CE marking according to various directives – guide is a complex process demanding significant effort from manufacturers and other economic operators. The CE mark confirms that a product meets all relevant EU regulations concerning health, safety, and environmental protection. Below, we outline the detailed process of CE marking according to different directives, focusing on the Machinery Directive, Low Voltage Directive, Pressure Equipment Directive, and Electromagnetic Compatibility Directive.
Table of Contents
CE Marking: Machinery Directive (2006/42/EC)
1. Identifying Relevant Requirements
The first step in the CE marking process involves identifying the relevant requirements of the Machinery Directive applicable to the product. Manufacturers must determine which regulations apply to their machine and what standards must be met. This requires a thorough analysis of the machine’s technical specifications and its intended use.
2. Risk Assessment
Risk assessment is a crucial element in the CE marking process. Manufacturers are obligated to conduct a risk analysis to identify all potential hazards associated with the machine’s use. This analysis should cover:
- Identification of potential hazards
- Risk assessment at all stages of the machine’s lifecycle (installation, operation, maintenance)
- Preventive and control measures to minimize risk
3. Conformity Assessment
Manufacturers have two main options for conformity assessment depending on the machine type:
- Self-Conducted Conformity Assessment: For less risky machines, manufacturers can independently conduct the conformity assessment and compile technical documentation confirming compliance with the directive.
- EC Type Examination: For more complex and risky machines, an EC type examination by a notified body may be necessary. The notified body evaluates the machine design and its compliance with relevant requirements.
4. Technical Documentation
Preparing technical documentation is a key step in the CE marking process. This documentation must include all necessary information regarding the machine’s design, production, and use, including:
- Technical drawings and schematics
- Descriptions of production processes
- Test and examination reports
- Risk analysis
- Description of preventive and control measures
5. EC Declaration of Conformity
The manufacturer must draft and sign an EC Declaration of Conformity, declaring that the machine meets all relevant requirements of the Machinery Directive. This declaration must be retained for at least 10 years from the date the machine is placed on the market. The EC Declaration of Conformity should include:
- Name and address of the manufacturer
- Description of the machine
- References to applicable directives and harmonized standards
- Signature of the responsible person
6. Affixing the CE Mark
Once all requirements are met, the manufacturer can affix the CE mark to the machine. The CE mark must be placed visibly, legibly, and indelibly. Additionally, the manufacturer should ensure that:
- The CE mark is placed on the machine’s nameplate
- All accompanying documents include the appropriate marking
CE Marking: Pressure Equipment Directive (2014/68/EU)
The Pressure Equipment Directive (PED) regulates the design, manufacture, and conformity of pressure equipment introduced to the EU market. CE marking according to the PED involves:
1. Identifying Requirements
Manufacturers must determine whether their product falls within the scope of the PED. This directive covers pressure equipment such as vessels, piping, safety accessories, and pressure assemblies.
2. Conformity Assessment
Manufacturers have several options for conformity assessment, depending on the pressure equipment category:
- Module A (Internal Production Control): For low-risk equipment.
- Modules A2, B, C, D, E, H: For higher-risk equipment, a notified body may need to conduct the conformity assessment.
3. Technical Documentation
Technical documentation must include detailed information about the design, production, and testing of the pressure equipment. The documentation should cover:
- Technical drawings
- Design calculations
- Test reports
- Risk analysis
4. EU Declaration of Conformity
The manufacturer must sign an EU Declaration of Conformity, confirming that the pressure equipment meets the PED requirements. The declaration should include:
- Name and address of the manufacturer
- Description of the pressure equipment
- References to applicable directives and harmonized standards
- Signature of the responsible person
5. Affixing the CE Mark
The pressure equipment must bear the CE mark, affixed in a durable and legible manner. The manufacturer should ensure that:
- The CE mark is placed on the equipment’s nameplate
- All accompanying documents include the appropriate marking
CE Marking: Electromagnetic Compatibility Directive (2014/30/EU)
The Electromagnetic Compatibility (EMC) Directive aims to ensure that electrical and electronic devices do not cause electromagnetic interference and are immune to such interference. CE marking according to the EMC Directive involves the following steps:
1. Identifying Requirements
Manufacturers must determine which EMC Directive requirements apply to their product. The directive covers electrical and electronic devices that can cause or be affected by electromagnetic interference.
2. Conformity Assessment
Manufacturers can conduct conformity assessment in two ways:
- Internal Conformity Assessment: For low-risk devices, manufacturers can independently conduct conformity assessment through appropriate internal tests.
- Assessment by a Notified Body: For more complex devices, manufacturers may use a notified body to conduct electromagnetic compatibility tests.
3. Technical Documentation
Technical documentation must include electromagnetic compatibility test results and details about the device’s design and production. The documentation should cover:
- Technical descriptions
- Test reports
- Risk analysis
4. EU Declaration of Conformity
The manufacturer must sign an EU Declaration of Conformity, confirming that the device meets the EMC Directive requirements. The declaration should include:
- Name and address of the manufacturer
- Description of the device
- References to applicable directives and harmonized standards
- Signature of the responsible person
5. Affixing the CE Mark
Devices meeting the EMC Directive requirements must bear the CE mark, affixed in a durable and legible manner. The manufacturer should ensure that:
- The CE mark is placed on the device in a visible location
- All accompanying documents include the appropriate marking
CE Marking: Low Voltage Directive (2014/35/EU)
The Low Voltage Directive applies to electrical equipment operating within specific voltage ranges. CE marking according to this directive involves the following steps:
1. Identifying Requirements
Manufacturers must determine whether their product falls within the scope of the Low Voltage Directive. This directive covers electrical equipment operating at voltages between 50V and 1000V AC or 75V and 1500V DC.
2. Conformity Assessment
Manufacturers have two paths for conformity assessment:
- Internal Production Control: Manufacturers can independently conduct conformity assessment if the electrical equipment is simple and low-risk.
- Involvement of a Notified Body: For more complex electrical equipment, manufacturers may use a notified body for testing and conformity assessment.
3. Technical Documentation
Technical documentation should include detailed information about the equipment’s design, production, and testing. The documentation must cover:
- Technical drawings
- Electrical schematics
- Test reports
- Risk analysis
4. EU Declaration of Conformity
The manufacturer must sign an EU Declaration of Conformity, confirming that the electrical equipment meets the Low Voltage Directive requirements. The declaration should include:
- Name and address of the manufacturer
- Description of the equipment
- References to applicable directives and harmonized standards
- Signature of the responsible person
5. Affixing the CE Mark
Electrical equipment must bear the CE mark, affixed in a durable and legible manner. The manufacturer should ensure that:
- The CE mark is placed on the equipment’s nameplate
- All accompanying documents include the appropriate marking
The process of CE marking is demanding and consists of several key stages that must be meticulously followed. It requires significant effort in both risk assessment and technical documentation. However, the CE mark is essential for ensuring product compliance with European safety standards and enabling their introduction to the EU market.
Manufacturers must identify the relevant requirements for their product, conduct risk and conformity assessments, prepare technical documentation, draft the EU Declaration of Conformity (or EC for machinery), and then affix the CE mark to the product. Depending on the product type and associated risks, manufacturers may independently conduct conformity assessment or use a notified body. Each directive has its specific requirements that must be met for a product to be legally introduced to the European Union market.
FAQ: CE Marking Process
The CE mark is a symbol indicating that a product meets all applicable safety, health, and environmental protection requirements set out in EU regulations. The CE mark allows for the free movement of goods within the European Economic Area (EEA).
The CE mark is required for many products, including machinery, electrical equipment, pressure equipment, radio equipment, construction products, medical devices, and toys. These requirements are specified in the relevant EU directives.
The main steps include: identifying the relevant directive requirements, conducting risk assessment, performing conformity assessment, preparing technical documentation, drafting the EU Declaration of Conformity (or EC for machinery), and affixing the CE mark to the product.
No, a notified body is not always required. For less risky products, manufacturers can independently conduct conformity assessment. However, for more complex or risky products, involving a notified body may be necessary.
The EU Declaration of Conformity is a document in which the manufacturer declares that their product meets all relevant EU directive requirements. The declaration must be signed by the manufacturer and retained for a specified period.
The EU Declaration of Conformity is used in most EU directives, while the EC Declaration of Conformity is specific to the Machinery Directive. Both documents serve a similar function but may differ in specific requirements.
Technical documentation must include detailed information regarding the product’s design, production, and testing. It should cover technical drawings, schematics, test reports, risk analysis, and descriptions of preventive and control measures.
Manufacturers must retain technical documentation for at least 10 years from the date the last product unit is placed on the market.
If a product does not meet EU directive requirements, it cannot be CE marked or placed on the EU market. Introducing such a product may result in penalties, product recalls, and other legal consequences.
The CE mark is required and recognized in the European Union and the European Economic Area (EEA). Outside this area, compliance requirements may differ, so manufacturers must check local regulations in countries where they export their products.