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CE-markeringstappenplan.

Many products may be traded in the European Union if they have a CE mark. For those products, the CE mark indicates that the manufacturer takes responsibility and that the product meets all legal requirements in the areas of safety, health, environment and other relevant areas.

Are you importing a product from outside the EU? Then you are likely to be designated by the legislature as the manufacturer of the product. You are then responsible for affixing the CE mark on the product, but more importantly, you are fully responsible for the safety of the product for the next 10 years and for having the mandatory technical file available.

CE-Markeringstappenplan.

Are you importing a product from outside the EU? Then you are likely to be designated by the legislature as the manufacturer of the product. You are then responsible for affixing the CE mark on the product, but more importantly, you are fully responsible for the safety of the product for the next 10 years and for having the mandatory technical file available.

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At a minimum, what should you do before you CE mark your product ?

Our CE marking roadmap consists of the following 7 steps:

Step 1. Determine which guidelines and regulations apply to your product.

There are more than 20 guidelines and regulations, several of which may be relevant to your product.

Step 2. From each guideline and regulation found, determine which requirements apply to your product.

Directives and regulations specify the essential requirements your product must meet. European harmonized standards have been drawn up for each directive and regulation. If your product meets these standards then you have "a presumption of conformity with the essential requirements." This is a legal obligation that you must demonstrate compliance with.

Step 3. Determine the appropriate conformity assessment procedure.

A number of options for this have been established in Europe. Which procedure is right for your product depends on your product and the directives and regulations that are relevant.

Step 4. Validate whether your product meets the applicable requirements.

By using product testing and risk assessment, you can assess whether your product meets the essential requirements of the relevant directives and regulations. For testing, you can use harmonized standards.

Step 5. Compile the technical file.

This includes a product description, drawings, an overview of applied standards and specifications, test reports, instructions and the Declaration of Conformity. You must keep the technical file for at least 10 years after the product is put on the market.

Step 6. Draft the Statement of Compliance.

When the previous steps have been successfully completed, you as the manufacturer must prepare and sign the Declaration of Conformity. The exact content of this declaration depends on the requirements in the relevant directives and regulations.

Step 7. Apply the CE mark to your product.

As a final step, you must affix a visible, legible and indelible CE mark on your product. After this, you may place your product on the European market.

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