We have prepared an overview of the areas we consider CRITICAL in preparing for the transition from MDD to MDR. The selection is based on the following criteria: A fundamental difference between MDD and MDR with a major impact on the manufacturer/device. The difficulty of managing them is confirmed by the practical experience of our clients. They often escape attention. For clarity, we have divided these areas into "general", which apply to all manufacturers and all medical devices, and "specific", which apply only to certain device groups. The selection is, of course, taken from a subjective point of view. Nevertheless, we hope that readers will find it inspiring and particularly helpful in properly focusing resources in preparation for MDR certification.
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