What does the Declaration of Conformity for a Class I device NOT include?

The Declaration of Conformity for a Class I device is an important document that certifies that a product meets the essential requirements of relevant European directives. This document serves as a declaration by the manufacturer or an authorized representative, not by the Notified Body (NB).

The Declaration of Conformity typically includes the manufacturer's name and address, which helps in clearly identifying the entity responsible for the product. Furthermore, it outlines the specific directives to which the declaration applies, ensuring that the requirements of the European regulatory framework are met. Additionally, it contains product information including the name, type, or model number, providing detailed identification of the device in question.

The signature of the Notified Body is not required for Class I devices unless the device is subject to third-party assessment. Class I devices generally fall under self-declaration by the manufacturer, making the inclusion of a Notified Body's signature unnecessary in this specific context. This distinction is crucial for understanding the regulatory expectations for different device classifications.