Skip to content 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. Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.