Home > Newsletters > Devices & Diagnostics Letter > EC Would Align IVD Classifications With GHTF’s Risk-Based Approach
Devices & Diagnostics Letter
Oct. 1, 2012 | Vol. 39 No. 39
EC Would Align IVD Classifications With GHTF’s Risk-Based Approach
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.
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