CE Marks

If you plan on bringing a product to the European market, you've likely heard about the Conformite Europeenne (CE) marking. You might wonder if it applies to your product, how to go about obtaining this mark, or what happens if you don't comply with its requirements. These are common concerns for manufacturers, importers, and distributors. Ensuring your product meets European Union (EU) standards protects consumers and builds trust. 

This guide walks you through the process of obtaining a CE mark. 

What Is a CE Mark?

A CE mark is a certification symbol placed on products to indicate conformity with the EU's health, safety, and environmental protection standards. The CE mark allows products to move freely within the European Economic Area (EEA). It signals that the product meets all applicable EU regulations, which assures consumers and businesses that the item is safe and compliant. 

You'll typically find the CE mark printed on the product, its packaging, or accompanying documentation. Not all products require a CE mark, but certification is mandatory for certain item categories, including: 

• Medical devices
• Toys
• Machinery
• Electrical equipment 
• Construction products
• Personal protective equipment
• Pressure equipment
• Energy-related products

Importance of CE Marks 

CE marks are a measure of safety, trust, and market accessibility. Here's why you should get certification: 

• Meet legal requirements for market entry: If you plan to sell your products in the EEA, CE marking is necessary for applicable product categories. Certification gives your product access to EEA countries without additional testing or accreditation. 
• Ensure consumer safety and confidence: Consumers are increasingly aware of certifications and standards. The CE mark represents safety, reliability, and environmental consciousness. When a product carries this mark, it reassures consumers and regulatory bodies that it has been tested and complies with EU requirements. For manufacturers, this focus on safety and quality may translate into fewer returns, complaints, or liability issues. 
• Protect your business from legal and financial risks: Noncompliance with CE marking regulations can lead to hefty fines and product recalls. Such incidents can damage your brand's reputation and disrupt your supply chain. 
• Give your company a competitive edge: Since products with CE marks signal quality and adherence to international standards, it may give you a competitive advantage in global markets. 
• Strengthen your brand's reputation: CE marking shows that your business is committed to high safety and compliance standards. This commitment may improve your brand's reputation globally because many countries outside the EU also recognize the CE mark. 

CE Certification Process

The manufacturer, importer, or distributor is responsible for CE marking a product. Here are the steps to ensure your product is legally compliant for sale in the EEA. 

1. Identify Applicable EU Directives and Regulations

Check which EU directives or regulations apply to your product. Each directive outlines specific requirements based on the product category. 

For example: 

• A children's toy must comply with the Toy Safety Directive so it is free from choking hazards and toxic materials. 
• Electronic equipment must adhere to the Low Voltage Directive (LVD) and Electromagnetic Compatibility (EMC) Directive. 
• Medical devices fall under the Medical Devices Regulation (MDR), which governs simple bandages to diagnostic equipment. 
• Industrial machines, tools, and equipment fall under the Machinery Directive. 
• Personal protective equipment, like helmets, masks, and gloves, fall under the PPE Regulation. 
• Materials and products used in building construction must meet the Construction Products Regulations (CPR). 

If your product does not fall within the scope of a directive or regulation, it does not require a CE mark. However, you may need to comply with local or international standards. 

2. Confirm Essential Product Requirements

Once you've identified the relevant directives, the next step is understanding their vital requirements. These requirements are the specific safety, health, and environmental standards your product must meet to comply. For example, if you're manufacturing electrical equipment, the main prerequisites might include testing the electrical safety, resistance to overheating, and electromagnetic compatibility. 

3. Choose a Conformity Assessment Procedure

The path to getting a CE certification depends on your product's risk level. EU directives outline conformity assessment procedures manufacturers can follow: 

• Self-certification: If you have low-risk products, you can assess compliance independently by conducting in-house testing and creating the required documentation. 
• Notified body involvement: High-risk products will require a notified body — a third-party organization appointed by the EU — to verify compliance. This process typically involves external testing, inspections, and certification. 

4. Conduct Product Testing

Testing your product against applicable harmonized standards is a vital step. Harmonized standards are technical specifications recognized by the EU as benchmarks for compliance. For example, a smartphone must be tested for electromagnetic interference to comply with the EMC directive. A power tool might undergo testing for electrical insulation and vibration safety under the Machinery Directive. 

You can test in-house if you have the necessary facilities, but some manufacturers might use accredited testing laboratories for accuracy and impartiality. 

5. Compile a Technical File

A technical file is a detailed document that contains steps taken toward compliance. You must keep this file for the duration determined under the specific product directive or regulation. The file must include: 

• A comprehensive product description and design specifications. 
• Test reports and risk assessment findings. 
• Instructions for use, safety warnings, and labeling details. 

6. Affix the CE Mark 

Once you've completed the steps above, you can affix the CE mark to your product. The mark must: 

• Be clearly visible and easily readable.
• Be applied directly to the product, if possible, or on its packaging or accompanying documentation. 
• Follow the exact proportion specified in EU guidelines to avoid distortions. 

7. Draft the Declaration of Conformity

The declaration of conformity (DoC) is a formal statement you sign to declare that your product satisfies all relevant EU directives and regulations. This document should include: 

• Your company name and address. 
• A detailed description of the product. 
• A list of applicable directives and harmonized standards. 
• The date of issue and the name of the authorized signatory.
• Notified body details (if applicable).

EU authorities conduct regular market surveillance to ensure products continue to meet compliance standards. If you modify your product, you may need to reassess compliance and update your documentation. 

Contact Astrodyne TDI for CE Marking Tests

Astrodyne TDI specializes in EMI pre-compliance testing and CE certification support. With our fully equipped labs and experienced engineers, we'll ensure your products meet necessary EMC safety standards. We provide rigorous testing and handle all the complexities to ensure your product is compliant and prevent the bottlenecks associated with retesting or recertification.

By partnering with us, you'll save time, reduce costs, and gain the confidence that your products are fully compliant and ready for the European market. Let us help you find a solution. Contact us today to learn more.