TEAM NB Position Paper on Orphan under the IVDR V1
The position paper includes a proposal for a definition of an orphan IVD and for an approach to conformity assessment for this type of devices. The paper was developed taking into account [...]
Tenth session : MDR Technical Documentation Training for Manufacturers
TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on September 17th, 2025. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining [...]
TEAM NB Position Paper on Software qualification under the IVDR V2
The “IVD Software Working” Task Force members who represented 15 members drafted an updated 2nd version of a position paper addressing Software qualification under the IVDR. The decision tree was simplified and [...]
Team-NB at European Parliament
Team-NB representatives met with a MEP responsible for the SANT committee to present the work carried out by the NB with one of the objectives of guaranteeing patient safety. [...]
TEAM-NB
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