{"id":4410,"date":"2026-08-13T20:10:11","date_gmt":"2026-08-13T20:10:11","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=4410"},"modified":"2026-08-13T20:10:11","modified_gmt":"2026-08-13T20:10:11","slug":"samd-classification-strategy-how-medical-device-manufacturers-should-approach-software-risk","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/samd-classification-strategy-how-medical-device-manufacturers-should-approach-software-risk\/","title":{"rendered":"SaMD Classification Strategy: How Medical Device Manufacturers Should Approach Software Risk"},"content":{"rendered":"

Software as a Medical Device (SaMD) has become one of the most dynamic areas of medical device regulation. For manufacturers, one of the first questions is not only whether the software is a medical device,\u00a0but also how it should be classified from both a regulatory and risk management perspective.<\/span>\u00a0<\/span><\/p>\n

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Classification is not simply an administrative exercise. The regulatory class assigned to a software product may influence market access pathways, evidence requirements, quality management expectations, software lifecycle activities, and post-market obligations. At the same time, manufacturers must recognize that regulatory classification is only one part of a broader risk-based strategy.<\/span>\u00a0<\/span><\/p>\n

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This article focuses on the strategic considerations manufacturers should evaluate when developing a classification approach for software-based medical technologies.<\/span>\u00a0<\/span><\/p>\n

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Why Does SaMD Classification Matter?<\/span><\/b>\u00a0<\/span><\/h3>\n

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SaMD classification is one of the first regulatory decisions that can affect the development and commercialization strategy of a software product. The classification may\u00a0determine\u00a0the applicable regulatory pathway, documentation requirements, quality management expectations, evidence needed to support safety and effectiveness, and the timeline to market.\u00a0<\/span>\u00a0<\/span><\/p>\n

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For manufacturers, classification should not be treated as an isolated regulatory step. It should be connected to intended use, clinical evaluation, risk management, software lifecycle activities, cybersecurity controls, and post-market monitoring.<\/span>\u00a0<\/span><\/p>\n

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A common mistake is assuming that a classification in one framework automatically\u00a0determines\u00a0the classification in another. For example, a software safety class under IEC 62304 does not directly equal the regulatory class under FDA,\u00a0COFEPRIS,\u00a0INVIMA, or another jurisdictional framework.\u00a0While both systems consider patient harm, they serve different purposes and should be evaluated independently.<\/span>\u00a0<\/span><\/p>\n

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Step 1: Define the SaMD Intended Use<\/span><\/b>\u00a0<\/span><\/h3>\n

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Before assigning any class, manufacturers should clearly define the intended use of the software. This includes the medical purpose, the intended user, the patient population, the\u00a0disease\u00a0or condition involved, the software inputs, the software outputs, and how those outputs will be used.<\/span>\u00a0<\/span><\/p>\n

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The intended use helps\u00a0determine\u00a0whether the software is intended to diagnose, treat, monitor, mitigate, predict, or provide information for clinical decisions. It also helps\u00a0determine\u00a0whether the software output is merely informative or whether it may influence a therapeutic or diagnostic decision.<\/span>\u00a0<\/span><\/p>\n

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For example, software that only stores or transfers information may have a different regulatory profile than software that analyzes patient data and recommends a diagnostic or therapeutic action. Similarly, software used by a trained healthcare professional may raise different considerations than software intended for use by patients or caregivers.<\/span>\u00a0<\/span><\/p>\n

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The intended use also serves as the foundation for risk management activities, clinical evaluation strategies, and classification assessments.<\/span>\u00a0<\/span><\/p>\n

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This is also relevant in Mexico. In our\u00a0<\/span>Guide\u00a0on the classification of Software as a Medical Device in Mexico<\/span><\/a>, we explain that the intended use is fundamental to\u00a0determine\u00a0whether software is considered SaMD and how it may be classified\u00a0by COFEPRIS.\u00a0<\/span>\u00a0<\/span><\/p>\n

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IMDRF SaMD Categorization<\/span><\/b>\u00a0<\/span><\/h3>\n

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The International Medical Device Regulators Forum (IMDRF)\u00a0has developed a widely recognized framework that helps manufacturers understand the potential risk associated with Software as a Medical Device.<\/a><\/span>\u00a0<\/span><\/p>\n

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The framework\u00a0evaluates\u00a0two main factors:<\/span>\u00a0<\/span><\/p>\n

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  1. The significance of the information provided by the SaMD to the healthcare decision<\/span>\u00a0<\/span><\/li>\n
  2. The state of the healthcare situation or condition<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

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    The significance of the information can\u00a0generally be\u00a0understood according to whether the software is intended to:<\/span>\u00a0<\/span><\/p>\n