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    Implementation of IVDR and MDR Into National Legislation

    This article discusses current revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in the European Union (EU). The authors use an example from Germany’s experience and efforts to examine revisions from an implementation perspective. The impact of this new regulatory environment and associated challenges for medical device and in vitro diagnostic device manufacturers are discussed as well as hurdles and “bottlenecks” that could m...