Are Wearable Devices Considered Medical Devices?

According to the definition of the Federal Service for Surveillance in Healthcare:

Medical devices are any instruments, apparatuses, devices, equipment, materials and other items used for medical purposes individually or in conjunction, or together with other accessories necessary for the operation of the aforementioned items as per indications; this includes also specific software products; medical devices are generally items intended by the manufacturer for the prophylaxis, diagnostics, treatment and medical rehabilitation of medical conditions, diseases and disorders, for monitoring of human body parameters, for medical investigations, recovery, substitution, change of the anatomical structures or physiological functions of the human body, for the prevention or interruption of pregnancy, and their functionality is ensured by means of their pharmacological, immunological, genetic or metabolic effect on the human body. [1]

Wearable devices formally fit this definition. There are even medical codes for such devices. However, according to information on the Roszdravnadzor website, only one product is registered, for example, under code 156970 (wearable recorder of multiple physiological parameters: wristband, watch, finger sensor, head sensor). Moreover, this product can hardly be called wearable. It is rather a physiological monitoring and information management system used in clinics.

But Russian citizens have access to various wearable devices which, according to medical device codes, needed to be registered, such as smart watches, wristbands, heart rate monitors worn on fingers or the head, etc. Thus, Roszdravnadzor does not recognize wearable devices as medical devices, which, in fact, contradicts the definition specified by the Service.

In the opinion of Sergey Vanin, Executive Director of the Medical Device Manufacturers Association, there is no special procedure for registering so-called smart devices. [2]

Nevertheless, in the EU and the USA, devices that require medical intervention for their use fall under the regulation (pacemakers, insulin pumps, various implants, etc.). Such devices undergo technical tests, toxicological studies, clinical trials, etc., as a result of which a Registration Certificate is issued.

Law 152-F3 can be considered one of the means for regulating wearable smart devices (that do not require medical intervention) in the Russian Federation. It regulates the rules for working with personal data that wearable devices can collect. Despite the similarities with the foreign GDPR, there are significant differences between them. We highlight the most important of these [3]:

	152-F3	GDPR
Relevant to the Russian Federation	Yes	Not for all Russian companies
The right to know about the processing of information	Yes	Yes
Right to be forgotten	Yes	Yes
Right to data portability [4]	No	Yes
The need to report data breaches	No	Yes
Cookies and IP addresses are considered data	No	Yes

Wearable devices that are registered or not registered in the Russian Federation as medical devices

In analyzing devices registered by Roszdravnadzor [5], it may be concluded that some codes are most suitable for the definition of wearable devices. For example:

• 156970 — Wearable recorder of multiple physiological parameters.

Description: A wearable powered device (e. g., wristband, watch, finger sensor, head sensor) designed to continuously or periodically measure and record a variety of physiological parameters. The data are usually transferred to a local application (e. g., smartphone) or central database for analysis, which may include assessment of lifestyle factors (e. g., energy expenditure, activity level, sleep phases).

And although this code fits the description of most smart watches and other wearable devices, the Federal Service does not register them as medical devices. Only one device is registered by this code despite the fact it does not match the code name and is not wearable (according to the definition we gave in previous articles).

That is, some wearable devices,

• by definition, are medical devices and codes are provided for them, but they are not registered;
• and for some devices there are simply no medical codes.

Below are some codes that are most suitable for the foreign definition of wearable devices.

Codes	Devices	Number of registered devices
108170, 341680	Devices for continuous monitoring of body temperature	4
156970	Wearable recorder of multiple physiological parameters (e. g., wristband, watch, finger sensor, head sensor). The data are usually transferred to a local application (such as a smart phone) or a central database for analysis	1
241660	Ambulatory fall detector (in the form of a patch, pendant, wristband)	0
241700	Home alarm system (e. g., wearable pendant, wall button, fall detector)	1 (does not match the code name and is not wearable)
264170	Recorders for monitoring the pH of gastric acid	3
333010	Insole for pressure monitoring	0
139000	Wearable speech training device	1
150310	Voice synthesis/transformation device	0
227560, 227980	Orbital system implant for retinal epiretinal prosthesis with a video camera	0
227980	System for retinal epiretinal prosthesis with a video camera	0
212350	Insulin deficiency alarm device	0
381110	Adaptive speech generator device	0
125100	Implantable heart monitor	3
157540	Patient monitoring system module for ischemia control	0
207650	Insulin infusion pump/glucometer	4
372930	Transcutaneous electrical stimulation wristband for tremor suppression	0
113850, 130870, 113850, 127970, 173110, 178730, 343500, 113850, 130870, 187970, 204370, 228560, 247910, 272030, 290340, 323690, 373560	Hearing aids of various types	Widespread practice of registration
139000	Adaptive device for speech training	1
150310, 381110	Voice synthesis/transformation device	0
276590	Adaptive electronic device for oral reproduction of text	0
139050, 210170, 210180, 334620, 334630, 334640, 334650, 335150,	Implantable pacemakers of various types	Widespread practice of registration
266500, 266430, 266500, 356940	External pacemakers of various types	Widespread practice of registration
167950, 167920	Artificial heart	2
167920	Circulatory assist device	1
210150	Cardioverter-defibrillators of various types	Widespread practice of registration
235440	Artificial kidney	4

Summarizing all of the above, it can be concluded that:

• The registration of medical devices does not correspond to the market offer. The Russian Federation does not control the sale and manufacture of wearable devices which do not require medical intervention (such as smart accessories, clothing and patches).
• Wearable devices which require medical intervention (insulin pumps, pacemakers) are registered as medical devices.
• At the same time, all wearable devices are subject to control by Law 152-F3 “On Personal Data”.

References

1. Federal’naya sluzhba po nadzoru v sfere zdravoohraneniya [Electronic resource]. URL: https://roszdravnadzor.gov.ru/medproducts

2. Otpisat’sya M.K.P. Ponyat’ i uprostit’ [Electronic resource]. 2020. URL: https://www.kommersant.ru/doc/4259729

3. Krasil’nikov M. GDPR vs FZ-152 [Electronic resource] // vc.ru. 2018. URL: https://vc.ru/flood/42581-gdpr-vs-fz-152

4. Kozlyuk A. GDPR — novye pravila obrabotki personal’nyh dannyh v Evrope dlya mezhdunarodnogo IT-rynka [Electronic resource] // Хабр. Habr, 2017. URL: https://habr.com/ru/company/digitalrightscenter/blog/344064/#post-content-body

5. Federal’naya sluzhba po nadzoru v sfere zdravoohraneniya [Electronic resource]. URL: https://roszdravnadzor.gov.ru/

Text: Anthony Belokopytov

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e-mail: anton.belokopytov@beawire.com