Discover the critical changes coming with the MDR Reform at Year-End that aim to enhance patient safety and streamline compliance. Key revisions will focus on reducing administrative burdens, improving certification predictability, and fostering international cooperation. Will these changes restore the EU's appeal as a hub for innovative medical devices?

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By 2025, medical device importers and distributors will face one of the most significant regulatory shifts in decades. The European Union's MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) deadlines are closing in, while the U.S.

QMSR wird das Qualitätsmanagementsystem für Medizinprodukte der FDA an ISO 13485:2016 anpassen. Es wird bis Ende dieses Jahres veröffentlicht und tritt ein Jahr später in Kraft. Es wird erwartet, dass diese Harmonisierung den Medizintechnikunternehmen in den nächsten zehn Jahren mindestens 439 Millionen US-Dollar einsparen wird.