A regulação de softwares como dispositivos médicos em perspectiva comparada: Brasil e União Europeia

The healthcare field has witnessed a true digital revolution in recent years, with the widespread introduction of software and applications to assist in therapeutic decision-making and self-management of users’ health. Thus, the category of software as a medical device (SaMD) was created with a differentiated regulation due to the increased risks that these devices present to the population. This article aimed to analyze the recent regulation approved on the subject of SaMD in Brazil and the European texts that served as inspiration. It sought to verify the positive points and possible regulatory challenges to be faced according to the future development of this market, especially when considering the incorporation of ar tificial intelligence technologies into the applications used.