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International Medical Device Regulatory Monitor
October 2012 | Vol. 20 No. 10
EC Proposes Risk-Based Classification System for IVD Medical Devices
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 place new requirements on the majority of current Class A IVDs by bumping them up to Class B.
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