Smart wearable

Wearable device (watch, tracker) collecting personal data and syncing to a companion app.

A wearable processes personal data continuously and syncs over a phone connection. That makes data minimisation and confidentiality of stored data (Annex I Part I g and e) central. The documentation set covers the device firmware and the companion-app integration it depends on.

Where this device type sits in the Regulation

In the Regulation's own structure, 'personal wearables for health tracking and smart textiles' are named in Annex III Class I (Regulation (EU) 2024/2847, Art. 32(2)). Whether THIS specific wearable tracks health and therefore falls in that named category is the manufacturer's guided questionnaire answer, never an assumption of this site.

CRA importance classes for this product type

All other products (default class) Important class I (Annex III) Important class II (Annex III) Critical class (Annex IV)

Typical components

• RTOS firmware
• BLE stack
• Health sensor driver
• Data-sync module
• TLS library

Most relevant Annex I requirements

• I.2(g) — data minimisation for continuously collected personal data
• I.2(e) — encrypt stored and synced health data
• I.2(d) — access control on the pairing and sync channel

Examples

• Smartwatch
• Fitness tracker
• Health monitor band