Skip to content The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes. Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going. The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period. Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).