Annex III, Class I (19)
Personal wearables for health monitoring or for use by children
Health & children's wearables are important product, class i under Regulation (EU) 2024/2847 when the listed function is the product's core functionality. Health data is special-category personal data and children's devices carry location and communication features; both warrant heightened scrutiny.
Updated 2026-09-12 · Operational guidance, not legal advice.
- Classification
- Important product — Class I
- Conformity route
- Self-assessment only with fully applied standards
- Reference
- Annex III, Class I (19) · Art. 32(2)
What the annex says
Personal wearable products to be worn or placed on a human body that have a health monitoring (such as tracking) purpose and to which the medical device regulations do not apply, or personal wearable products intended for the use by and for children.
Paraphrase of Annex III, Class I (19); the Official Journal text governs.
Typical products in this category
- Fitness and sleep trackers
- Smartwatches marketed for wellbeing metrics
- Children's smartwatches and trackers
Where the boundary runs
Devices regulated as medical devices (MDR/IVDR) are outside this category and, for most requirements, outside the CRA. General smartwatches without a health-monitoring purpose are default products.
The test is core functionality (Article 7). Record the reasoning and the approver: the category determines the conformity assessment route and market surveillance authorities can challenge it.
Conformity assessment
Self-assessment only with fully applied standards. Module A is permitted only where harmonised standards, common specifications or a European cybersecurity certification scheme are applied in full; otherwise EU-type examination (Module B) followed by conformity to type (Module C), or full quality assurance (Module H). (Art. 32(2))
What to prepare operationally
- Include the companion app and the cloud service in the product boundary.
- Document sensor-data protection and pairing security.
- Define incident severity criteria for location and health-data exposure.
- Maintain an SBOM per released version, match it continuously against vulnerability intelligence, and keep the Article 14 runbook rehearsed — these apply to every product with digital elements, listed or not.
Frequently asked
- Is every health & children's wearables product an important product — class i?
- Only where the listed function is the product's core functionality (Article 7). Devices regulated as medical devices (MDR/IVDR) are outside this category and, for most requirements, outside the CRA. General smartwatches without a health-monitoring purpose are default products.
- What changes compared with a default product?
- Module A is permitted only where harmonised standards, common specifications or a European cybersecurity certification scheme are applied in full; otherwise EU-type examination (Module B) followed by conformity to type (Module C), or full quality assurance (Module H). The essential requirements of Annex I, the vulnerability-handling duties and Article 14 reporting apply to every product with digital elements regardless of category.
- From when?
- Article 14 reporting obligations have applied to all manufacturers since 11 September 2026. Conformity assessment and CE marking under the CRA apply from 11 December 2027; products placed on the market before that date are not required to be re-assessed unless substantially modified.