Software as a Medical Device

Mi3 News

Software classification has changed with the MDR, there is now a rule (Annex VIII, Rule 11: Classification of Software as a Medical Device (SaMD)) that has categorised different types of software from classes I to III1.

Technology continues to advance all facets of health care with the Internet of Medical Things (IoMT), wearables, AI and more, and so software becomes an important part of all products integrated widely into digital platforms with both medical and non-medical purposes. This is continuously influencing how healthcare is delivered and also the use of highly sophisticated software fulfils requirements2,3. The types of software relating to medical devices are, software that is integral to a device (SiMD) that is part of the device such as AI, software used to manufacture or maintain a device (Usual Purpose Software), software as a medical device (SaMD), that is complete software that serves as the device itself, and software as an accessory to a medical device3.

Thinking about SaMD, the International Medical Device Regulators Forum (IMDRF) defines the term Software as a Medical Device as “a software designed in a way to be used for the operation of one or more medical purposes that perform these functions without being part of a hardware or medical device”4, and this is the main advantage of SaMD.

Other advantages of SaMD include collection of huge data sets including user feedback because of availability across multiple devices. This leads to quicker feedback and therefore quicker innovation and market access; if the data collection is accurate! Also, leveraging connectivity and technology to other people and devices that can continuously diagnose, monitor, alert and communicate condition management – but again, this must be accurate and risks designed out at the design stages3.

Risks in SaMD can be established and addressed during design & development and on-going throughout lifecycle through the use of ISO 14971 and IEC 62304, and the SaMD must comply with the requirements of the latter5. Often software manufacturers fail to recognise IEC 623045 and this along with other procedures are essential to be defined upfront.



  1. MDR (EU)2017/745


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