Obtaining a CE Marking on a piece of equipment involves completing a process prescribed by the European Union as part of a larger strategy to implement consistent standards. A CE Marking on a piece of equipment or device signifies that a manufacturer has complied with all applicable EU Directives that relate to the design, materials, manufacture and distribution of the equipment. The procedure must be completed by companies that intend on selling products into the EU.
History
The focus and implementation of standardized procedures that meet the needs of all member nations of the European Union is embodied by the CE Marking requirements. These regulations were established in 1991 as a way to protect citizens of the EU from possible harm resulting from equipment or devices used in the workplace. The guidelines are broken into two distinct parts. The first part establishes regulations for the "safety of machinery" while the second part provides "technical principles and specifications." (see Reference 1) Full implementation of the directive took a number of years to accomplish but CE Marking is now recognized by much of the world as a symbol of quality, reliability and safety.
Some confusion exists regarding the proper terminology. Many terms are used interchangeably to refer to this certification such as "CE Mark," "CE Certificate," or "CE Stamp." The proper term for this standard as adopted by the European Union in 1993 is "CE Marking." (see Reference 2) Using the proper term is important for conducting research and for communicating properly regarding the process.
Requirements
Obtaining a CE Marking is required if a product has been identified by an EU Directive used in the verification process. All other products are governed by General Product Safety Directive (92/59/EEC). All manufacturers that make products covered by CE Marking Directives must follow certain specific steps, namely: identifying applicable directives, complying with EU standards, maintaining relevant paperwork, signing a Declaration of Conformity, and affixing the CE Marking.
The aforementioned steps represent the core requirements but do not include additional steps that may be required depending on the equipment in question and the applicable Directives. By completing each step in the process the manufacturer moves closer to the ultimate goal of obtaining the CE Marking. Without this certification the markets of the 27 member countries of the European Union are closed to the manufacturer so it is in the interest of companies to complete the process expeditiously.
Procedure Guidelines
Manufacturers are responsible for completing each step on their own therefore many companies engage the services of experts that can shepherd products through certification. Interestingly it is not required to pay a third party to obtain the CE Marking but in many cases making sense out of the regulations and identifying all of the relevant Directives is a challenge. More than 100 Directives have been established each with its own details for design requirements, material standards, procedures and regulations designed to assure work place safety and environmental protection. Some of the Directives apply to specific products like appliances burning gaseous fuels or construction products while others are designed to address broader issues such as liability and safety. The Directives carry the force of law so manufacturers must comply with every aspect.
To obtain CE Marking manufacturers must identify and demonstrate conformance with all of the Directives that apply to their equipment. All of the components must meet specifications ranging from electrical frequency to the biodegradable aspects of the materials. In many cases manufacturers are allowed to validate their own equipment while in other cases an officially designated body called a "Notified Body" must be engaged to validate materials through procedures that have been defined by official EU agencies. Records of all requirements established by the applicable Directives must be maintained and combined with a Declaration of Conformity. Once these steps have been satisfied the manufacturer must assure compliance with any additional guidelines or regulations established by the individual nations in which the product will be sold. After all Directives and requirements have been met the manufacturer is permitted to affix the CE Marking.
Time Frame
Getting a product qualified to receive a CE Marking can be a time consuming process that may take many months or more than a year. The time requirements are greatly influenced by the number of applicable Directives that govern a product as well as the complexity of the product itself. Another factor that extends the time is the comprehensive nature of the certification. CE Marking governs not only the product itself but applies to the design as well. Complying with design requirements may require significant changes thus extending the certification time line. Estimating the time required to obtain a marking includes factoring in the aforementioned steps and calculating the time necessary to meet the requirements of individual EU nations.
Considerations
As a manufacturer completes the process they must keep and maintain detailed records that are part of ongoing requirements. All modifications and updates to a device must be viewed against requirements included in various CE Marking Directives. In many cases the ongoing nature of the compliance requirements involves implementation of an entire process within a company that manages the required documents and assures that company products remain compliant. Some companies opt to hire a specialist in this area who maintains the appropriate materials and remains abreast of changes in EU policy that impact the company's products bearing a CE Marking. Other companies outsource this process. The point to remember is that the CE Marking process is a living and ongoing procedure that requires maintenance and upkeep. Assuring that company products remain current with the EU requirements is important because the step is required for continued access to the markets of the 27 nations that make up the EU.
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