New regulation means stricter requirements for medtech firms

On Wednesday, new regulations for medtech equipment came into force in the EU. The regulations increase patient safety while complicating matters for medtech companies that sell products on the European market. An industry association criticizes the lead-up.

BY MIKKEL AABENHUS HEMMINGSEN, ALBERT RØNNING-ANDERSSON AND ULRICH QUISTGAARD, TRANSLATED BY NIELSINE NIELSEN

Starting Wednesday, medtech companies will need to live up to a new set of requirements if they plan on selling their equipment on the EU market.

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