NAVIGATING THE COMPLEXITIES OF MDR CE MARKING: KEY CHALLENGES AND SOLUTIONS FOR MEDICAL DEVICE MANUFACTURERS

Navigating the Complexities of MDR CE Marking: Key Challenges and Solutions for Medical Device Manufacturers

The transition to the Medical Device Regulation (MDR) has introduced several challenges for medical device manufacturers, particularly when it comes to obtaining the CE Marking required for market access in the European Union. The MDR imposes stricter requirements than the previous Medical Devices Directive (MDD), making it essential for manufactur

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