Approval of wearables
From smart watches with integrated step counters to defibrillator vests, the wearable technologies market is booming. Most of these wearable smart devices are lifestyle or fitness products. However, if a wearable has a diagnostic or therapeutic purpose it requires approval for its target markets just like any other medical device. Here is what manufacturers should know:
When is a wearable a medical device?
Wearables are – as the name implies – wearable electronic devices that contain mobile computer systems with an Internet connection. Examples of wearables approved as medical devices include Zephyr’s BioHarness, a personal monitor module that records physiological parameters such as breathing frequency and skin temperature, and LifeVest from Zoll Medical, a wearable defibrillator. In order to be classified as a medical device a wearable must be designed for human use and have a diagnostic or therapeutic purpose. The European Medical Device Directive 93/42/EEC defines medical devices as “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”
Conformity assessment of wearables
In accordance with the Medical Device Directive, a wearable that is also a medical device must be classified in one of the risk classes I (low risk) to III (high risk). Depending on this classification, the manufacturer must complete a conformity assessment procedure to obtain CE marking for the device. To do this, the manufacturer must appoint a Notified Body to perform conformity assessment (this does not apply to products in the lowest risk class I). In general, the manufacturer must ensure that wearables classified as medical devices comply with the basic requirements of the Medical Device Directive, including evidence of their safety, biocompatibility, skin tolerance, technical specifications and clinical efficacy.
Special testing services for a newly developing market
TÜV SÜD Product Service has designed a portfolio of testing services tailored to the needs of this new growth market. In collaboration with Wearable Technologies Group AG (WT AG), TÜV SÜD now offers global testing services for a range of products in the wearable technologies sector and supports companies through the national and international approval processes they need by supplying product testing for CE marks and proof of conformity under the European Medical Device Directive.