Draft Details
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.
You may comment on any clause of this document. Simply enter the clause number, make your comment and your proposed changed text for each clause, subclause, paragraph, table or figure.
All comments are checked by a moderator before they are made public on the site. This is to ensure that improper language or marketing is not placed on the site – we will not judge or modify technical content. Similarly, we will not correct your grammar or spelling