Compliance with EU Directives
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 European Commission and 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. The required documentation is identified in each Directive.
