Skip to content Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards. The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline! 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. Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.