by Diana Ribeiro, MPharm – Freelance Medical Writing Consultant
In recent years, there have been some changes in the medical device landscape that have repercussions in the way they are used, regulated, and marketed. In Europe, the introduction of the European Union Medical Devices Regulation (EU MDR) brought challenges for manufacturers and other stakeholders regarding device classification and market access of devices, namely those that have been in the market for a long time (legacy devices). In addition, the number and capability of consumer-grade devices continues to expand. These consumer-grade devices include wearables, smartwatches, and apps. Some of these devices may have medical applications, and are therefore considered medical devices, subject to MDR rules.
Considering these changes, how can we distinguish between a consumer-grade and a medical device? Or even if our device classifies as a medical device? In this article, we will explore the differences between consumer-grade and medical devices, when should a device be considered a medical device, and where the lines between them blur.
Traditional Medical Devices and Their Classification
In the EU, and according to the MDR, medical devices are classified according to the risk they pose to patients, with lower-risk devices such as wheelchairs and reading glasses being placed in Class I and higher-risk devices like pacemakers and heart valves allocated to Class III. In the United States, the Food and Drug Administration (FDA) also uses a risk-based approach to the classification of medical devices, albeit with some differences in device placement.
The risk categories attributed by the EU and the FDA, along with some examples are provided in Table 1. According to this classification, consumer-grade medical devices would be those in classes I and II for the FDA, and those in class I (both sterile and non-sterile) according to the EU MDR.
Table 1. Classification of medical devices
The MDR and FDA classification systems can be applied in a more or less straightforward way for many devices. However, the arrival of wearables, the debut of software as a medical device, and the confluence of lifestyle and health monitoring with the collection of health data that can be used for medical purposes will continue to be a challenge for both manufacturers and regulators.
The Rise of Consumer-grade Medical Devices
For the past decade or so, the use of devices such as smartwatches, smart jewellery and other devices incorporating sensors has been steadily growing. While the major driving force for the ubiquity of these devices is the growth of the consumer sports, fitness, and wellness markets, the technological advancements that allowed their miniaturisation and integration can put them on par with more traditional medical devices.
The rise in the use of monitoring wearable devices has been accompanied by other trends. The first is the desire of patients to monitor and maintain their health by themselves, leading them to actively seek the tools to do so. The other is that healthcare is shifting from the traditional hospital environment (where patients are either admitted as inpatients or must regularly visit the hospital for appointments) to a home-centric model, which can empower and be more comfortable for patients but also has the potential advantage of reducing costs.
According to a study published in 2019 (Holtz, 2019), healthcare providers are receptive to the use of consumer-grade devices and apps for tracking health data in their patients. In this survey study, providers reported that the use of these behavioural tracking technologies was helpful in clinical encounters and trusted the data coming out of their patients’ wearables and apps. These findings were echoed in another survey study (Zaslavsky, 2022), where the authors found that a high proportion of primary care providers endorse live video for common mental health conditions and mobile apps for health-promoting behaviours.
Convergence Between Consumer Wearables and Medical Devices
The world of consumer wearables and medical devices are slowly but steadily coming together. Medical wearables are the next logical step for medical device manufacturers who want to reach a wider market and for players in the consumer sector who want a piece of the high-value medical market. Many leader companies in the consumer wearables sector are now moving toward producing personal health devices, while traditional medical device manufacturers are now developing devices (wearable or not) intended to be used outside the clinic or hospital but continuing to feed medical-grade data into the patient treatment workflow.
But when is wearable technology considered a medical device? This is an important question, because for all their investment in accuracy, consumer wearables’ companies clearly state that their smartwatches and other devices are not medical devices. This mainly relates to the intent behind data capture and its use.
Keeping with the example of smartwatches, the intent of capturing the daily number of steps, heart rate, and activity levels is to inform their user about these factors. For it to be considered a medical device, the data would be collected with the intent of diagnosing or treat a medical condition. We can already see some lines blurring, when data coming from consumer-grade devices are used by healthcare practitioners to monitor the overall health of their patients or adherence to physical exercise, for example. However, companies can defend themselves saying that this is an off-label use, and not the intended use of their device. EU guidance supports this, saying that certain types of software, even when used with a medical purpose, will not be classified as a medical device, if it provides only neutral assistance in medical decision-making, if it is intended to provide education, to monitor fitness, health, or wellbeing, or if it only performs administrative functions, such as booking appointments and requesting prescriptions (MEDDEV 2.1/6).
As we can see, the main factor to consider to consider a device as a medical or a consumer-grade one is if there is a medical intent behind it. However, with the multiplicity of opportunities for new technologies comes also a further blurring of the line between each category. For example, an app that collect data on patients’ moles can be said to only provide neutral assistance in medical decision-making process and therefore be a consumer-grade device, but one incorporating machine learning processes to classify the risk of developing skin cancer would fall into the medical device category. Further blurring lines can be seen in the use of data coming from continuous glucose monitors and used in a mobile app to track trends or even to advise the patient regarding medication or need for medical care.
The use of both consumer-grade wearables and wearable medical devices is changing the digital health landscape, and are at the forefront of mobile health. In a previous article, we discussed the role of wearable devices in the advancement of decentralised clinical trials, highlighting how they can enable remote collection of patient data, promote patient engagement and compliance, and even facilitate the recruiting process.
There are challenges to overcome with the use of new technologies and medical wearables, namely those related to data privacy and cybersecurity. Despite these challenges, the use of wearable medical devices will continue to expand, providing opportunities for medical devices companies and improving patients’ lives.
MDCG 2021-24 – Guidance on classification of medical devices
FDA. Classify your medical device. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
ECRI. The growing use of consumer-grade medical devices: Advice for physicians and their patients. (n.d.). Retrieved January 2, 2023, from https://www.ecri.org/components/HDJournal/Pages/Advice-on-consumer-grade-medical-devices.aspx
Holtz, B., Vasold, K., Cotten, S., Mackert, M., & Zhang, M. (2019). Health Care Provider Perceptions of Consumer-Grade Devices and Apps for Tracking Health: A Pilot Study. JMIR mHealth and uHealth, 7(1), e9929. https://doi.org/10.2196/mhealth.9929
Zaslavsky, O., Chu, F., & Renn, B. N. (2022). Patient Digital Health Technologies to Support Primary Care Across Clinical Contexts: Survey of Primary Care Providers, Behavioral Health Consultants, and Nurses. JMIR formative research, 6(2), e32664. https://doi.org/10.2196/32664
Consumer wearables & medical devices convergence | voler systems. Retrieved January 2, 2023, from https://www.volersystems.com/blog/news/the-convergence-of-consumer-wearables-and-medical-devices
MEDDEV 2.1/6 – Guidance document Medical Devices – Scope, field of application, definition – Qualification and Classification of stand alone software. http://www.meddev.info/_documents/2_1_6_ol_en.pdf
Mishcon de Reya LLP. When is wearable technology considered a medical device? Retrieved January 2, 2023, from https://www.mishcon.com/news/when-is-wearable-technology-considered-a-medical-device
Suver, C., & Kuwana, E. (2021). Mhealth wearables and smartphone health tracking apps: A changing privacy landscape. Information Services & Use, 41(1–2), 71–79. https://doi.org/10.3233/ISU-210114