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Home » ENVI Moves IVD Regulation to Plenary; Industry Balks at Three-Year Transition
ENVI Moves IVD Regulation to Plenary; Industry Balks at Three-Year Transition
September 27, 2013
In vitro diagnostic devicemakers say they will need at least five years to collect and submit additional supportive clinical data on the products, two more than proposed in regulations adopted by the EU Parliament’s health committee Sept. 25.