具有健康监测用途的个人可穿戴产品
佩戴于身体、持续感测并处理健康相关信息的可穿戴产品。
类别解释
Personal wearable products to be worn or placed on a human body with a health monitoring purpose
佩戴于或置于人体、具有健康监测用途的个人可穿戴产品，是指直接或通过衣物、配饰佩戴在身体上，能够定期或持续感测并进一步处理与使用者健康相关的信息（包括身体指标）的数字要素产品，但不包括属于第（EU）2017/745 号或第（EU）2017/746 号法规适用范围的产品。本类别还包括拟供儿童使用的个人可穿戴产品，包括但不限于健身追踪器、智能手表、智能首饰、智能服装和运动服饰。
English
Personal wearable products worn or placed on the body with a health monitoring purpose are products with digital elements worn directly or via clothing or accessories that can regularly or continuously sense and further process information relevant to the user's health, including body metrics; products falling within Regulation (EU) 2017/745 or (EU) 2017/746 are excluded. The category also covers personal wearables intended for children and includes fitness trackers, smart watches, smart jewellery, smart clothing and sportswear.
CRA 附件三 I 类，技术描述见实施条例 (EU) 2025/2392 附件一第 1–19 项
Class I of Annex III to the CRA, with technical descriptions in Annex I, points 1–19, of Implementing Regulation (EU) 2025/2392
制造商可采用协调标准（或技术规范）证明符合性，据此完成内部合格评定；未适用协调标准时，须按模块 B+C 或模块 H 由公告机构参与评定。
Manufacturers may demonstrate conformity through harmonised standards or technical specifications and self-assess; where no harmonised standard is applied, Module B+C or Module H with a notified body applies.
重要产品 · I 类的主要义务
在默认类别要求基础上，针对该类别核心功能落实更严格的安全设计与默认安全配置。
按所选路径完成合格评定，保留技术文档、风险评估与测试证据以备市场监管核查。
建立结构化的漏洞处理流程，并在支持周期内持续发布安全更新。
English
- On top of the baseline obligations, apply stricter secure-by-design and secure-by-default measures for the core functionality.
- Complete the conformity assessment on the chosen route and keep technical documentation, risk assessments and test evidence for market surveillance.
- Operate a structured vulnerability handling process and release security updates throughout the support period.