SaMD

Software as a Medical Device

SaMD 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.” A diagnostic algorithm that runs on a general-purpose phone or in the cloud is SaMD; the firmware that drives an infusion pump is not (that is software *in* a device, or SiMD). Many AI/ML clinical tools fall squarely in the SaMD category.

IMDRF frames SaMD risk by combining the significance of the information it provides (inform → drive → treat/diagnose) with the seriousness of the healthcare situation (non-serious → serious → critical). Regulators map that risk to their own classifications — the FDA under its device authorities and digital-health program, and the EU under the MDR/IVDR, where software is classified via Rule 11. The development lifecycle is governed by IEC 62304, with risk management under ISO 14971 and a quality system under ISO 13485 / the FDA QMSR.

• —SaMD vs SiMD — SaMD performs its medical purpose on its own; software embedded in a hardware device is not SaMD.
• —IMDRF risk framework — significance of information × seriousness of the healthcare situation → four risk categories (I–IV).
• —Lifecycle standard — IEC 62304 (software lifecycle), with ISO 14971 (risk) and ISO 13485 / FDA QMSR (quality system).
• —Regulatory routes — FDA device pathways / digital-health program; EU MDR/IVDR software classification (Rule 11).

IMDRF SaMD framework (definitions, risk categorisation, clinical evaluation); IEC 62304; ISO 14971; EU MDR 2017/745 (Rule 11); FDA digital-health / Software as a Medical Device program.