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Compliance with EU Directives

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Compliance with the "essential requirements" of a Directive can be achieved through a variety of methods -- self-declaration, type testing by a Notified Body, full quality assurance or other means. The methods of compliance available to a manufacturer are outlined in each particular Directive. Methods available in each Directive differ based on the perceived hazards involved for a type of product.

Achieving compliance through a Notified Body

A Notified Body is a third-party organization which has made notification to the Commission and which has been designated by a Member State which has chosen it from the Bodies under its jurisdiction.

A Notified Body meets the criteria of competence and performs functions relating to conformity such as standards-writing, testing, certification, and/or factory assessment.

Besides assisting manufacturers in complying with Directives, Notified Bodies play another important function in the European Union. Compliance with Directives will give a product legal access to the EU countries. However, in the marketplace, distributors, wholesale agents, retailers, and other involved parties may request verification of compliance through particular means such as third-party certification via a Notified Body.

Since third-party certification via a Notified Body is always an option for verifying compliance, utilizing a Notified Body can assist manufacturers in meeting both the legal as well as the market requirements that may be placed on a product. Manufacturers should research their customer base to determine market requirements.

Proper documentation

Regardless of the method used to achieve compliance with the essential requirements of a Directive, proper documentation is always a requirement. Documentation required is identified in each Directive.

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