The compliance of wearable devices

In the context of the Internet of Things, one of the sectors that is spreading rapidly is that of wearable devices.
These are all those electronic devices, often equipped with radio technologies, which can be worn and which generally contribute to the quality of life.

The emerging market for wearable devices includes smartwatches, fitness bracelets, virtual reality glasses, health and wellness devices, but also products not commonly related to these technologies, such as clothing and accessories.

Manufacturers, importers and distributors of such devices may face some difficulties when it comes to ensuring the safety of the products they place on the market.
Companies entering this sector are not always familiar with the regulations regarding electronic devices and in some cases tend to neglect them or apply them incorrectly.
Unfortunately, this can have consequences on the health of end users, but also on legal aspects regarding privacy.

The sanctions for non-compliance of a product are in fact quite high, because for some years they have been able to affect not only the manufacturer, but also all parties in the distribution and sales chain.
It is therefore not unusual for fines to arrive in clusters for a single non-compliant model.

It is therefore necessary to consider the device you intend to market as a whole, identifying potential risk factors and applying all the necessary measures to guarantee the safety of the product.

The new challenges of the market

Wearable devices

The recent diffusion of wearable devices introduces greater complexity in the design phase in order to ensure the quality and safety of products.
The introduction of new technologies into products is a complex process that requires careful planning from its preliminary stages, both because the electronic components and systems used are often not designed for use in wearable devices, and because it is often difficult to determine priori all potential conditions to which the device could be subjected.
Wearable products, which have the health and well-being of the user as their purpose, can fall within the medical field and therefore require specific certification of medical devices.

To draft the EU declaration of conformity The safety and reliability of wearable devices must be evaluated.
The samples must be subjected to a series of tests including:

  • electrical safety testing, to ensure that the user is protected from risks of electric shock or burns related to overheating of electronic parts;
  • radio tests, to check the wireless communication capabilities of devices that integrate WiFi, Bluetooth, etc.;
  • electromagnetic compatibility tests, to ensure that the product does not create disturbances to nearby equipment and that it is not sensitive to disturbances;
  • evidence of human exposure to electromagnetic fields, to evaluate the impact of electromagnetic energy generated by wireless devices on the human body.
    In the specific case of wearable products, this is the SAR measurement (Specific Absorption Rate) which concern the percentage of electromagnetic energy absorbed by the human body when it is near radio frequency devices.

Manufacturers, as primarily responsible for product compliance, are required to implement all the necessary measures to guarantee the safety of the devices marketed, identifying the strategies to be implemented and identifying the technical aspects of the product that could entail a risk factor.

How to obtain the CE mark?

The lab Sicom Testing provides manufacturers, importers and distributors with the necessary support to safely place wearable devices that integrate the latest technologies on the market, offering pre-compliance, testing, CE certification of the products, as well as post-production and batch control.

To request further information on this topic, write to
or call +39 0481 778931.

Related articles

Questions and comments

If you have any questions or comments
Sicom Testing will be happy to answer you.