The CE marking, derived from the French term "conformité européenne," signifies a product's compliance with European health, safety, and environmental protection standards. It is a mandatory requirement for products sold in the European Economic Area (EEA), which includes the EU member states, as well as Iceland, Liechtenstein, and Norway. The CE mark is not a quality certification mark but indicates that a product meets the essential requirements of applicable European directives.
Purpose of CE Marking
CE marking acts as a passport for products entering the European marketplace, allowing them to be sold without barriers across the EEA. It assures consumers and regulatory bodies that the product adheres to stringent health and safety requirements.
Key Requirements for CE Marking
Countries Requiring CE Marking
CE marking is a legal obligation for specific products intended for sale in the EU, European Free Trade Association (EFTA) countries, and Turkey. Producers within these regions, as well as importers of foreign products, must ensure their goods conform to EU standards.
After Brexit, the UK introduced the UKCA marking as an equivalent to CE marking for products sold in Great Britain. However, products marked with CE can still be sold until January 1, 2023. Northern Ireland, aligned with the European Single Market, continues to require CE marking, though UKCA marking may also be applied.
CE Marking and Central European Free Trade Agreement (CEFTA)
As of 2019, CE marking is not mandatory for CEFTA countries, such as Serbia, Albania, Montenegro, and North Macedonia. However, these nations are gradually aligning their standards with EU regulations as they pursue EU membership.
Documentation Required for CE Marking
To secure CE marking, manufacturers must compile a comprehensive set of documentation known as the Technical File. This file serves as proof of the product's conformity to CE-marking legislation and should be readily available for inspection by market surveillance authorities.
Components of the Technical File
- Technical Description: Detailed information about the product, including its design and intended use.
- Circuit Diagrams, Drawings, and Photos: Visual representations of the product's components and assembly.
- Materials Bill: A list of all materials used in the product, including specifications and standards.
- Design Calculations: Documentation that supports the design choices made for the product.
- Test Reports: Results of any assessments or tests conducted to validate compliance with relevant standards.
- EU Declaration of Conformity: A formal statement declaring the product meets all necessary requirements.
- Instructions for Use: Guidelines for safe and effective use of the product.
Steps to Obtain CE Marking
- Identify Applicable Directives
The first step is to determine whether your product requires CE marking by identifying the relevant sectoral directives. Over 20 directives may apply to products such as machinery, electrical items, medical devices, and toys.
- Pinpoint Relevant Requirements
Each directive contains essential requirements that products must meet. Compliance can often be demonstrated through harmonized standards, which provide a presumption of conformity.
- Choose an Appropriate Route to Conformity
Depending on the product's classification and associated risks, manufacturers must select a conformity assessment procedure. These can include:
- Self-Certification: For lower-risk products, allowing manufacturers to declare conformity independently.
- Third-Party Assessment: For higher-risk products, requiring evaluation by a Notified Body.
- Conduct a Conformity Assessment
Once the applicable directives and requirements have been identified, manufacturers must evaluate their products against these standards. This may include testing and assessment to ensure compliance.
- Prepare Technical Documentation
Manufacturers must compile the Technical File, which documents conformity with the relevant directives.
- Make a Declaration of Conformity
Upon successful assessment, manufacturers must complete an EU Declaration of Conformity, which includes:
- Manufacturer's name and address
- Description and serial numbers of the products
- List of applicable directives
- Statement of compliance with requirements
- Name and signature of the responsible person
- Affix the CE Mark
The final step is to affix the CE marking to the product, indicating compliance with all applicable directives.
Role of Notified Bodies
Notified Bodies are independent organizations designated by EU member states to assess conformity. They play a critical role in ensuring products meet the required safety and health standards.
Responsibilities of Notified Bodies
- Conduct assessments and audits
- Maintain transparency and impartiality
- Ensure confidentiality of the information obtained during assessments
- Provide detailed reports to manufacturers and relevant authorities
General Traits of CE Marking
- The CE marking must be affixed by the manufacturer or its authorized representative.
- It should be displayed visibly, legibly, and permanently on the product.
- The letters "CE" should maintain the same vertical dimension, not less than 5 mm.
- If the product cannot accommodate the CE mark, it should be placed on packaging or related documentation.
Note: CE marking is essential for manufacturers aiming to sell products in the European market. Understanding the requirements and processes involved is crucial for compliance. By adhering to these guidelines, manufacturers can ensure their products meet the necessary safety and health standards, thus facilitating smoother access to the EU marketplace.
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