CE marking step-by-step plan
Many products can be traded in the European Union if they have a CE marking. The CE marking indicates that the manufacturer takes responsibility for ensuring that the product meets all legal requirements in the areas of safety, health, the environment and other relevant areas.
Are you importing a product from outside the EU? Then you will probably be considered by the legislator as a manufacturer of the product. You are then responsible for applying the CE mark to the product, but more importantly, for the next 10 years you are fully responsible for the safety of the product and for retaining the mandatory technical file.
What is the minimum you must do before you apply the CE marking to your product?
The Précon Quality Services CE marking step-by-step plan includes the following 7 steps:
Point 1. Determine which guidelines and regulations apply to your product.
There are more than 20 directives and regulations, several of which may be relevant to your product.
Point 2. Determine the requirements for your product from every guideline and regulation found.
The guidelines and regulations specify the essential requirements that your product must meet. European harmonised standards have been drawn up for each directive and regulation. If your product meets these standards, you have "a presumption of conformity with the essential requirements". This is a statutory obligation that you must demonstrably comply with.
Point 3. Determine the correct conformity assessment procedure.
A number of possibilities have been identified for this in Europe. Which procedure is right for your product depends on your product and the guidelines and regulations that are relevant.
Point 4. Validate whether your product meets the applicable requirements.
By using product tests and risk assessments, you can assess whether your product meets the essential requirements of the relevant guidelines and regulations. You can use harmonised standards for testing.
Point 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 at least 10 years after the product has been put on the market.
Point 6. Draw up the Declaration of Conformity.
When the previous steps have been successfully completed, you as a manufacturer are required to draw up and sign the Declaration of Conformity. The exact content of this declaration depends on the requirements in the relevant guidelines and regulations.
Point 7. Apply the CE marking to your product.
As a final step, you must affix a visible, legible and indelible CE marking to your product. After this you can place your product on the European market.
We possess the expertise to support you in all these steps. If you are curious what we can do for you, please contact us for a free quote.
We will be happy to discuss with you the possibilities of supporting the CE marking process for your company. Feel free to contact us via the button below or call us on +31 (0)30 - 65 66 010.Make an appointment