NIST SP 951
A Guide to EU Standards and Conformity Assessment

The Declaration of Conformity must be kept for at least ten years from the last date of manufacture of the product, unless the directive provides for a different duration. For example, the Directives for Medical Devices and Active Implantable Medical Devices require that the Declaration of Conformity be kept for five years.

Directives for Machinery, Equipment for Use in Potentially Explosive Atmospheres, Recreational Craft, and Lifts require that the Declaration of Conformity accompany each product. It is highly recommended that a Declaration of Conformity be included with shipments of products that fall under other directives as well, although it is not necessary to include it with each product.

Language

The Declaration of Conformity must be in one of the official languages of the European Union (English is one of the official languages). For products that must be accompanied by a Declaration of Conformity (i.e., products covered by Directives for Machinery, Potentially Explosive Atmospheres, Recreational Craft, and Lifts), the Declaration of Conformity must be in the language of the country of use. It is recommended that the Declaration of Conformity that is required by directives other than the ones listed above also be in the language of the country where the product or equipment will be used.

Signature of Declaration of Conformity

The Declaration of Conformity must be signed by a person who is authorized to bind the company, as the Declaration is, in essence, a statement by the company. The person who signs should be one who has responsibility for determining that the design of the product is reasonably safe and has authority to direct changes to the design. It is not necessary for the signatory to be domiciled in the European Union.

The person who will be placing his signature on the Declaration of Conformity must act in good faith: i.e., he must be informed that anything stated on the document is believed to be correct. Everything stated on the Declaration is stated in good faith and can be backed up by a solid Technical File.

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Technology Services, Standards Services Division, Global Standards and Information Group Contact: maureen.breitenberg@nist.gov A Guide to EU Standards and Conformity Assessment, NIST SP 951

Date Created: 05/31/00 Last Modified: 05/31/00