Introduction
CE marking is an important requirement for many products sold in the European Union (EU) and European Economic Area (EEA). It demonstrates that a manufacturer has assessed the product and determined that it meets the applicable European requirements for safety, health, and environmental protection. However, CE marking is not a single certificate issued by an EU authority. The manufacturer is generally responsible for ensuring that the product meets all applicable requirements. Understanding the correct process can help businesses place compliant products on the European market more confidently.
Identify Whether CE Marking Applies
The first step is to determine whether your product falls under EU legislation that requires CE marking. Not every product needs a CE mark, so businesses should identify the legislation applicable to their specific product before beginning the conformity process.
Different product categories can be covered by different EU directives or regulations. For example, requirements may apply to machinery, medical devices, toys, electrical and electronic products, personal protective equipment, pressure equipment, and other regulated products.
Once the applicable legislation has been identified, manufacturers should determine the essential requirements that their product must satisfy. Relevant harmonised European standards can also help manufacturers demonstrate conformity with applicable requirements.
Complete the Required Conformity Assessment
After identifying the applicable requirements, the manufacturer must determine the appropriate conformity assessment procedure. The procedure depends on the product and the legislation covering it.
For some products, manufacturers may be permitted to assess conformity themselves. Other products require the involvement of an independent third party known as a notified body.
Where testing or third-party assessment is required, the manufacturer should ensure that the selected notified body is authorised to perform the relevant conformity assessment for the specific product and applicable legislation.
The assessment may involve product testing, examination of technical information, inspections, or evaluation of the manufacturer’s quality procedures, depending on the applicable requirements.
Prepare Technical Documentation and Declaration
Manufacturers must create technical documentation that demonstrates how their product meets the relevant EU requirements. This documentation should contain sufficient evidence to support the conformity assessment.
Depending on the product, technical documentation may include product descriptions, drawings, specifications, risk assessments, test reports, applied standards, instructions, and other relevant information.
The manufacturer must also prepare an EU Declaration of Conformity. By signing this declaration, the manufacturer takes responsibility for the product’s compliance with the applicable EU legislation.
Technical documentation and the Declaration of Conformity should be maintained for the period specified by the applicable legislation.
Affix the CE Marking Correctly
Once the required conformity assessment has been completed and the necessary documentation is prepared, the manufacturer can affix the CE marking to the product.
The CE marking should generally be visible, legible, and permanent. It is normally placed directly on the product, although packaging or accompanying documents may be used when the nature of the product does not allow the mark to be placed directly on it.
If a notified body is involved and the applicable legislation requires its identification number, the notified body’s four-digit number must appear with the CE marking.
Conclusion
Getting CE marking involves more than simply placing a CE logo on a product. Manufacturers must first identify the applicable EU legislation, determine the appropriate conformity assessment procedure, complete the necessary testing or assessment, prepare technical documentation, and issue the EU Declaration of Conformity. Once these requirements have been satisfied, the CE marking can be affixed appropriately. Because requirements differ between product categories, businesses should carefully determine the rules applicable to their specific products before placing them on the European market.