Software as a Medical Device (SaMD) - IMDRF Definition and Categorisation

Following the growing importance of technology in healthcare, Medical Devices have begun to play an increasingly important role in the further development of the life sciences landscape.

One of its more remarkable and fastest growing segments goes under the name Software as a Medical Device. This blog shares insight into the definition and categorisation, as used by the International Medical Device Regulators Forum.


International Medical Device Regulators Forum (IMDRF)

  • International forum founded in 2011 to discuss the future of medical device regulatory harmonisation.

  • Current members include Europe, USA, Australia, Brazil, Canada, China, Japan, Russia, Singapore and South Korea.

  • Not an authority providing regulations but nevertheless a notable player in the international medical device landscape

Software as a Medical Device (SaMD)

Following the growing importance of technology in healthcare, Medical Devices have begun to play an increasingly important role in the further development of the life sciences landscape. One of its more remarkable and fastest growing segments goes under the name Software as a Medical Device. The IMDRF defines Software as a Medical Device (SaMD) as follows:


“Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

Definition

Important to note when it comes to SaMD:

  • It can be used interfaced or in combination with products such as other SaMDs, general-purpose software and other medical devices

  • This definition includes both mobile apps and In-Vitro Diagnostic (IVD) Medical Devices

  • It can run on general computing platforms such as smartphones, computers, laptops…

Software cannot be considered SaMD when it is necessary for a hardware medical device to achieve its intended medical purpose or when the purpose of the software is to drive a hardware medical device.

Some examples of SaMD:

  • Software that performs image processing to detect diseases

  • Software that works as a treatment planning tool, supplying information

  • BMI, body fat and heart rate calculators

  • Software regulating installed medical devices (e.g. pacemaker) Examples

The SaMD landscape is mixture of both experienced medical device companies and newcomers unfamiliar with medical device regulations and terminologies that are developing a broad spectrum of applications. Unique in the way that it is part of a highly-connected, interactive and socio-technical environment, where frequent changes and modifications are implemented more quickly and efficiently.


Categorisation IMDRF Categorisation of SaMD



Category IV Criteria

  • Provides information to treat or diagnose a disease/conditions in a critical situation or condition and is considered to be of very high impact.

Examples

  • SaMD that is used to perform diagnostic analysis for making treatment decisions in patients with acute stroke.

  • SaMD that calculates the fractal dimension of a lesion and the surrounding skin to provide diagnosis or identify if the lesion is malignant or benign.


Category III Criteria

  • Provides information to treat/diagnose a disease/conditions in a serious situation or condition and is considered to be of high impact.

  • Provides information to drive clinical management of a disease or conditions in a critical situation or condition and is considered to be of high impact.

Examples

  • SaMD that uses the microphone of a smart device to detect interrupted breathing during sleep and sounds a tone to rouse the sleeper.

  • SaMD intended to serve as a radiation treatment planning system as an aid in treatment by using patient information and provides specific parameters tailored for a particular tumour and patient.

Category II Criteria

  • Provides information to treat/diagnose a disease or conditions in a non-serious situation or condition and is considered to be of medium impact.

  • Provides information to drive clinical management of a disease or conditions in a serious situation or condition and is considered to be of medium impact.

  • Provides information to inform clinical management for a disease or conditions in a critical situation or condition and is considered to be of medium impact.

Examples

  • SaMD that analyzes heart rate intended for a clinician as an aid in diagnosis of arrhythmia.

  • SaMD that uses data from individuals for predicting risk score for developing stroke or heart disease for creating prevention or interventional strategies

Category I Criteria

  • Provides information to drive clinical management of a disease or conditions in a non-serious situation or condition and is considered to be of low impact.

  • Provides information to inform clinical management for a disease or conditions in a serious situation or condition and is considered to be of low impact.

  • Provides information to inform clinical management for a disease or conditions in a non- serious situation or condition and is considered to be of low impact.

Examples

  • SaMD that sends ECG rate, walking speed, heart rate, elapsed distance, and location for an exercise-based cardiac rehabilitation to a server for monitoring by a qualified professional.

  • SaMD that collects data from peak-flow meter and symptom diaries to provide information to anticipate an occurrence of an asthma episode.


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