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Defining and Regulating the Complex World of Software as a Medical Device

The medical devices landscape has changed dramatically in recent years with the shift from hardware-based medical devices to the advent of smart, standalone software technology medical devices. However, the definition of what constitutes software as a medical device (SaMD) is not that simple, and that poses some unique challenges when it comes to regulations. Yervant Chijian at PharmaLex states that since regulations were written well before the emergence of SaMDs, health authorities have had to consider how to adapt these regulations to the fast-moving nature of the technologies.


Defining and Regulating the Complex World of Software as a Medical Device

The use of software in medical devices has grown exponentially and in different ways. However, SaMDs are a distinct class, separate from what is referred to as software in a medical device (hardware incorporating software as an integral part of its function) and software used to help manufacture or maintain a medical device. The introduction of the SaMD class brings with it a new group of innovators and manufacturers, many of whom have no or very little experience with regulations and are struggling to get up to speed with the different global regulatory requirements and what they mean for their products.

The Regulatory Landscape

Let’s explore the key regulatory challenges that are triggered by these evolving technologies and the steps regulators and standards bodies are taking to address these challenges.

A product is defined as an SaMD if the software is standalone and meets the definition of a medical device, which is that it is intended to be used for diagnosis, screening, prevention, monitoring, treatment or alleviation of disease.

While the nature of SaMDs is complex and there are inevitably different interpretations in different jurisdictions, as a result of this, there are efforts to harmonise regulatory approaches. The International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators, formed the Software as a Medical Device Working Group aimed at encouraging innovation and access to SaMDs by establishing key definitions, a risk categorisation framework, quality management system principles, and a clinical evaluation pathway.

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