IMDRF final document setting out a common definition of SaMD and a reminder of related key terms. SaMD is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device, and the document converges on the term SaMD in place of terms such as "standalone software." Notes to the definition state that SaMD is a medical device and includes IVD medical devices; that it is capable of running on general purpose (non-medical purpose) computing platforms; that "without being part of" means the software is not necessary for a hardware medical device to achieve its intended medical purpose; that software intended to drive a hardware medical device does not meet the definition; that SaMD may be used in combination with (e.g., as a module) or interfaced with other products, including medical devices; and that mobile apps meeting the definition are SaMD. Software used to make or maintain a device is not considered SaMD. Relevant key terms previously defined in GHTF documents are also restated.