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CE Mark Compliance Testing

CE Mark Compliance Testing

The CE Mark or CE Certification is a mandatory conformance mark that certifies that a product has met EU consumer safety, health or environmental requirements. CE originally stood for “Communauté Européenne” or “Conformité Européenne”. The CE Marking is mandatory for certain product groups in the European Economic Area (EEA), consisting of the 27 Member States of the European Union (EU) and European Free Trade Association (EFTA) countries of Iceland, Norway and Liechtenstein. It is also obligatory for all products made in third countries (non-member states) which are sold in the EEA. In that case, the importer has to make sure that the manufacturer outside the EU has taken the necessary steps that allow him to affix the CE Marking. We have put together a list of countries that require the CE mark.

The CE Mark is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE Marking on a product, a manufacturer is declaring, on its sole responsibility, conformity with all of the legal requirements to achieve CE compliance and therefore ensuring validity for that product to be sold throughout the European Economic Area.

The CE Mark impacts manufacturers, importers and distributors as detailed below:

  • Manufacturers must complete a conformity assessment, set up a technical file and sign an EC declaration of conformity prior to affixing a CE Mark to its product. Products may only be placed on the market if they comply with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly.
  • Importers must verify that the manufacturer outside the EU has completed the required steps to affix a CE Mark to the product. Importers must also confirm that the CE Mark documentation is available upon request.
  • Distributors must be able to produce sufficient documentation confirming that the manufacturer and importer have completed all steps necessary to affix a CE Mark to a product.

The EU and UN established a certification requirement for motor vehicles. The E-Mark for Motor Vehicles is also known as UN Resolution 10/UNECE 10. Keystone works with companies to ensure compliance with this standard.

While the CE Mark EMC requirements might appear overwhelming, Keystone Compliance has streamlined the process serving manufacturers as a full-service third-party test and product compliance test laboratory.

The first step is a discussion so that Keystone can learn about the product, its characteristics, its applications and geographical market territory. During this conversation, the manufacturer also learns about the CE Mark process and information on the directive(s) that the product is required to meet.

Following the initial conversation and determination, Keystone Compliance schedules laboratory test time to determine that the manufacturer’s device complies with all of the EMC requirements of the directives that it is required to meet. Keystone Compliance’s engineers provide valuable feedback and guidance during the test process, offering engineering suggestions when needed. This value engineering significantly reduces test time and exponentially increases the likelihood of meeting the CE compliance test requirements.

Keystone Compliance can assist manufacturers with the following CE Mark Directives:

  • CE Mark Low Voltage Directive
  • CE Mark Electromagnetic Compatibility (EMC) Directive
  • CE Mark Machinery Directive
  • CE Mark Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of their Conformity
  • CE Mark Medical Device Directive

Upon completion of the CE Mark tests, Keystone Compliance completes a detailed test report that contains all of the test results and any corrective actions that might require attention. Upon compliance of the CE Mark directive EMC requirements, Keystone Compliance provides a Declaration of Conformity, in draft form, and instructions on the CE Marking. The CE Mark post certification process requires manufacturers to follow standards on each product and shipment.

Keystone Compliance assists manufacturers with CE Mark compliance. In some cases, manufacturers are capable of CE Mark Self Certification. Keystone can provide guidance throughout this process. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your CE Mark needs. To learn more, see our list of CE Mark Frequently Asked Questions.