Innovation is everywhere, including in the medical world. Increasingly, software is being used in e.g. diagnosis, treatment, prognosis and relief of an illness or disability. As a result, software is increasingly classified as a medical device. This means that medical device rules must be applied to new technologies, such as artificial intelligence, virtual/augmented reality and other types of software applications. How to determine whether software is a medical device under the European Medical Devices Regulation (MDR)? This requires going through 5 simple questions.