CRA compliance for Smart wearable
Critical class (Annex IV)
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 Critical class (Annex IV) means for this product
Critical products are listed in Annex IV and are subject to the strictest conformity assessment routes under Article 47 and Annex VIII, always with third-party involvement. The technical documentation and its traceability are central because the notified body's examination and subsequent surveillance rest on them.
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
EU-type examination + conformity based on full quality assurance (Module H), notified body required
Annex III / IV structure
Annex IV (critical) (Regulation (EU) 2024/2847, Art. 47)
The Regulation's own structure names these 3 items in Annex IV:
- hardware devices with security boxes
- smart meter gateways and other advanced security purpose devices for secure cryptographic processing
- smartcards and similar devices, including secure elements
This is the Regulation's own structure (Regulation (EU) 2024/2847, Annex IV), not an assessment of any specific product. Whether a particular product falls within a named item is the manufacturer's guided questionnaire answer, never an assumption of this site.
Key obligations
- Strictest conformity assessment route under Article 47 and Annex VIII
- Notified body examination of the type and full quality assurance of production
- Annex VII technical documentation is the examination basis; traceability is mandatory
- Regular surveillance by the notified body for the certified type
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.