Health Technology Assessment Stakeholder Network
Team-NB has been appointed to the network in the framework of the HTA regulation implementation.
“Team-NB views on implementation of MDR/IVDR Regulations” Press Release
Attached the press release on Team-NB views. PressRelease-Team-NB-20241024
MD newsletter
October 2024 “MEDICAL DEVICES NEWS” issued by DG Santé is out now. You can reach it thanks to the link https://ec.europa.eu/newsroom/sante/newsletter-archives/56793
Team-PRRC 3rd summit – Day 2
Team-NB representatives at TEAM-PRRC summit (day 2) round table.
Team-PRRC 3rd summit
Team-NB is taking part as speaker at the summit.
Seventh session : MDR Technical Documentation Training for Manufacturers
TEAM-NB set up a date for the MDR technical documentation training for manufacturers on November 06th , 2024. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
“Implementation of Class D oversight by EURLs” Press Release
1st October 2024 marks the transition to operations for EURLs for Class D IVD. NBs will continue collaborating with all stakeholders to ensure a smooth transition to operations. PressRelease-ClassD-20241001
MDCG 2021-4 Rev 1
The Commission published a revision of transitional provisions for certification of class D in vitro diagnostic medical devices containing clarifications on EURL operations. mdcg_2021-4_en
NBCG-Med meetings
All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place on October 8th to 10th. These meetings will take place remotely.
Code of conduct – version 5
This new version adopted by electronic mechanism is available Team-NB Documents. A press release is attached. PressRelease-CoC-20240916