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BioWorld - Thursday, January 1, 2026
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Home » Team NB proposes conditional CE marks for MDR, IVDR
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Team NB proposes conditional CE marks for MDR, IVDR

March 14, 2025
By Mark McCarty
The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.
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