CE marking, short for "Conformité Européenne" (French for "European Conformity"), is a mandatory symbol that indicates a product complies with the European Union's health, safety, and environmental protection standards. This marking is essential for products sold within the European Economic Area (EEA). By affixing the CE mark, manufacturers declare that their products meet all applicable EU directives and regulations, allowing for the free movement of goods across EEA countries. It's important to note that the CE mark is not a quality indicator or certification mark; rather, it signifies legal compliance with EU legislation.
The CE marking process involves several key steps to ensure that a product complies with European Union (EU) regulations and can be legally sold within the European Economic Area (EEA). Here's a step-by-step breakdown:
Determine which EU directives or regulations apply to your product. Each directive outlines specific requirements related to safety, health, and environmental protection. For example, medical devices are governed by the Medical Devices Directive (MDR 2017/745).
Understand the essential requirements stated in the applicable directives. This may involve conducting a risk analysis and ensuring your product meets performance and safety standards.
Decide whether your product requires assessment by a Notified Body—a third-party organization authorized by the EU to evaluate product conformity. Not all products need this; some can be self-assessed by the manufacturer.
Perform necessary tests to verify that your product meets EU requirements. Depending on the product and applicable standards, this testing can be done by an ISO 17025 accredited laboratory.
Gather comprehensive documentation detailing your product's design, manufacturing process, and compliance with relevant standards. This technical file should include:
Prepare a document in which you, as the manufacturer or authorized representative, declare that the product complies with all relevant EU directives. This declaration must include:
Once all the above steps are satisfactorily completed, affix the CE marking to your product. Ensure the marking is:
By following these steps diligently, manufacturers can ensure their products meet EU standards and are eligible for sale within the EEA.