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_v02-20240702.pdf

AFNOR is becoming a full member following is newly designation against MDR in France.

The press release and the graphs with all data from the 35 members at end 2023 are available now. They are both available in the Team-NB Documents

Team-NB welcomes a new member from Italy : ICIM Spa (Notified Body N° 0425).

The European Society of Minimally Invasive Neurological Therapy issues a call for experts in neurointerventions to work with notified bodies in the certification process of medical devices within the European Union (EU).   See more info in the press release. Call-for-Experts-Press-Release_240423.docx

TEAM-NB set up a new date for the IVDR technical documentation training for manufacturers on July 3rd , 2024.   IVDR Technical Documentation Training for Manufacturers   For registration, follow the link:  ManufacturerTraining

Relaxing time after election and before 2 years of intensive work at the service of the members to ease implementation of the legislative framework for the well-being of all patients.  

As part of the NBCG-Med meetings, there was a session on April 10th with EU Reference Laboratories, Notified bodies and members of the Commission.  

Following legal requirements, the statutes were updated in presence of 95% of the members. The association is intending to be active in promoting harmonisation among its members and also continuing to help manufacturers to understand and meet the legislations to enhance patients safety.  

TÜV SÜD Danmark is becoming a full member following is newly designation against MDR in Denmark.