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The European market for medical devices faces challenges due to the Medical Device Regulation (MDR), which sets higher standards for manufacturers, importers, and distributors. This tutorial aims to help understand the European legal framework and steps necessary before selling devices in the European community. The video includes a checklist to ensure regulatory compliance, preventing delays and facilitating faster market entry. Kazan Yuna, owner of Yuna Institute, a German consultancy firm, and their team provide support in quality management systems, technical file compilation, and usability testing for medical device manufacturers.
