What type of information is included in a device's declaration of conformity?

The correct choice highlights that a device's declaration of conformity includes an attestation that the device meets EU regulatory requirements. This document is a formal statement from the manufacturer affirming that the device complies with all relevant European Union directives and regulations, such as the Medical Devices Directive (MDD) or the In Vitro Diagnostic Medical Devices Directive (IVDD). It signifies the manufacturer's commitment to adhering to safety and performance standards established by EU legislation.

The declaration of conformity serves as a key component in the conformity assessment process, which is essential for obtaining CE marking for medical devices. By providing this attestation, the manufacturer not only demonstrates compliance but also assures regulatory authorities and customers that the product meets necessary safety, health, and environmental protection requirements.

In contrast, the other choices do not accurately reflect the purpose of the declaration of conformity. While summary of distribution channels and details about packaging design may be important for the overall marketing and quality management of the device, they are not part of the declaration itself. Similarly, although listing potential risks is crucial for a comprehensive understanding of device safety, this information would typically be included in the device's risk management file or product label, rather than in the declaration of conformity.