• Feature ArticlesFeature Articles

    CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation

    This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system. 1 The regulations, intended to affect greater IVD saf...
  • Feature ArticlesFeature Articles

    The Medical Device Coordination Group: a new Authority Under EU Device Regulations

    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 jurisdi...