Designation of Notified Bodies: State of Play

The designation process of Notified Bodies against both medical devices regulations, namely MDR 745-2017 and IVDR 746-2017 is a long process. The process began 6 months after the new regulations publication, on November 26th, 2017 with the 1st possible date for notified bodies to apply to be designated.

After the application, the designation process itself began with an estimate duration of 18 months. On May 27, 2019, only 2 notified body were designated against MDR 745-2017.

To answer the transparency request of the sector concerning the capacities of notified bodies to meet the sector needs, the Team-NB association as well as the NB-Med group made surveys at different dates to have an overview of the progress of the notified bodies in the designation process against the 2 regulations. 

The presentation will allow you to know the most recent data on the on-going designation process.