Although the Declaration of Conformity is only required to be made available (by the manufacturer or his authorized representative) upon request by national surveillance authorities, it is better to include the Declaration with each shipment.

The Declaration of Conformity must contain:

• the product (name, type or model number, lot, batch or serial number);
• the name and address of the manufacturer or his Authorized Representative;
• the name and identification number of the Notified Body if required by the directive;
• standards or other normative documents applied to verify compliance with the directive(s). Declaration should also include reference to other directives if applicable;
• the date of issue; and
• the signature and title.

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