CE Certification

CE Marking is a certification mark that is required for products sold within the European Economic Area (EEA). CE stands for "Conformité Européenne," which translates to European Conformity. This mark indicates that the product complies with stringent safety, health, and environmental protection standards. However, not every product needs CE marking; only those for which EU standards have been set require it. The EU has established requirements for over 20 product sectors under the "New Approach" Directives (also known as regulations), including but not limited to:

• Gas Appliances Regulation (GAR)
• Construction Products Regulation (CPR)
• Low Voltage Directive (LVD)
• Pressure Equipment Directive (PED)
• Electromagnetic Compatibility Directive (EMC)
• Equipment for potentially explosive atmospheres (ATEXS)

Countries that require CE marking

Table 1 has a comprehensive list of countries that require CE marking on products. These countries are either in the EEA or EFTA (European Free Trade Association). Although a country is not on this list, it may still accept CE marking on products like Turkey.

Note: For the United Kingdom, please see our UKCA page. In addition, see the United Kingdom's guidance on CE marking.

Table 1: Countries that require CE marking

Austria	Finland	Latvia	Portugal
Belgium	France	Liechtenstein	Romania
Bulgaria	Germany	Lithuania	Slovakia
Croatia	Greece	Luxembourg	Slovenia
Cyprus	Hungary	Malta	Spain
Czech Republic	Iceland	The Netherlands	Sweden
Denmark	Ireland	Norway
Estonia	Italy	Poland

Products that typically have CE certification

• Electrical equipment: This includes household appliances, lighting equipment, cables, and power supply units. Products within certain voltage limits fall under the Low Voltage Directive and require CE marking.
• Electronic devices: Including radio and telecommunications equipment, information technology equipment, and consumer electronics. These must comply with the Electromagnetic Compatibility Directive and, in some cases, the Radio Equipment Directive.
• Medical devices: Ranging from simple bandages to advanced imaging equipment. Depending on their classification, medical devices must adhere to the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR).
• Personal protective equipment (PPE): Helmets, gloves, safety goggles, protective clothing, and respiratory protective devices. These products must meet the requirements of the PPE Regulation.
• Machinery: Including a wide range of machinery, interchangeable equipment, and safety components. The Machinery Directive outlines the health and safety requirements for machinery.
• Toys: All toys intended for play by children under 14 must comply with the Toy Safety Directive.
• Construction products: Materials and products used in building and construction, including windows, doors, and structural components, must meet the criteria in the Construction Products Regulation.
• Pressure equipment: Such as pressure vessels, piping, safety valves, and pressure accessories. These products may fall under the Pressure Equipment Directive or the Simple Pressure Vessels Directive, depending on the pressure and volume.
• Gas appliances: Products that burn gaseous fuels for heating, cooking, or refrigeration must comply with the Gas Appliances Regulation.
• Measuring instruments: Including utility meters (water, gas, electricity), taxi meters, and measuring devices used in commercial transactions. These must adhere to the Measuring Instruments Directive.
• Lifts and elevators: Components and safety devices for lifts must meet the requirements of the Lifts Directive.
• Recreational craft: Boats and watercraft intended for sport or leisure, ranging from 2.5 to 24 meters long, must comply with the Recreational Craft Directive.
• Explosives for civil uses: Products like fireworks and other pyrotechnic devices fall under the Pyrotechnic Articles Directive.
• Hot water boilers: Boilers for heating water powered by liquid or gaseous fuels must meet the efficiency requirements of the Hot Water Boilers Directive.

How to get CE certification

Obtaining CE certification is a critical step for manufacturers and producers aiming to enter or expand their presence in the European market. Here's a structured approach to achieving CE certification for a product:

1. Identify relevant directives and standards: The first step is determining which EU directives and harmonized standards apply to the product. These vary depending on the product's nature, usage, and the risks it may pose.
2. Conduct a risk assessment: Evaluate the product to identify potential health, safety, or environmental risks. This assessment forms the basis of the conformity process.
3. Self-assessment or third-party testing: Depending on the product category, it may be possible to self-certify the product by ensuring it meets the relevant EU requirements. More complex or higher-risk products may require assessment and testing by a Notified Body, an organization designated by an EU country to assess the conformity of certain products before being placed on the market.
4. Prepare technical documentation: This documentation should detail the product's design, manufacture, and operation and demonstrate how the product meets the relevant EU requirements. The documentation typically includes a risk assessment, design drawings, schematics, manufacturing processes, and, if applicable, test reports.
5. Draft a Declaration of Conformity (DoC): The DoC is a document prepared by the manufacturer that declares that the product meets all the necessary EU requirements. The DoC must include product identification, the directives and standards it complies with, the manufacturer's details, and information about the Notified Body if involved in the assessment process.
6. Place the CE mark on the product: Once compliance with all relevant directives and standards and all necessary documentation is compiled, affix the CE mark to the product. The CE mark must be visible, legible, and indelible. The size of the mark must also be in proportion to the size of the product, though minimum dimensions are specified.
7. Ensure ongoing compliance: Compliance with CE marking is not just about the initial certification; it's about maintaining standards throughout the product's production lifecycle after it is CE certified. Regularly review and update the risk assessments, technical documentation, and compliance with any changes in EU legislation.
8. Keep records: Maintain records of the technical documentation, Declaration of Conformity, and any correspondence or reports from Notified Bodies for ten years after the product has been placed on the market. These documents must be made available to national authorities upon request.

FAQs

What does the CE mark mean?

CE stands for Conformité Européenne, which indicates that a product meets the safety, health, and environmental standards established for the European Economic Area.

Who issues the CE certificate?

The CE certificate can be self-certified for many general products. Products used in extreme applications may need certification by notified bodies.