Software as a medical device is a concept previously unregulated until recently. We are all familar with IDE (Investigative Device Exemption) as it applies to hardware, or biological implants.
Software intended to be used for one or more
medical purposes that perform these purposes
without being part of a hardware medical device
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical devices.
• SaMD is capable of running on general purpose (non-medical purpose)
• “without being part of” means software not necessary for a hardware medical
device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to
drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products
including medical devices;
• SaMD may be interfaced with other medical devices, including hardware
medical devices and other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD.
The document herein was produced by the International Medical Device Regulators Forum
(IMDRF), a voluntary group of medical device regulators from around the world. The document
has been subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution or use of this document; however,
incorporation of this document, in part or in whole, into any other document, or its translation
into languages other than English, does not convey or represent an endorsement of any kind by
the International Medical Device Regulators Forum.
The road to the use of software as a medical device is still new, especially to those directed to consumers or sold as B2C.
The link here will take you to the International Medical Device Regulators Forum