Europe – 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 manufacturers are projected and hurdles and “bottlenecks” that may prevent full implementation or make full implementation difficult are discussed.

Background

Since 26 May 2017 when the new In Vitro Diagnostics Regulation (IVDR) and Medical Devices Regulation (MDR) came into effect in the European Union (EU) and implementation became required through EU member state national legislation, the German Federal Ministry of Health initiated National Working Groups (NAKI) for the process of implementation. However, regulatory implementation efforts on the national implementation of IVDR1 and MDR2 are facing several “bottlenecks.” These regulatory bottlenecks include problems with the European database on medical devices (EUDAMED), which is not fully operational, the reduced number of Notified Body (NB) for applicants which results in a reduced number of designated NBs for review of MDRs and IVDRs, and new, stricter classification rules for these devices…