{"id":1818,"date":"2021-05-13T17:06:03","date_gmt":"2021-05-13T17:06:03","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1818"},"modified":"2026-08-12T22:06:32","modified_gmt":"2026-08-12T22:06:32","slug":"software-as-a-medical-device-usa-europe-canada-and-mexico-cases","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/software-as-a-medical-device-usa-europe-canada-and-mexico-cases\/","title":{"rendered":"Software as a Medical Device (USA, Europe, Canada and Mexico cases)"},"content":{"rendered":"

Technological advances in health care have positioned software as an essential\u00a0component\u00a0of products and services for the diagnosis and analysis of clinical conditions and diseases.\u00a0Although software has traditionally been included as part of medical devices, in recent years there has been an increased use of software as a medical device on its own.\u00a0This situation has promoted the regulation of Software as a Medical Device (SaMD) by\u00a0several\u00a0regulatory agencies.<\/span>\u00a0<\/span><\/p>\n

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IMDRF Definition and Risk Framework for Software as a Medical Device<\/span><\/b>\u00a0<\/span><\/h3>\n

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In 2013 the\u00a0<\/span>International Medical Device Regulators Forum<\/span><\/a>\u00a0(IMDRF) SaMD Working Group issued a\u00a0<\/span>document<\/span><\/a> called <\/span>Software as a Medical Device (SaMD): Key Definitions<\/em>\u00a0with the aim of creating a common definition for the software when it is considered a medical device.<\/span>\u00a0<\/span><\/p>\n

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According to point 5.0 of the above-mentioned\u00a0document, the term \u201cSoftware as a Medical Device\u201d<\/strong> (SaMD) is defined as:\u00a0<\/span>software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device<\/span><\/i><\/b>.<\/span>\u00a0<\/span><\/p>\n

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Later in 2014, the IMDRF issued\u00a0<\/span>another document<\/span> called\u00a0<\/span>Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations\u00a0 <\/a><\/em>with the\u00a0objective\u00a0of introducing a harmonized vocabulary and considerations for manufacturers, regulators, and users of SaMD.<\/span>\u00a0<\/span><\/p>\n

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On\u00a0January 2021, the IMDRF IVD Working group released the\u00a0<\/span>document<\/span> titled Principles of In Vitro Diagnostic (IVD) Medical Devices Classification<\/em><\/a>, in which SaMD is considered when it is used to process the output from an IVD Medical Device.<\/span>\u00a0<\/span><\/p>\n

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Lastly, in January 2025, the IMDRF SaMD Working Group issued the final document\u00a0<\/span>Characterization Considerations for Medical Device Software and Software-Specific Risk.<\/a><\/em>\u00a0This document builds on the\u00a0previous\u00a0SaMD concepts by providing considerations for the characterization of medical device software and software-specific risk. It is not intended to replace the 2014 IMDRF risk categorization framework, but to supplement it with\u00a0additional\u00a0considerations applicable to a broader scope of medical device software, including software that meets the definition of SaMD.\u00a0<\/span>
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The 2025 IMDRF document highlights the importance of describing the intended use or intended purpose, software\u00a0inputs\u00a0and outputs, intended users, use environment, degree of autonomy, explainability, and change management characteristics. These elements may support risk assessment, regulatory decision-making, and the determination of device risk classifications according to each\u00a0jurisdiction\u2019s\u00a0regulations<\/span>\u00a0<\/span><\/p>\n

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These documents have been considered by IMDRF medical devices members as a basis for developing\u00a0their\u00a0own regulations, risk classification\u00a0schemes,\u00a0and\u00a0requirements.<\/span>\u00a0<\/span><\/p>\n

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Mexico SaMD Regulation: COFEPRIS, Mexican Pharmacopoeia, and NOM-241-SSA1-2025<\/span><\/b>\u00a0<\/span><\/h3>\n

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There has been a significant development in the Mexican regulatory framework concerning SaMD. An update was made to\u00a0<\/span>one of the supplements of the Mexican Pharmacopoeia<\/span><\/a>, which was published on the Official Journal of the Federation on May 5, 2023. This update marked the first official stance\u00a0regarding\u00a0Software as a Medical Device taken by Mexico.<\/span>\u00a0<\/span><\/p>\n

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The latest edition of the Supplement for Medical Devices, Fifth Edition, of the Mexican Pharmacopoeia, ratifies the inclusion of SaMD as a category within Medical Devices: an instrument, apparatus, utensil, machine, including\u00a0<\/span>software<\/span><\/b>\u00a0for its operation, implantable product or material, diagnostic agent, material, substance, or similar product, to be used alone or in combination, directly or indirectly, in human beings for medical purposes.<\/span>\u00a0<\/span><\/p>\n

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Furthermore, the update provides a specific definition for SaMD:<\/span>\u00a0<\/span><\/p>\n

\u201cSoftware as a Medical Device (SaMD) refers to software used\u00a0with\u00a0one or more medical purposes, characterized by the fact that it does not need to be part of the hardware of a medical device to fulfill its intended medical purpose.\u00a0SaMD is capable of functioning on general computerized platforms and can be used independently or in combination with other products (e.g., as a module, with another medical device, etc.).\u00a0Mobile apps that fit within this definition are also considered SaMD. Software that\u00a0facilitates\u00a0the functioning of a medical device is excluded from this definition.\u201d<\/span><\/i>\u00a0<\/span><\/p>\n

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In addition, a new rule for classifying medical devices has been implemented to address SaMD. Its classification criteria are based on the software\u2019s involvement with a patient, and whether it is critical to the patient\u2019s health condition or parameter determination. The classification for\u00a0SaMD\u00a0can range from class I to III, depending on the specifications outlined in this rule.<\/span>\u00a0<\/span><\/p>\n

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In 2025,\u00a0<\/span>NOM-241-SSA1-2025, related to Good Manufacturing Practices for Medical Devices<\/span><\/a>, also incorporated the term\u00a0<\/span>SaMD (ScDM\u00a0in Spanish)<\/span><\/i>. According to this standard, SaMD refers to software used\u00a0with\u00a0one or more medical purposes, characterized by the fact that it does not need to be part of the hardware of a medical device to fulfill its intended medical purpose. It\u00a0is capable of functioning\u00a0on general computerized platforms and may be used independently or in combination with other products, such as modules or other medical devices. Mobile applications that meet this definition are also considered SaMD, while software that\u00a0operates\u00a0a physical medical device is excluded from this definition.<\/span>\u00a0<\/span><\/p>\n

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NOM-241-SSA1-2025 also notes that SaMD may provide means and suggestions to mitigate a disease; provide information to determine compatibility, detection, diagnosis, monitoring, or treatment of physiological conditions, health states, diseases, or congenital deformities; and serve as an aid in diagnosis, detection, monitoring, determination of predisposition, prognosis, prediction, or determination of physiological status.<\/span>\u00a0<\/span><\/p>\n

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USA SaMD Regulation: FDA Guidance for Device Software Functions and Mobile Medical Applications<\/span><\/b>\u00a0<\/span><\/h3>\n

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The FDA has been a pioneer agency in developing multiple guidance documents for SaMD regulation<\/span>\u00a0<\/span><\/p>\n

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