December 2022
Team-NB members
To date the list of Team-NB member organisations is 34 [...]
MDCG 2022- 2021, Guidance on PSUR
The awaited Guidance on Periodic Safety Upadate Report according MDR [...]
Designation of notified bodies under the upcoming Artificial Intelligence Act
This position paper was prepared by the “AI & mobile [...]
November 2022
New-Member : SGS Fimko Ltd -NB0598
Team-NB welcomes a new member from Finland. From now on, [...]
Team-PRRC 1st summit
The summit gathered representatives from different parties - Commission, NBs, [...]
October 2022
Leveraging directive conformity assessments to establish compliance with the MDR requirements
The members meeting in general assembly gave their agreement in [...]
Data generated from ‘Off-Label’ Use of a device under the EU Medical Device Regulation 2017/745
This position paper was prepared by the Mirror-MDCG-Clinical Working group [...]
Cyber Security position paper
This paper has been prepared thanks to the task force [...]
Class D measures in the absence of EU Reference Laboratories
Thanks to the work of the IVD working group, Team-NB [...]