Skip to content Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example! Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management. Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own. 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. Delegated acts and implementing acts are instruments of the European Commission to ensure the implementation of the EU MDR. Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.