The Medical Device Coordination Group: a new Authority Under EU Device Regulations
By Robert D. Cumming, Nancy W. Mathewson, Esq. -
Published 14 November 2017
This article discusses the organization and functions of the Medical Device Coordination Group (MDCG) established under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The article explains how both groups will be important players in the conformity assessment body 'notification' process and in determining how notified bodies assess and certify devices and in serving as a reviewing body for making regulatory and jurisdictional decisions for the European Commission.
Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices
Tags: MDR, IVDR, Medical Device Coordination Group, MDCG