CRA compliance for Smart wearable
Important class II (Annex III)
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 Important class II (Annex III) means for this product
Important class II products sit in the higher-risk half of the Annex III list. Conformity assessment generally requires third-party involvement: an EU-type examination by a notified body (Module B) followed by conformity to type (Module C), or a full quality assurance route (Module H). The technical documentation under Annex VII is the basis for that examination, so its completeness and traceability to the product state matters directly.
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 (Module B+C) or full quality assurance (Module H), notified body required
Annex III / IV structure
Annex III, Class II (Regulation (EU) 2024/2847, Art. 32(3))
The Regulation's own structure names these 4 categories in Annex III, Class II:
- hypervisors and container runtimes supporting virtualised execution of operating systems
- firewalls, intrusion detection or prevention systems used for security purposes
- tamper-resistant microprocessors
- tamper-resistant microcontrollers
This is the Regulation's own structure (Regulation (EU) 2024/2847, Annex III Class II), not an assessment of any specific product. Whether a particular product falls within a named category is the manufacturer's guided questionnaire answer, never an assumption of this site.
Key obligations
- Third-party conformity assessment via a notified body before placing on the market
- EU-type examination certificate, then conformity to type for each production unit
- Annex VII technical documentation complete and traceable to the assessed type
- Ongoing surveillance of the certified type where the module requires it
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.