Software as a medical device (SaMD)

SaMD is the IMDRF term, used by the FDA and many other regulators. The FDA describes it as one of three types of software related to devices, next to software that is integral to a device and software used to manufacture or maintain a device. Being SaMD says nothing about risk; the class depends on what the software is intended to do.

The term Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

FDA: Software as a Medical Device (SaMD) (web page, content current as of 12/04/2018), quoting IMDRF, What is Software as a Medical Device?

The EU MDR uses the broader term medical device software (MDSW), which also covers software that drives or influences a hardware device, and Rule 11 is central to classifying it. The FDA reviews software by device software function, so one product can have device and non-device functions.