How Do You Acquire CE Marking
There are a series of steps outlined below. Depending upon your product and the nature of the risks it presents, there are several alternatives also noted that may apply to your situation.
- Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
- Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
- Choose the conformity assessment procedure from the options called out by the directive for your product.
The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.
Options for products with minimal risk include self certification where the manufacturer prepares a declaration of conformity and affixes the CE Marking to their own product.
Options for products with greater risks can require tests, audits or additional certificates from a notified body.
- Select the applicable product standards and test methods for your product and select an independent lab If the product testing is to be done externally.
- Establish an authorized representative for regulatory affairs in the European Union for your product. Some directives require that a manufacturer designate in Europe a representative to produce technical documentation in a timely fashion when called upon to do so.
The directives require for many products that a technical file be prepared by the manufacturer. The technical file holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.
- Prepare a declaration of conformity that includes a list of the directives and standards that your product conforms to; product identification, the manufacturer's name, address and signature.
The declaration of conformity contains information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.
- Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. These rules address the size and location of the marking, affixing the CE Marking to products, packaging and material or documents shipped with the product, and specific limitations on when and who is permitted to affix the CE Marking.
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