CE conformity refers to the process of ensuring that a product meets the essential health, safety, and environmental requirements set by the European Union (EU) to be legally sold and distributed within the European Economic Area (EEA). The acronym “CE” stands for Conformité Européene, which means European Conformity in French.
CE conformity is primarily applicable to products falling within the scope of the EU’s New Approach Directives. These directives cover various product categories, including machinery, electrical equipment, medical devices, toys, personal protective equipment, and many others.
To obtain CE conformity, the manufacturer or the authorized representative must follow a series of steps and fulfill specific obligations. These typically involve:
1 Identifying the applicable directives: Manufacturers need to determine which EU directives are relevant to their product based on its intended use and characteristics.
2 Conformity assessment: This involves assessing the product’s conformity with the essential requirements of the applicable directives. The process may include testing, documentation review, quality control measures, or involvement of a notified body (a third-party conformity assessment organization) for certain product categories.
3 Compilation of technical documentation: The manufacturer must create and maintain comprehensive technical documentation that demonstrates how the product meets the essential requirements of the directives. This documentation should cover aspects such as design, manufacturing, performance, risk assessment, and compliance with relevant standards.
4 Affixing the CE marking: If the product successfully demonstrates conformity, the manufacturer or authorized representative can affix the CE marking on the product, packaging, or accompanying documents. The CE marking indicates that the product complies with applicable EU requirements.
CE conformity is self-declared by the manufacturer or their authorized representative, and they assume responsibility for the conformity of the product. Market surveillance authorities within the EU member states are responsible for ensuring compliance and taking appropriate measures in case of non-compliance.
It’s important to note that CE conformity is specific to the EU and does not imply compliance with regulations in other regions or countries. Contact us today!
