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The present document specifies technical requirements and corresponding assessment criteria for personal wearable
products that have a health monitoring purpose or that are intended for the use by and for children, related to
cybersecurity. The products with digital elements in scope, thereafter "personal wearable":
• are specified within the "technical description" of the "category of product" number "19" by the Commission
Implementing Regulation (EU) 2025/2392 of 28 November 2025 [i.2] as:
"Personal wearable products to be worn or placed on a human body that have a health monitoring (such as
tracking) purpose and to which Regulation (EU) 2017/745(2)or (EU) 2017/746 of the European Parliament
and of the Council do not apply, or personal wearable products that are intended for the use by and for
children".
• are only covered within the product context described in clause 4.
The present document covers those products to demonstrate compliance with essential cybersecurity requirements in the
Regulation (EU) 2024/2847 [i.1] Annex I Part I under the conditions identified in Annex A.