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.
In Jyske Bank’s eyes, Genmab’s newest cancer candidate is almost certain to be approved, though the bank says stock increases in the past year have reduced the upside potential for the Danish biotech firm.
The US retail chain has stopped selling its own private label hearing aids – and until the next generation comes along, other hearing companies selling products via Costco are enjoying the empty shelf space.