The Declaration of Conformity supporting the CE marking of a Class I device does NOT include which of the following?

The Declaration of Conformity supporting the CE marking of a Class I device does NOT include which of the following?

• A. The signature of the Notified Body
• B. Identification of directives to which declaration is issued
• C. The manufacturer's name and address
• D. Product Information (name, type or model number)

Answer: (A)

The Declaration of Conformity supporting the CE marking of a Class I device does not require the signature of a Notified Body because Class I devices are generally considered lower-risk products that the manufacturer can declare conformity for on their own. This is in contrast to higher-risk classes of devices where oversight and validation by a Notified Body is necessary to ensure compliance with safety and performance requirements. In the case of Class I devices, manufacturers must provide details such as identification of the applicable directives, their own name and address, and specific product information including the name, type, or model number. These aspects are essential for clarifying the product’s compliance and ensuring that it meets the necessary regulatory standards. By omitting the Notified Body's signature from the Declaration of Conformity, it reinforces the notion that the manufacturer takes full responsibility for the conformity assessment of Class I devices.

The Declaration of Conformity supporting the CE marking of a Class I device does not require the signature of a Notified Body because Class I devices are generally considered lower-risk products that the manufacturer can declare conformity for on their own. This is in contrast to higher-risk classes of devices where oversight and validation by a Notified Body is necessary to ensure compliance with safety and performance requirements.

In the case of Class I devices, manufacturers must provide details such as identification of the applicable directives, their own name and address, and specific product information including the name, type, or model number. These aspects are essential for clarifying the product’s compliance and ensuring that it meets the necessary regulatory standards. By omitting the Notified Body's signature from the Declaration of Conformity, it reinforces the notion that the manufacturer takes full responsibility for the conformity assessment of Class I devices.