This document specifies the clinical evaluation framework for SaMD, defining a three-layer structure for evidence of effectiveness: analytical validation, technical verification, and clinical validation. Manufacturers should determine the depth of clinical evidence required based on the SaMD risk category established in the N12 framework. The document provides guidance on what constitutes appropriate clinical evidence for each risk level and serves as the baseline for clinical evaluation requirements in regulatory submissions. This framework is referenced in FDA, PMDA, and EU MDCG approval processes, establishing harmonized expectations for clinical documentation and evidence standards in SaMD regulatory submissions globally.

This core document defines the risk classification framework for SaMD using a two-axis matrix approach. The framework combines clinical context (serious condition, significant condition, or minor condition) with the significance of information provided by the SaMD (treatment, diagnosis, or notification), resulting in four risk categories. This classification scheme provides the basis for regulatory decision-making regarding appropriate oversight levels. The framework is referenced internationally in Japan's Program Medical Device classification system, FDA Digital Health Policy, and EU MDR risk assessment requirements, establishing a harmonized foundation for SaMD regulatory evaluation across multiple jurisdictions.

This foundational document establishes international definitions and terminology for Software as a Medical Device (SaMD), distinguishing it from hardware-based medical devices. SaMD is defined as software intended for use in achieving a medical purpose without being part of a hardware medical device. This definition serves as the baseline reference for all subsequent IMDRF SaMD guidance documents and national regulatory frameworks. The FDA, PMDA, and EU MDR all reference this definition in their respective SaMD regulatory frameworks, making it essential to understanding harmonized international SaMD regulation and classification schemes adopted globally.