ENVI Sends IVD Regulation to Plenary; Industry Balks at Three-Year Transition

In vitro diagnostic devicemakers say they will need at least five years to collect and submit additional supportive clinical data on their products, two more than proposed in regulations adopted by the EU Parliament’s health committee Sept. 25. “In order to implement this revision, manufacturers will need to produce and provide significant amounts of scientific evidence to support the efficacy of IVDs,” industry group EDMA said.
International Medical Device Regulatory Monitor