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  • Regulatory NewsRegulatory News

    Shortfall of IVDR-Designated Notified Bodies a Real Possibility

    In vitro diagnostic (IVD) manufacturers face a major regulatory leap as the new In Vitro Diagnostics Regulation (IVDR) takes hold, with many products requiring notified body oversight for the first time. Early indications suggest the number of notified bodies designated to the IVDR could fall short of demand.   In a recent member survey by Team-NB, just 11 organizations said they plan to apply for IVDR status, about half the number designating to the Medical Device R...