Electronic Products & Technology

Ensuring compliance in the smart wearables market

By SGS   

Electronics Regulations & Standards design electronic regulations

Wearable products that fail to conform to the industry standards are at risk of recall

Since 1500 CE and the invention of the wearable clock, people have loved wearable technology. Today, we are fascinated by smart wearable devices (SWD) that enhance our daily lives in a multitude of ways.

A growing market

It was predicted in 2014 that the global market for SWD would be worth $22.9-billion by 2020 (all figures in USD$). In reality, this figure was exceeded far earlier, with the market reaching more than $25-billion and over 245 million devices sold by 2019. This growth is expected to continue, with an estimated 368.9 million users of smart wearable tech by 2024, each spending at least $79.75.

What are smart wearable devices?

The term wearable device, sometimes called wearable technology, refers to items that are worn on the body that contain electrical or electronic components. Examples include watches, lights on shoes, and gloves that heat the hands. However, SWD takes wearable technology to the next level, with these wearable devices now able to communicate wirelessly with other devices.

Source: SGS

SWDs have proven to be very popular in the fields of entertainment, information and communication, medicine, health and fitness. The health and fitness sector has been a key driver in the market, with fitness trackers still the largest product category by unit sales.


SWD are now readily incorporated into various aspects of our daily lives and the range of products available to consumers is ever growing. Examples include:

* Watches that connect to smart phones to show messages etc.

* Wireless headsets to relay telephone calls

* Exercise trackers

* Sleep trackers

* Clothing & boots that warm your feet

Wearable technology has certainly come a long way since Peter Henlein designed the first wearable clock. There are now even canine trackers that connect with a smart phone, showing that SWDs are not just for humans.


SWDs incorporate both an electrical and non-electrical component and are, by their very nature, classified as cross category products. The electrical component might be contained in jewelry, clothing, footwear, etc. and it therefore needs to conform to the regulatory requirements for both electrical and electronic (EE) products and the relevant regulations for the surrounding structure.

Products that fail to conform to these standards are at risk of recall. In some cases, the reason for the recall has been the electronic component – for example, in 2008 the EU recalled some wireless headsets where the lithium-ion batteries short circuited, causing overheating. In other cases, the cause of the recall was the non-electrical component – for example, in the US in 2014, tracking wristbands were recalled because they irritated the skin and caused blistering.

It is therefore important for manufacturers to ensure their products conform to all the relevant legislation enforced in their target market. This can make the process more complex as product testing needs to be considered in relation to:

  • Mandatory compliance:
  • Product safety
  • Electromagnetic compatibility (EMC)
  • Radio Frequency
  • Chemical compliance
  • Compliance related to other categories (textiles, toys, etc.)
  • International Type Approval – CE or FCC
  • Patent & alliance logos – Bluetooth, Wi-Fi Certified, etc.
  • Performance & reliability testing – specific to type of product (e.g., performance tests for shoes)

Manufacturers operating in EU markets need to ensure mandatory chemical substance compliance against a variety of pieces of legislation, including REACH, directives on packaging and batteries, and regulations covering persistent organic pollutants (POPs) and the allergenic effect.

In terms of EE components, EU regulations include:

  • Directive 2011/65/EU Restriction of Hazardous Substances (RoHS)
  • Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE)
  • Regulations on radio frequency and electromagnetic compatibility (EMC)

When operating in the US, manufacturers must consider:

  • Toxics in Packaging Clearing House (TPCH)
  • California Proposition 65
  • US Public Law 104-142 for batteries
  • Regulations enforced by the Federal Communications Commission (FCC)

Most countries will also have safety standards to which the product must conform. These regulations represent just the tip of the iceberg and manufacturers are advised to partner with an experienced testing and certification service provider to ensure they are complying with the correct legislation.





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