Document paper New medtech regulations

Implementation Status of the Medical Devices Regulation: a Call to Action

The MDR transition period is nearly over, however, the new regulatory system is not yet ready to support the transition of tens of thousands of lifesaving and life-transforming technologies from the old regulatory regime to the new.

The MDR provides three key ways which a manufacturer can currently use to keep a given medical device available to patients after 26 May 2020.

This document lays out the main challenges that are currently preventing manufacturers from being able to leverage these three solutions successfully, as well as concrete solutions for the attention of the EU authorities.

Posted on 08.01.2020

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