Declaration of conformity

It shall contain at least the following information:

• Trade name or registered trademark of the manufacturer and its address or registered office for contact purposes.
• Affirmation that the statement is issued under your sole responsibility.
• The Basic UDI-DI .
• Name and trade name of the product, code or other unequivocal reference that allows the identification and traceability of the product, as well as its intended purpose.
• Risk class of the product.
• Affirmation that the product is in compliance with the applicable legislation.
• References to the common specifications used.
• Name and identification number of the Notified Body (ON), description of the conformity assessment procedure and identification of the certificate issued by the ON.
• Supplementary information, if applicable.
• Place and date of issuance of the declaration, name and position of the person who signed it, together with his or her own signature.

The declaration of conformity is part of the documents that must be delivered to the user by the manufacturer, and it is the responsibility of the Technical Manager to ensure that this is the case.