Team-NB Position Paper on Annex VII – Implementing Regulation Draft
Team-NB welcomes the Commission’s efforts to improve the regulatory framework and acknowledges the potential benefits of clear timelines. That said, NBs have identified several challenges and risks associated with the proposal, such [...]
TEAM NB Position Paper on SARS-CoV-2 test down-classification V1
The IVD designated NBs endorsed a paper on Considerations for conformity assessments Done by NBs in the case of down classification of SARS-CoV-2 tests, including operational aspects and Q&A parts. Team-NB-PositionPaper-IVD-SARS-CoV-2-down-classification-V1-20251212 [...]
New session : MDR Clinical Training for Manufacturers
TEAM-NB set up a new ½ day training for manufacturers dedicated to clinical aspects. It is planned on February 26th afternoon. More info available in the leaflet thanks to a click: Leaflet-MDR-Clinical-Manufacturers-Training-20260226 [...]
MEDICA – CEO roundtable by EUROM/SPECTARIS in the presence of Commissioner Várhelyi
Two representatives from the NB team participated in this high-level meeting. President Alexey Shiryaev was invited to take the floor to present Notified Bodies perspectives.
TEAM-NB
25 YEARS
44 MEMBERS