European Commission Issues EU MDR/IDVR Implementation Plan

The European Commission issued a new work plan for implementation of EU regulations on medical devices and in vitro diagnostics.

The plan outlines the status and projected timelines for 12 implementing acts for the EU's Medical Devices Regulation and In Vitro Diagnostics Regulation as well as 12 other initiatives. The first implementing act was completed last November, defining the scope of notified body designations, which the Commission described as essential for the launch of the NB designation procedure.

According to the working plan, 33 NB designation applications were received as of mid-September and 22 joint assessments have been scheduled.