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 [...]
Team-NB Position Paper on BPG Technical Documentation
During Team-NB General Assembly Meeting, all the members presents voted [...]
Team-NB Position Paper on Transfer Agreement
Team-NB voted to approve this paper. Some of NBs intend [...]
September 2022
Team-NB Position Paper on time to implement guidances
Thanks to the work of the MDR&Covid task force, Team-NB [...]
HCWH webinar on Safer medical devices: Implementation of the EU MDR and EUDAMED database.
HealthCare Without Harm association held his webinar on the topics [...]
New-Member : Certiquality-NB0546
Team-NB welcomes a new member from Italy. From now on, [...]
Team-NB Position Paper on Hybrid Audit
Thanks to the work of the MDR&Covid task force, Team-NB [...]