适用范围内的产品

适用范围内的产品

This Regulation applies to products with digital elements made available on the market, the intended purpose or reasonably foreseeable use of which includes a direct or indirect logical or physical data connection to a device or network.

Regulation (EU) 2024/2847, Article 2(1)

这是一组累积条件。产品名称、销售标签、行业类别或一张架构图，都不能单独决定结论。产品必须符合 CRA 定义，进入 Union market，并且在 intended purpose 或 reasonably foreseeable use 中包含相关连接。

• 产品：软件、硬件、单独投放市场的组件，或构成产品一部分的远程数据处理方案。
• 市场供应：产品在商业活动中，为分销或使用而提供到 Union market。
• 连接：产品的 intended purpose 或 reasonably foreseeable use 包含逻辑、物理、直接或间接数据连接。
• 排除：Article 2 或 delegated act 可以把本来满足条件的产品排除在 CRA 之外。

Product with digital elements

‘product with digital elements’ means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;

Regulation (EU) 2024/2847, Article 3(1)

这个定义覆盖完整产品，也覆盖单独投放市场的组件。软件不限于嵌入硬件的软件；硬件也不限于最终消费设备。用于集成的软件或硬件组件，如果单独投放市场，也可能本身就是 product with digital elements。

远程数据处理

‘remote data processing’ means data processing at a distance for which the software is designed and developed by the manufacturer, or under the responsibility of the manufacturer, and the absence of which would prevent the product with digital elements from performing one of its functions;

Regulation (EU) 2024/2847, Article 3(2)

远程数据处理不是用户能从产品访问的所有云服务。只有当相关软件由制造商设计、开发或由其负责，并且缺少该处理会使产品无法执行某项功能时，它才属于产品的一部分。

数据连接类型

‘logical connection’ means a virtual representation of a data connection implemented through a software interface;

Regulation (EU) 2024/2847, Article 3(8)

‘physical connection’ means a connection between electronic information systems or components implemented using physical means, including through electrical, optical or mechanical interfaces, wires or radio waves;

Regulation (EU) 2024/2847, Article 3(9)

‘indirect connection’ means a connection to a device or network, which does not take place directly but rather as part of a larger system that is directly connectable to such device or network;

Regulation (EU) 2024/2847, Article 3(10)

CRA 的连接概念宽于互联网访问。产品可以通过软件接口、主机系统、硬件端口、总线、线缆、光链路或无线电链路连接。产品也可以因运行在一个可连接设备或网络的更大系统中而形成间接连接。

常见例子包括：

• 直接逻辑连接：浏览器 HTTPS 会话、使用 IMAP 或 SMTP 的邮件客户端、API、管道、文件、网络套接字和其他软件接口。
• 间接逻辑连接：运行在联网操作系统上的离线计算器或文本编辑器。
• 物理连接：USB、以太网、光纤、现场总线、电气接口、光学接口、机械接口、Wi-Fi、蓝牙、NFC 和其他无线电链路。
• 没有相关连接：基础计算器、洗碗机控制器或简单玩具中的固件，如果 intended purpose 和 reasonably foreseeable use 不包含与其他设备或网络的数据连接。

市场供应

‘making available on the market’ means the supply of a product with digital elements for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

Regulation (EU) 2024/2847, Article 3(22)

价格不是决定因素。免费提供仍可能属于商业活动。首次在 Union market 上提供是 placing on the market；后续为分销或使用而提供，也属于 making available on the market。

仅供制造商自用的产品，与供应到 Union market 的产品不同。委员会 FAQ 举例说明，制造商自己使用的开发和配置工具不在适用范围内，除非这些工具作为单独产品投放市场。

Intended purpose 和 foreseeable use

‘intended purpose’ means the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;

Regulation (EU) 2024/2847, Article 3(23)

‘reasonably foreseeable use’ means use that is not necessarily the intended purpose supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation, but which is likely to result from reasonably foreseeable human behaviour or technical operations or interactions;

Regulation (EU) 2024/2847, Article 3(24)

Intended purpose 来自制造商自己的产品信息。Reasonably foreseeable use 防止制造商只用狭窄的声明用途排除正常的人类行为或技术交互。

产品边界例子

同一个产品族可能同时包含适用和不适用的情形。法律结论跟随定义，而不是跟随宽泛的商业类别。

不在适用范围内

Article 2 包含直接排除、通过 delegated act 的后续排除或限制，以及安全敏感信息披露规则。产品不会仅因属于某个行业而排除；必须符合具体 Union act、delegated act 或条款条件。