CE-Mark and Declaration of Conformity Procedures
Decide Which Directives Apply to Your Export Product
Directive examples include: Electromagnetic Compatibility, Electrical (Low-Voltage) Safety, Machinery Safety, Medical Devices, and Radio/Telecommunications Equipment. The equipment manufacturer identifies the proper directives that apply to a product. For example, if the product is equipped with moving parts, the machinery safety standard will apply.
GME is an ISO 17025 accredited laboratory testing products for compliance with the above directives. We use the latest international EMC/electrical safety standards and electronics specifications.
Decide Which Standards Apply and Perform Tests
After choosing the directives that apply, a manufacturer then selects the applicable harmonized (EN) product standards and performs the required tests. The IEC (International Electrotechnical Commission) writes many CE standards. GME is available to answer questions, as well as perform tests.
Declaration of Conformity
When a product is tested and determined to be in compliance with applicable standards, a Declaration of Conformity (DoC) is created in accordance with ISO/IEC 17050-1/2. Reports generated by the test lab, as well as design documentation, act as “supporting documentation” in validating the DoC. Test records, drawings, risk analysis, etc., and the DoC are held on file and made available at anytime for review by “competent authorities”. A copy of the DoC should be submitted to your distributor, representative, or importer in the EC. It is also good practice to include a copy of your DoC in your instruction manual.
To show proof of conformity, the EU makes it mandatory for the manufacturer to label the product with the CE mark. The label, “CE”, must be attached in an indelible manner, look like the CE at right, and be no less than 5-mm in dimension. Whether reduced or enlarged the proportions given above must be maintained. The marking should be affixed to the product, or if this is not possible, to the packaging, instructions for use, or warranty certificate.
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