Who Is Responsible For Ce Marking
CE marking, a certification mark that signifies adherence to health, safety, and environmental protection standards, is of paramount importance for products sold within the European Economic Area (EEA).
This marking is not just a formality, but a crucial tool that manufacturers and importers wield to ensure the safety and of their products, enabling the free movement of goods across EEA countries.
The onus of ensuring CE marking compliance primarily rests with the manufacturers. They are tasked with determining whether their products necessitate adherence to the CE marking requirements. If so, they bear the responsibility of conducting the conformity assessment, establishing the technical file, issuing the EU Declaration and affixing the CE mark to their products.
For products manufactured outside the EEA, the role of the importer is crucial. They must ensure that the manufacturer has taken all necessary steps and that the product meets the CE requirements. Importantly, if an importer markets a product under its own name, it assumes all the responsibilities of the manufacturer, including ensuring compliance with the necessary requirements and applying the CE marking. This underscores the gravity of their role in the CE marking process.
Depending on the type of product, the conformity assessment — an essential part of the CE marking process — can sometimes be performed by the manufacturers themselves. This self-assessment happens for less critical product categories.
However, for more risk-prone categories, this assessment must be carried out by an external body, specifically an institution that is recognized and approved by the relevant regulatory authorities.
CE marking is a mandatory conformity, creating a mark for products placed on the European Economic Area (EEA) market. It indicates that a product has assessed by manufacturer deemed to meet EU safety, and environmental protection requirements. CE marking is only required for products that fall under the scope of specific EU directives stipulating its use. In cases where multiple EU directives or regulations govern a product, it is all applicable requirements before the CE marking is affixed.
Importantly, it is not just a matter of best practice, but it is illegal to place the CE mark on products for which no EU specifications exist or for which the regulations do not require the marking. This ensures that only products that have fulfilled EU compliance can circulate freely within the EEA, maintaining safety and standardization across member countries.
The responsibility for designing and producing a product, with the intention of placing it in the market under the manufacturer’s own name, falls squarely on the manufacturer. This includes ensuring good product meets all relevant EU regulations and directives.
If someone alters the product’s intended use in a way that affects its compliance with these essential requirements, the responsibility for ensuring compliance shifts to that party. Notably, the New Approach Directives/Regulations do not specify that the manufacturer must be located within the European Union.
Therefore, the responsibilities laid out in these directives apply equally to manufacturers both inside and outside the EU. This framework ensures that all products, regardless of the location of their manufacture, meet the same standards of safety and quality before entering the EU market.
