NIST SP 951
A Guide to EU Standards and Conformity Assessment

The Importer

An importer is a person legally established within the European Union who places a product from a country outside the European Union on the European Union market. Although the importer can provide the Surveillance Authority with the necessary documentation or information regarding a product when the manufacturer is not established in the European Union and the manufacturer has no Authorized Representative, he or she may not wish to assume this responsibility. The decision is declared in a contract between the importer and the manufacturer.

Private Labeler

In accordance with European product liability legislation, a person acting as the manufacturer of the product, even if he or she is not the producer, is considered a manufacturer in the eyes of the law. This principle applies to the "private labeler." A private labeler is one who does not manufacture the product, but places it on the market under his or her private name or make. The "private labeler," therefore, as manufacturer, is ultimately responsible for compliance with all requirements.

Authorized Representative

An Authorized Representative is the person appointed by the manufacturer and delegated to act on his or her behalf in carrying out certain tasks required by a New Approach Directive. This Authorized Representative must be established inside the European Union and available to Member State Authorities. The manufacturer, however, is ultimately responsible for the actions carried out by the Authorized Representative.

Manufacturers established outside the European Union are not necessarily required to have an Authorized Representative in the European Union. There are exceptions, however. Manufacturers who do not have a registered place of business in a Member State and whose products are governed by the Directives for Medical Devices, Active Implantable Devices and In-vitro Diagnostic Devices, must appoint an Authorized Representative established within the European Union.

The delegation of tasks from the manufacturer to the authorized representative should be arranged by contract.

Depending on the conformity assessment procedure and the directive, the following tasks can be delegated to the Authorized Representative. He or she can:

• declare that the product complies with the requirements;
• affix the CE marking;
• draw up and sign the Declaration of Conformity; and
• keep the Declaration of Conformity available for national surveillance authorities.

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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