Important product, Class I
Wearable products for health monitoring or for children
Examples:
Health trackers outside MDR/IVDR and wearable products for children
Conformity path:
Self-assessment only with full application of harmonised standards / EU certificate, otherwise notified body
Principle of core functionality (Art. 7 CRA)
The core function of the product category is decisive. Implementing Regulation (EU) 2025/2392 specifies technical descriptions; integrating a component alone does not replace assessing the core function of the overall product.