MedWatch

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.

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.

Following a one-year postponement due to the covid-19 crisis, an EU medtech order known as the medical device regulation (MDR) is now being implemented. This will introduce stricter demands for clinical trials involving new products and documented proof that rules are being upheld.

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