CE marking under various directives

Affixing the CE marking is a complex process that requires considerable effort from both manufacturers and other economic operators. The CE marking confirms that a product complies with all applicable requirements laid down in EU legislation on health, safety, and environmental protection. Below, we outline the detailed process for affixing the CE marking under various directives, with particular emphasis on the Machinery Directive, the Low Voltage Directive, the Pressure Equipment Directive, and the Electromagnetic Compatibility Directive.

Affixing the CE Marking: Machinery Directive (2006/42/EC)

1. Identifying the applicable requirements

The first step in the CE marking process is to identify the relevant requirements of the Machinery Directive that apply to the product in question. The manufacturer must determine which regulations apply to the machine and which standards must be met. This requires a thorough analysis of the machine’s technical specification, intended use, and the broader framework described in the Machinery Directive and the new Machinery Regulation.

2. Risk assessment

Risk assessment is a key part of the CE marking process. The manufacturer is required to carry out a risk analysis to identify all possible hazards associated with the use of the machine. This analysis should cover:

• Identification of potential hazards
• Risk assessment at all stages of the machine’s use (installation, operation, maintenance)
• Preventive and control measures aimed at minimizing risk

3. Conformity assessment

The manufacturer has two main conformity assessment options, depending on the type of machine:

1. Conformity assessment carried out by the manufacturer: For lower-risk machines, the manufacturer may carry out the conformity assessment independently and prepare the technical documentation confirming compliance with the requirements for CE marking of machinery.
2. EC type-examination: For more complex and higher-risk machines, an EC type-examination by a notified body may be required. The notified body assesses the machine design and its compliance with the relevant requirements.

4. Technical documentation

Preparing the technical documentation is a key stage in the CE marking process. This documentation must include all necessary information on the design, manufacture, and use of the machine, including:

• Technical drawings and diagrams
• Descriptions of manufacturing processes
• Test and examination reports
• Risk analysis
• Description of preventive and control measures

5. EC Declaration of Conformity

The manufacturer must draw up and sign the EC Declaration of Conformity, stating 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 the applicable directives and harmonized standards
• Signature of the responsible person

6. Affixing the CE marking

Once all requirements have been met, the manufacturer may affix the CE marking to the machine. The CE marking must be visible, legible, and durable. In addition, the manufacturer should ensure that:

• The CE marking is placed on the machine’s nameplate
• All documents accompanying the machine contain the appropriate marking

Affixing the CE Marking: Pressure Equipment Directive (2014/68/EU)

The Pressure Equipment Directive (PED) regulates the design, manufacture, and conformity of pressure equipment placed on the EU market. Affixing the CE marking under the PED includes:

1. Identifying the requirements

The manufacturer must determine whether the 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

The manufacturer has several conformity assessment options, depending on the category of the pressure equipment:

1. Module A (internal production control): For low-risk equipment.
2. Modules A2, B, C, D, E, H: For higher-risk equipment, the involvement of a notified body in the conformity assessment may be required.

3. Technical documentation

The technical documentation must include detailed information on the design, manufacture, and testing of the pressure equipment. The documentation should include:

• 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 requirements of the PED. The declaration should include:

• The manufacturer’s name and address
• A description of the pressure equipment
• References to the applicable directives and harmonised standards
• The signature of the responsible person

5. Affixing the CE marking

The pressure equipment must bear the CE marking, affixed in a permanent and legible manner. The manufacturer should ensure that:

• The CE marking is placed on the equipment nameplate
• All documents accompanying the equipment contain the appropriate marking

Affixing the CE marking: EMC Directive (2014/30/EU)

The Electromagnetic Compatibility (EMC) Directive is intended to ensure that electrical and electronic equipment does not generate electromagnetic disturbance and is sufficiently immune to such disturbance. Affixing the CE marking under the EMC Directive involves the following steps:

1. Identifying the requirements

The manufacturer must determine which EMC Directive requirements apply to the product. The EMC Directive covers electrical and electronic equipment that may generate electromagnetic disturbance or be affected by it, as outlined in the EMC Directive requirements for engineers.

2. Conformity assessment

The manufacturer may carry out the conformity assessment in two ways:

1. Internal conformity assessment: For low-risk equipment, the manufacturer may carry out the conformity assessment independently by performing the relevant in-house tests.
2. Assessment by a notified body: For more complex equipment, the manufacturer may use the services of a notified body to carry out electromagnetic compatibility testing.

3. Technical documentation

Technical documentation must include the results of electromagnetic compatibility testing, as well as details of the design and manufacture of the equipment. The documentation should include:

• Technical descriptions
• Test reports
• Risk analysis

4. EU Declaration of Conformity

The manufacturer must sign an EU Declaration of Conformity confirming that the equipment meets the requirements of the EMC Directive. The declaration should include:

• The manufacturer’s name and address
• A description of the equipment
• References to the applicable directives and harmonised standards
• The signature of the responsible person

5. Affixing the CE marking

The CE marking must be affixed to equipment that meets the requirements of the EMC Directive in a permanent and legible manner. The manufacturer should ensure that:

• The CE marking is placed visibly on the equipment
• All documents accompanying the equipment contain the appropriate marking

Affixing the CE marking: Low Voltage Directive (2014/35/EU)

The Low Voltage Directive applies to electrical equipment operating within a specified voltage range. Affixing the CE marking under this directive involves the following steps:

1. Identifying the requirements

The manufacturer must determine whether the product falls within the scope of the Low Voltage Directive. This directive covers electrical equipment operating at voltages from 50V to 1000V AC and from 75V to 1500V DC.

2. Conformity assessment

The manufacturer has two conformity assessment routes to choose from:

1. Internal production control: The manufacturer may carry out the conformity assessment independently if the electrical equipment is simple and does not involve significant risk.
2. Involvement of a notified body: For more complex electrical equipment, the manufacturer may use the services of a notified body to carry out testing and conformity assessment.

3. Technical documentation

The technical documentation should include detailed information on the design, manufacture, and testing of the equipment. The documentation must include:

• Technical drawings
• Electrical diagrams
• 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 requirements of the Low Voltage Directive. The declaration should include:

• The manufacturer’s name and address
• A description of the equipment
• References to the applicable directives and harmonised standards
• The signature of the responsible person

5. Affixing the CE marking

Electrical equipment must bear the CE marking, affixed in a permanent and legible manner. The manufacturer should ensure that:

• The CE marking is placed on the equipment nameplate
• All documents accompanying the equipment include the appropriate marking

Affixing the CE marking is a demanding process made up of several key stages that must be followed carefully. It requires substantial effort, both in terms of risk assessment and technical documentation. However, the CE marking is essential to ensure products comply with European safety standards and can be placed on the EU market.

The manufacturer must identify the requirements applicable to the product, carry out a conformity and risk assessment, prepare the technical documentation, draw up the EU Declaration of Conformity (or EC Declaration of Conformity in the case of machinery), and then affix the CE marking to the product. Depending on the type of product and the risks associated with it, the manufacturer may carry out the conformity assessment independently or use the services of a notified body. Each directive has its own specific requirements that must be met for the product to be lawfully placed on the European Union market. For machinery, see industrial automation, design office support, adapting machines to minimum requirements, and CE certification of machinery.