Software as a medical device
Short definition
Software as a medical device is software that, on its own, has a medical purpose assigned by the manufacturer and is therefore regulated as a medical device.
In plain language
Under Regulation (EU) 2017/745, software is expressly included in the definition of a medical device and is classified mainly under Rule 11 of Annex VIII. Broadly, software that provides information for diagnostic or therapeutic decisions, or that monitors physiological processes, falls into higher classes, and all other software with a medical purpose is Class I. The European coordination group (MDCG) has published its own guidance on the qualification and classification of software, MDCG 2019-11.
In practice, in an RVer session
RVer AI ranks the library and shows the evidence behind each suggestion, but it does not diagnose or prescribe: the decision rests with the team.