Time To Address Root Causes Of IVDR Notified Body Capacity Shortfall, Commission Says

The European Commission has injected an increased sense of urgency into its updated IVDR implementation plan and is creating a feedback loop to help direct resources where most needed.

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A lack of notified body capacity could lead to shortages and supply disruptions of critical IVDs during the implementation of the In Vitro Diagnostic Regulation (IVDR), the European Commission’s Directorate General for Health and Food Safety, which oversees the regulation of medtech, has admitted.

In its just-updated Joint Implementation And Preparedness Plan for the IVDR, the commission says recent industry and notified bodies...