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Home » EC Would Align IVD Classifications With GHTF’s Risk-Based Approach
EC Would Align IVD Classifications With GHTF’s Risk-Based Approach
September 28, 2012
A newly proposed EU regulation on in vitro diagnostic medical devices seeks to align IVD classification with the Global Harmonization Task Force’s risk-based model — a move that could bump a majority of current Class A IVDs into Class B.