Wearables under the CRA

When a wearable is important

Products worn on the body that have a health-monitoring purpose and are not covered by the medical device regulations, and products intended for children, are important products of class I. For them, internal control is only sufficient with full application of harmonised standards.

Boundary with medical devices

If a device falls under the regulations on medical devices or in vitro diagnostics, the CRA does not apply; those regulations have their own cybersecurity requirements. The boundary depends on the intended purpose.

What counts in practice

Health data need special protection: secure pairing with the phone, encrypted transmission, protection of stored data and a clear statement of how long updates are provided. Devices with Bluetooth or Wi-Fi are also subject to the Radio Equipment Directive.