Skip to content 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. Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).