August 2023
Team-NB PP Transfer Agreement for Surveillance of Legacy Devices
Team-NB members adopted a template agreement specifying the terms of [...]
TEAM-NB Position Paper on New MDR Transition Timelines and Notified Body Capacity
Team-NB members specify in this paper their views on the [...]
July 2023
IVDR Technical Documentation Training for Manufacturers
The attached press release is presenting the outputs of the [...]
Harmonised standards MDR – published in the OJEU
The summary of references of harmonised European standards is published [...]
June 2023
New candidate member : ICR Polska
Team-NB welcomes a new Canditate member from Poland, as the [...]
Commission Implementing Regulation (EU) 2023/1194 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
The act is applicable from today and has been published [...]
IVDR Technical Documentation Training for Manufacturers – 2nd session
The 2nd session scheduled for September 7th is also complete. [...]
May 2023
NBCG-Med webpage
The Commission published the « Template notified body confirmation letter [...]
Team-NB PositionPaper on HybridAudits-V2
After some updates taking into consideration some remarks and in [...]
Guidance on significant changes
The revision 1 of the MDCG 2020-3 regarding the transitional [...]