CE markings label equipment that meets European Union Directives.
The CE marking is French for European Conformity. The CE mark indicates that the product has met European Union product directives. These product directives include medical products, safety equipment and environmental protection products. CE marking is required for industrial equipment like pressure vessels, personal protective equipment, noise control, medical devices, industrial measurement equipment and boilers. The CE marking is also required on telecommunication equipment and industrial machinery.
Instructions
Steps
1. Determine if you need CE marking before going through the effort to earn it.
Determine if the equipment requires CE marking. It is the manufacturer or importer's burden to determine if CE marking is required. European Union Directives of quality standards for the product will state whether the industrial equipment requires the CE marking.
2. Register the business or import firm with the European Union (EU) if it is not already registered. According to Safety of Electromedical Devices" by Norbert Leitgeb, "the manufacturer or his authorized representative must register himself and the marketed medical devices." This can be done online.
3. Fill out the Conformity Assessment Procedure form for your product to request CE marking certification. Refer to the European Union Directives for the correct form to use.
4. Gather the documentation for the product. This includes a user's manual and a list of any relevant warnings for users.
5. Submit the product along with its documentation to the independent test labs appointed by the European Union to approve products for the CE mark. Conformity Assessment Bodies in the United States can also perform this testing. The United States National Institute of Science and Technology (NIST) has a list of Conformity Assessment Bodies approved by the European Union to perform testing to qualify products for CE marking.
6. Save the verification of the testing from the lab that certifies that the industrial equipment meets EU standards. These results must be produced if the EU requires it.
7. Use the documentation and verification of testing to create a Declaration of Conformity. This will be used to label the equipment.
8. Label the industrial equipment with the CE marking. The lettering must be at least five millimeters tall unless an exemption is granted.
9. Submit the Declaration of Conformity with all shipments sent to the EU.
10. Store the Declarations of Conformity. These forms must be available upon request by EU authorities for at least five years after the last product is manufactured.
