease-Training-for-MD-manufacturers-20231123

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

The attached press release is presenting the outputs of the 1st training session.PressRelease-Training-for-IVD-manufcaturers-20230706

The summary of references of harmonised European standards is published in the Official Journal of the European Union in reference to Regulation (EU) 2017/745 on medical devices.Summary hENs MDR 7-2023

The act is applicable from today and has been published on the Official Journal of the European Union.