CE: Many products require CE Marking before they can be sold in the EEA ( EU + Iceland, Lichtenstein and Norway). CE Marking proves that your product has been assessed and meets EU Safety, Health and Environmental protection requirements. It is valid for products manufactured both inside and outside the EEA, that are then marketed inside the EEA.

To affix the CE Marking to your product, you must put together a technical dossier proving that your product fulfils all the EU-wide requirements. As the product’s manufacturer, you bear sole responsibility for declaring conformity with all requirements. Once your product bears the CE Marking, you might have to provide your distributors and/or importers with all the supporting documentation concerning CE marking.

How to obtain CE marking?

  • Identify the EU requirements for your product
  • Check whether your product meets the specific requirements
  • Check whether your product must be tested by a Notified Body
  • Test your product
  • Compile the technical dossier
  • Affix the CE marking and draft a declaration of conformity

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.

Minimal Risk

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.

Greater Risks

Many directives require products/systems with greater risks to be independently certified; this must be done by a “Notified Body”. This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union.

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