Skip to content Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards. Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example! Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind. 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 clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.