CRA compliance for Smart wearable
All other products (default class)
About CRA compliance for Smart wearable
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.
What the All other products (default class) means for this product
The Cyber Resilience Act applies to a wide range of products with digital elements. Products that are not on the Annex III (important) or Annex IV (critical) lists fall under the default class. Conformity is typically assessed under Module A, the manufacturer's internal control, without a notified body. The full set of Annex VII technical documentation, an EU Declaration of Conformity and the Annex I requirements still apply.
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.
Conformity assessment
Module A (internal control, self-assessment)
Annex III / IV structure
Not listed in Annex III or Annex IV (Regulation (EU) 2024/2847, Art. 32(1)(a))
Products in this class are those NOT named in Annex III or Annex IV:
- No categories from Annex III or Annex IV are named for this class.
This is the Regulation's own structure (Regulation (EU) 2024/2847, Art. 32(1)(a)): everything that is not named in Annex III or Annex IV sits here. Whether a particular product is actually excluded from those annexes is the manufacturer's guided questionnaire answer, never an assumption of this site.
Key obligations
- Annex VII technical documentation for the product and its vulnerability handling
- EU Declaration of Conformity (Annex V) under the sole responsibility of the manufacturer
- Annex I essential requirements: secure by default, update mechanism, access control, data protection, incident resilience
- Annex I Part II vulnerability handling: SBOM, CVD policy, security contact, coordinated vulnerability disclosure
- Support period determination per Article 13(8) and support-period information
- Reporting actively exploited vulnerabilities and severe incidents per Article 14
Typical components to document (SBOM)
RTOS firmwareBLE stackHealth sensor driverData-sync moduleTLS library
Relevant Annex I requirements
I.2(g)— data minimisation for continuously collected personal dataI.2(e)— encrypt stored and synced health dataI.2(d)— access control on the pairing and sync channel
Get the compliance document set
Annex VII technical documentation, EU DoC and the Annex I checklist, generated from your product's SBOM. Leave an email and we will send it when the generator is open.