Along with the MDR, more stringent requirements are introduced for Economic operators involved in the distribution of medical devices to the European market. On December 1, 2020 the actor registration module of EUDAMED has been made available.
Introduction from white paper:
The European Medical Device Regulation (MDR) has brought the responsibilities of Economic Operators into focus, and adds new requirements for all actors in the medical device supply chain. In this white paper, the first in a series of papers co-authored by Clarvin, Devicia, Kickfile and Morris Law, an overview of the requirements for each of the different actors defined as Economic Operators will be provided. The most significant changes for Economic Operators when transitioning from the Medical Device Directive (MDD) to the MDR are highlighted.
Are you ready? Read our white paper to find out more!