Software Application Qualify as Medical Device: A Regulatory Guide

We will explore when software application qualifies as medical device and how they are regulated. As a source for this information, we used guidance: Medical devices software applications (apps) from Medicines and Healthcare Products Regulatory Agency in the UK. 

Artificial intelligence used as a support tool in medicine offers new methods of diagnosis, treatment, and patient care. The innovation, although significant, is still being improved and requires improvement. However, a transparent regulatory framework is needed at this point. 

Medical software can be applied to a wide range of products. It will be both specialized software used to decompile images on a descriptive station cooperating with a CT scanner and, under certain conditions, a phone application from the health/fitness department. 

Let’s start with the definition: “Medical devices are defined as devices that are intended for use for medical purposes. The medical use is attributed to the product by the manufacturer. The manufacturer shall determine, through the label, instructions for use and promotional materials related to a given product, its specific medical use.” 

That we know the definition, we can examine this topic more closely. 

Software is most likely a device if it’s: 

• associated with a specific drug/device (possibly an accessory). 
• designed to influence the actual treatment — dose, implant size, treatment time, etc. 
• results in diagnosis or prognosis — ensures the risk of disease in the future 

Software is unlikely to be a device if: 

• Reproduces a paper document in digital format. In this case, the healthcare professional makes decisions based on the advice displayed. 
• Follows the path of treatment/treatment – no decisions – only provides information. 
• Contains decision points, and options can be explained. However, it is the healthcare professional who decides. 
• Only offers lifestyle treatment options or referral advice (e.g. a visit to your doctor or monitors wellbeing). 

Disease prevention includes software that claims to be able to prevent specific diseases. It does not include products that claim to prevent injury or disability. To qualify as a medical device, there must be a link to a specific disease or disease. 

Examples that might be devices include: 

• Apps and software that claim that the output from a physical device can prevent disease. 

Examples that are likely not devices include: 

• Apps and software that only provide guidance or advice on prevention. 

As we can see in the examples above, health-related software may or may not always be a medical device. The purpose of this software and its impact on the diagnosis, treatment, or prevention of diseases are crucial. 

It can be concluded that if software only digitizes documents, presents information, or offers general advice, it is not a medical device. 

To sum up, software applications are considered to be a medical device that affects the course of the patient’s treatment, or is used to diagnose them, they will be treated as a medical device. And thus it is subject to appropriate legal regulations. 

Source:

Guidance: Medical device stand-alone software including apps (including IVDMDs): https://www.gov.uk/government/publications/medical-devices-software-applications-apps