Skip to content 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 GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices. Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).