To ensure the sustainable development of innovative technologies, the International Medical Device Regulatory Forum (IMDRF) has developed a special framework for software with the intended medical purpose. Three guidance documents dedicated to terminology, risk-based classification, and quality management system have been published. They have been developed by the IMDRF SaMD Working Group, a special division formed to address issues related to medical software.

Software as a Medical Device (SaMD): Key Points

The first document issued by the IMDRF provides the medical device manufacturers and other parties operating with medical software with the definitions of the most important terms related to the software. 

According to the document, the software used in the healthcare sphere could be divided into:

  • the software with an intended medical purpose (those used to make clinical decisions), and
  • the software without an intended medical purpose (various tools used for administrative or financial purposes).

This division is the most important one since all the requirements applied for the software actually depend on the category from above the particular software in question belongs to. 

Existing regulation mostly covers the issues associated with software incorporated in medical devices. At the same time, the provisions regulating such software not always applicable in the case of Software as a Medical Device (SaMD). Hence, according to the IMDRF guidance, all software with an intended medical purpose could be divided into:

  • the software is a medical device (other terms used for this type of software are «embedded» or «part of»), and
  • the software as a medical device (SaMD).  

The present guidance document is focused on the key terms and definitions associated with the latter. In particular, the document provides the terms and definitions to be used in future guidance documents and regulations to ensure consistency in the terminology used. Some of the national regulating authorities have already commenced the development of their own approaches to the SaMD, so it is important to use common terminology to improve International cooperation in the future. 

Some of the terms included in the guidance have been previously defined in the appropriate document issued by the Global Harmonization Task Force (GHTF). 

The present IMDRF guidance covers all SaMD irrespectively of the platform and/or software technology used. At the same time, the software that is an accessory to a medical device actually falls outside the scope of the guidance (except the cases when such software meets the definitions of software as a medical device outlined therein).

SaMD and the Main Definitions Associated Thereto

According to the document, the term «Software as a Medical Device» (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. 

The guidance also outlines the main points SaMD meets, namely:

  • SaMD could also be an in vitro diagnostic medical device,
  • SaMD could operate on usual (non-medical) computing platforms,
  • In order to achieve its intended purpose, it should not be part of a hardware medical device,
  • SaMD could be connected with other medical devices or software,
  • SaMD could also exist in a form of a mobile application. 

The definition of the term «Medical Purpose» is provided through the definitions of the medical device and in-vitro diagnostics medical device. Besides the points usually applied to the medical device, SaMD could also:

  • Provide means and suggestions for mitigation of disease,
  • Provide information for determining compatibility, detecting, diagnosing, monitoring, or treating physiological conditions, states of health, illnesses or congenital deformities,
  • Be an aid to diagnosis, screening, monitoring, determination of predisposition, prognosis, prediction, determination of physiological status.

Another import concept related to SaMD describes the changes made to the software. In particular, the guidance distinguishes several types of maintenance, including adaptive, perfective, corrective, and preventive. According to the document, such modifications should be treated as changes to the medical device, hence the regulating authority should be informed accordingly. 

The definition of the medical device manufacturer to be applied in the case of SaMD is the same as for other medical devices. It outlines the same responsibilities related to the device placed on the market, including the obligations related to the appointment of the authorized representative and post-market surveillance. 

The guidance also provides the definition of the intended purpose of a medical device as the objective intent of the manufacturer regarding the use of a product, process, or service as reflected in the specifications, instructions, and information provided by the manufacturer. 

At the same time, in the case of software as a medical device, the IMDRF states that marketing and promotional materials used by the manufacturer should be also treated as the information provided by the manufacturer. Thus, any and all details and statements made by the manufacturer and contained therein should be correct and accurate to avoid confusion. In any case, the information contained in such materials should not mislead the customers about the actual intended purpose of the SaMD, its features, functions, and the way it should be used.

Regulatory Background 

The present IMDRF guidance, as well as other guidance documents dedicated to SaMD-related issues, is addressed to the national regulating authorities and should be considered when developing the regulations in the sphere of medical software. In particular, the terms and definitions provided therein should be used in any regulations to be issued in the future. 

It is also important to mention that the term SaMD actually replaces the term «standalone software» or “standalone medical device software” used previously, while the ideas and concepts covered by the aforementioned terms are being covered by the concept of SaMD. 

In some part, the present IMDRF guidance also refers to the terms and definitions provided in the international standard ISO/IEC 14764:2006 Software Engineering – Software Life Cycle Processes – Maintenance. 

When outlining the scope of the medical devices covered by the guidance, it is important to mention that certain medicinal products could be defined as medical devices in one country but fall outside this definition in others. Such products include, inter alia, the following ones:

  • Disinfection substances,
  • Aids for persons with disabilities,
  • Devices incorporating animal and/or human tissues,
  • Devices for in-vitro fertilization or assisted reproduction technologies. 

Summarizing the information provided here above, the present IMDRF guidance on the SaMD key definition provides the regulating authorities and other industry representatives with the definitions of the most important terms used in the sphere of medical devices. The document also describes the approach to be used to distinguish the software as a medical device from other software with the intended medical purpose.

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