November 29, 2023

A Guide to Software as a Medical Device

Software as a Medical Device (SaMD) plays a crucial role in diagnostics, treatment, and overall healthcare management. In this guide to SaMD, we’ll explain everything you need to know about SaMD, including its definition, examples of SaMD, the regulatory landscape, development challenges, benefits, and future trends.

A Guide to Software as a Medical Device

Software as a Medical Device (SaMD) is a growing category in healthcare as the move towards technology-enabled health continues. SaMD plays a crucial role in diagnostics, treatment, and overall healthcare management. In this guide to software as a medical device, we’ll explain everything you need to know about SaMD, including its definition, the difference between SaMD and DTx, examples, the regulatory landscape, development challenges, benefits, and future trends.

What is Software as a Medical Device?

Software as a Medical Device (SaMD) refers to software intended to be used for medical purposes, with its own inherent medical functionality. Unlike general health/wellness software, SaMD impacts patient outcomes. It encompasses a wide array of applications, ranging from diagnostic tools and treatment planning software to health monitoring apps.

The term Software as a Medical Device is officially defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

Are Digital Therapeutics Software as a Medical Device?

A digital therapeutic (DTx) is a type of SaMD, in that it is also software used for medical purposes. While SaMD is a generic term for software intended to be used for one or more medical purposes, the term DTx is limited to software that intervenes with treatment based on clinical evidence for the treatment, management, or prevention of diseases or disorders. Consequently regulatory authorities treat DTx as SaMD.

Examples of Software as a Medical Device

Some examples of SaMD include smartphone applications that are designed to treat anxiety, X-ray image-processing software, and software that includes an algorithm to make a clinical diagnosis. Software that monitors lifestyle interventions such as daily activities or meal planning may or may not be considered SaMD, depending on whether the intended purpose is medical. Exercise bikes can be considered medical devices if their intended purpose is medical. For example an exercise bike used to diagnose cardiovascular disease would be regulated as SaMD.

Regulatory Landscape for SaMD

Navigating the global regulatory landscape for developers of SaMD can be complicated, with different regional standards and regulations often applicable. Various regional bodies, such as the U.S. Food and Drug Administration (FDA), the National Competent Authorities in Europe, the European Medicines Agency (when there is a cross-over relationship with a medicinal product) and the Therapeutic Goods Administration set guidelines and regulate SaMD to ensure the safety and effectiveness of medical software in their regions. 

The International Medical Device Regulators Forum (IMDRF)

The International Medical Device Regulators Forum (IMDRF) which was formerly known as the GHTF Global Harmonization Task Force consists of regulators (competent authorities, notified bodies) from around the world with the aim to harmonize guidelines. Since 2013, the Software as a Medical Device Working Group, chaired by the FDA, has been the key group developing this guidance to support innovation and timely access to safe and effective SaMD. The working group has also been responsible for the key definitions for Software as a Medical Device, the framework for risk categorization for SaMD, the Quality Management System for SaMD, and the process for clinical evaluation of SaMD.

In terms of risk categorization, there are four risk categories, which are defined by two factors which both are divided into three levels. The IMDRF categories are defined by the following two factors (with three levels each). These are determined by:

• Significance of information provided by SaMD to healthcare decisions ("significance on the action taken by the user based on the information"). The three levels are: Treat or diagnose, Drive clinical management or Inform clinical management

• “State of Healthcare situation or condition” that the SaMD is intended for. The three levels are: Critical situation or condition, Serious situation or condition or Non-serious situation or condition,

The risk category I-IV, is determined by the combination of these two factors (in a matrix). 

The EU MDR MDCG guidelines 2019-11 maps the IMDRF categories to MDR medical device classes.

FDA Guidelines for SaMD

In the United States, the FDA provides comprehensive guidelines for SaMD classification and regulatory compliance. The classification process takes into account the potential risks associated with the software, determining the level of scrutiny and requirements for development and marketing. The categories are in relative significance to each other. Category IV has the highest level of impact, Category I the lowest. The FDA has also released new guidance on prescription drug use-related software (PDURS), which outlines the implications on drug labeling when software accompanies a prescription drug.

EU Medical Device Regulation (MDR) for SaMD

In Europe, the Medical Device Regulation (MDR) governs the development and deployment of SaMD. The MDR classifies medical devices, including SaMD, into four different risk classes based on the potential harm they may pose to patients and users. The medical device class determines the level of scrutiny and regulatory requirements that apply to the development, manufacturing, and marketing of the SaMD. 

The class is based on classification rules, which are defined by the following two factors relevant to the SaMD:


• Intended Use: The intended purpose and use of the SaMD with devices intended for critical diagnostic or therapeutic purposes are generally subject to higher scrutiny.

• Inherent risk of the device: The potential impact on patient safety, including the severity and reversibility of harm.

The MDR classifies medical devices into four main risk classes, taking into account the intended purpose of the device and inherent risks: 

• Class I: Low Risk. Devices in this class present low risk to patients and users. They are subject to self-certification.

• Class IIa: Low to Medium Risk. Devices in this class pose a slightly higher risk than Class I devices. They undergo a more rigorous conformity assessment process.

• Class IIb: Medium to High Risk. Devices in this class pose a higher risk, and their conformity assessment involves a more thorough evaluation.

• Class III: High Risk. Devices in this class pose the highest risk to patients. They undergo the most comprehensive conformity assessment, including a thorough evaluation of clinical data.

Rule 11, often referred to as the Software rule, is the classification rule most likely to be used to determine the medical device class of the SaMD. According to Rule 11, the types of software medical devices not classified as Class I medical devices are those which:

• Provide information used for diagnostic or therapeutic purposes (which makes them Class IIa or higher),

• Monitor physiological processes (which also affect at least Class IIa).

All classes except class I are assessed for conformity, which is the process by which a manufacturer demonstrates that their SaMD complies with the General Safety and Performance Requirements (GSPR) of the MDR. Higher-risk classes generally require more extensive clinical evidence to demonstrate safety and performance.

It's important for manufacturers of SaMD to carefully define the intended use and characteristics of their devices to determine the applicable classification rule (or sub-rule) to determine the classification, as the regulatory pathway is either conformity assessment by Notified Body (Class IIa and higher) or self-certification (class I).

Challenges in Developing SaMD

Developing SaMD comes with its own set of challenges. Ensuring data privacy, achieving interoperability with existing healthcare systems, and addressing cybersecurity concerns are all critical. That’s why many life sciences companies are choosing to partner with technology companies with pre-built SaMD platforms, which can be easily configured, and have data privacy and security built-in from the start.

Benefits of SaMD

Despite the challenges, SaMD solutions contribute to improved efficiency in healthcare delivery, enhanced diagnostic accuracy, alternative treatment options, and better health outcomes. SaMD is also changing the way in which patients can engage with their own health and care, and can provide novel ways to collect and utilize health data. SaMD has the potential to improve patient care by providing patients with better tools, and healthcare professionals with data that can improve clinical decision-making.

Future Trends in SaMD

Emerging technologies such as artificial intelligence (AI) and machine learning (ML) are poised to shape the future of SaMD. The integration of these technologies holds promise for more accurate diagnostics, personalized treatment plans, and even greater efficiency in healthcare. The FDA has recently released a discussion paper and request for feedback on the proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based SaMD, which will help guide manufacturers exploring the use of AI/ML in the future. 

As we continue to move towards a world of digital everything, SaMD with diagnostic and interventional applications will play an increasingly important role in the healthcare system. Harnessing the benefits of SaMD will contribute to providing important improvements in individual health outcomes in the future.

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