CE Marking: How to obtain the CE mark?

In order to be sold in the European Economic Area, or by its abbreviations, the EEA (formed by the EU plus Iceland, Liechtenstein and Norway), many products must necessarily bear the CE mark, which is proof that the product has been evaluated and meets the requirements of safety, health and environmental protection required by the EU. It is valid for products manufactured both inside and outside the EEA, whose commercialization is planned within it. If you want to put the CE marking on your product, you must gather the technical documentation that shows that you meet all the requirements demanded in the EU. As the manufacturer of the product, you are solely responsible for declaring your agreement with all of them. Once the product bears the CE marking, you may be required to provide your distributors or importers with all supporting documents. How to obtain the CE mark? The manufacturers in must follow a series of steps: 1. Identify the requirements applicable to your product at EU level Requirements at the EU level are set out in Directives that cover different products or sectors in, for example: • Toysrn• Electric equipmentrn• Machineryrn• Medical devicesrn• Elevatorsrn• Personal protective equipment. These Directives establish the essential requirements that products must meet. 2. Check if your product meets the specific requirements It is up to you to make sure that the product meets all the legal requirements at EU level. If there are harmonized European standards in relevant to your product and your company abides by them in the production process, it shall be presumed that the product complies with the relevant EU directives. 3. Check whether a notified body must test your product In the case of certain products, the so-called "notified bodies" (specific conformity assessment bodies) must check that their product meets the specific technical requirements. This step is not mandatory for all products. 4. Test your product If it is not necessary for an independent body to verify your product, it is up to you to verify that it meets the relevant technical requirements. This includes the estimation and documentation of the possible risks derived from the use of the product. 5. Gather the technical documentation The technical documentation of your product must include all documents that demonstrate that it meets the relevant technical requirements. 6. Place the CE marking and write the declaration of conformity Finally, you can put the CE marking on your products. The marking must be fixed so that it is visible, legible and indelible. If a notified body has had to intervene (step 3), the product must also include the identification number of that body. You must also draft and sign an EU declaration of conformity stating that your product meets all legal requirements. Importers While manufacturers are responsible for ensuring conformity and affix the CE marking, the importers in must ensure that products placed on the market comply with the applicable requirements and do not pose a risk to European consumers. The importer must verify that the manufacturer established outside the EU has followed the necessary steps and that the documentation is available if requested. Dealers The distributors in should have a basic knowledge of the legal requirements, including which products must bear the CE marking and accompanying documentation, and must be able to clearly identify products that do not comply. In addition, they must be able to demonstrate to the national authorities that they have acted with due diligence and that they have proof that the manufacturer or importer has taken the necessary measures. In addition, the distributor must be able to assist the national authorities in their efforts to receive the required documentation.