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 Position Paper on MDR Application and appropriate surveillance Transfer agreement
Team-NB members adopted during the General Assembly meeting, at the unanimity of the NBs presents, a template Agreement form RELATED TO THE TRANSFER OF MDR FORMAL APPLICATION AND OF APPROPRIATE SURVEILLANCE OF [...]
TEAM-NB
25 YEARS
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