CE CERTIFICATION

What is the CE mark?

The CE mark is an essential symbol affixed by manufacturers to products intended for sale in Europe. It is mandatory for products falling under one of 24 European directives. The CE mark signifies that the manufacturer assumes responsibility for ensuring the product complies with all relevant European standards for health, safety, performance, and environmental requirements. CE stands for "Conformité Européenne," indicating conformity with European regulations.

The CE mark is mandatory across all 27 EU member states, as well as in Iceland, Norway, and Liechtenstein. Switzerland recognizes the CE mark for certain products, and Türkiye mandates CE marking for many products sold within its borders.

Definition of manufacturer:

The individual or entity responsible for designing, manufacturing, packaging, and labeling a device prior to its introduction into the market under their own brand name.

In essence, CE marking grants access to a market comprising more than 500 million consumers.

The responsibility for affixing the CE mark lies with the manufacturer, whether based within or outside the EU. Manufacturers outside the EU can designate an authorized representative within the EU to act on their behalf. CE marking entails more than just attaching a symbol to a product; it involves ensuring compliance and accountability throughout the process.

These six steps integrate expert insights on CE marking and valuable EU resources, gathered from experts and Trade Commissioners.

Step 1: Identify the CE directive(s) applicable to your product.

To determine if your product requires a CE mark, start by checking if it falls under any of the 24 CE directives listed below. If it does, CE marking is mandatory for your product.

What is directive?

A directive within the European Union is a legislative measure that mandates member states to align their national laws to achieve specific outcomes consistent with EU regulations in that domain.

As an example, the EU directive concerning products categorized under electromagnetic compatibility requires member states to ensure that electrical devices meeting this classification adhere to specific regulatory standards.

The EMC directive initially restricts electromagnetic emissions from equipment to prevent interference with radio, telecommunication, and other devices when used as intended. Additionally, it regulates the immunity of equipment to interference, ensuring it remains unaffected by radio emissions during proper use.
-European Commision

Be Prepared

Identifying whether your product falls under one or more directives can pose challenges. For instance, if you produce electronic packaging machines equipped with a conveyor belt, multiple directives will affect your compliance requirements. To determine applicable directives, thorough examination of each of the 24 directives (sometimes detailed in annexes) is necessary. Currently, no centralized tool or database lists directives applicable to specific products. Consulting a trade commissioner can provide guidance through these complexities.

After determining whether your product falls under one or more directives, the next step is to evaluate its compliance with the relevant directive(s). If your product does not conform, you need to strategize how to achieve compliance.

Step 2: Understand the essential requirements applicable to your product.

Each directive specifies the legal requirements set by the EU for your product to achieve compliance, formally known as "essential requirements" within the directive. These requirements are broadly defined. However, the directives do not provide specific guidance on designing a product to meet these essential requirements.

Harmonized standards

The European Commission frequently mandates European organizations such as CEN, CENELEC, and ETSI to develop standards that align with the essential requirements outlined in the directives.

A product that meets harmonized standards is considered to comply with the essential requirements specified in applicable directives.

Other standards

In numerous instances, manufacturers may use standards other than harmonized standards to show compliance with the essential requirements outlined in the directives. However, there are specific regulations like the Construction Products Regulation where the use of harmonized standards is obligatory.

European Commission guidelines

The European Commission frequently offers comprehensive guidelines regarding the implementation of specific directives, including interpretations of their essential requirements. These guidelines, although lacking legal standing (as only the official directive text holds legal weight), are typically developed in consultation with Member State authorities responsible for directive enforcement.

Harmonized standards for construction products

• Column 1:ESO, also known as the European Standards Organization, oversees the adoption and publication of EU standards. In the case of the construction products listed above, the European Committee for Standardization (CEN) is the authoritative body responsible for these standards.

• Column 2:Refers to the title of the harmonized standard and its associated reference document.

• Column 3: The reference to the previously maintained standard, where applicable.

• Column 4: The date when the standard became effective.

• Column 5:The date marking the end of the period during which the old standard can be used.

Once you have identified the essential requirements outlined in the directives and harmonized standards relevant to your product, you must ascertain if your product meets these requirements. Determine if it's necessary to engage a conformity assessment body for testing and certification to ensure compliance.

Step 3: Determine if you need third-party certification

Certain directives mandate that products undergo testing and certification by a third-party organization to verify compliance with essential requirements. These organizations, globally recognized as conformity assessment bodies, are referred to as notified bodies (NB) within Europe. In cases where directives do not stipulate NB involvement, manufacturers may utilize their internal facilities to assess product conformity.

A notified body is an organization authorized by European authorities to evaluate whether a product meets the essential requirements specified in the applicable directives. NBs also conduct audits to ensure that manufacturers have completed steps 1 and 2, which involve identifying the directives and essential requirements applicable to their products.

Certain directives specify that manufacturers must engage a notified body (NB) for certain products.

• the Medical Devices directive

• the Equipment and Protective Systems in Potentially Explosive Atmospheres directive

• the Pressure Equipment directive

• the Appliances Burning Gaseous Fuels directive

• the Simple Pressure Vessels directive

Some directives do not mandate manufacturers to depend on notified bodies (NBs) if they utilize a harmonized standard (refer to step 2) to ensure conformity with essential requirements. However, for certain products under these directives such as the Machinery directive and the Toy Safety directive, the involvement of an NB is compulsory if manufacturers do not utilize the relevant harmonized standard.

The EU has minimized the range of products necessitating NB assessment. For instance, the Low Voltage directive does not mandate NB involvement. European authorities are progressively emphasizing that manufacturers demonstrate their products' compliance.

Step 4: Assess product conformity

To ensure compliance with essential requirements outlined in relevant directives, it's crucial to conduct thorough testing and comprehensive documentation to confirm conformity. Each directive specifies specific conformity assessment modules that manufacturers can utilize based on their product category. These modules range from self-certification to involvement of notified bodies, depending on the product's risk profile. By following these directives and selecting the appropriate assessment module, manufacturers can demonstrate compliance effectively and obtain necessary certifications like CE marking for market access in the European Economic Area (EEA).

• Module AInternal production control

• Module BEC type examination

• Module CConformity to type

• Module DProduction quality assurance

• Module EProduct quality assurance

• Module FProduct verification

• Module GUnit verification

• Module HFull quality assurance (EN ISO 9001)

Taking Module B as an example, the following chart provides a clear breakdown of responsibilities between manufacturers and notified bodies, along with tasks that manufacturers can delegate to authorized representatives. As products move towards Module H, the role of a notified body becomes increasingly critical in the conformity assessment process. This structured approach ensures compliance with regulatory requirements and facilitates market access within the European Economic Area (EEA).

Module: B

• The manufacturer is responsible for creating technical documentation that covers the design, manufacturing process, and operational details of the product.

• The manufacturer or their authorized representative performs the following tasks:

  • Applies for the EC type examination.

  • Provides one or more specimens to the notified body, which represent the intended production.

  • Notifies the notified body of any modifications made to the approved product.

  • Maintains the technical documentation, including a copy of the EC type examination certificate, accessible for surveillance authorities.

• Notified body:

  • Confirms through examinations and tests, whether conducted directly or by others, that the specimen(s) comply with relevant regulations and aligns with the technical documentation.

  • Issues an EC type examination certificate upon successful assessment.

  • Retains copies of the certificate and maintains records of pertinent technical details.

  • Shares relevant information about EC type examination certificates with other notified bodies as necessary.

These 8 procedures can be boiled down to two approaches:

1. Assessment of conformity by the manufacturer:

Manufacturers have the option to engage service providers for access to testing facilities, paying specifically for testing or other aspects of conformity assessment, excluding consulting and certification services typically provided by notified bodies (NBs). Companies equipped with their own testing facilities can independently assess product conformity, offering a more cost-effective approach compared to engaging NBs for these services.

2. Assessment of conformity by an NB:

While manufacturers must engage a notified body (NB) to assess conformity and certify their products, they retain ultimate responsibility for ensuring compliance with EU essential requirements.
Conducting conformity assessment according to European directives for CE marking involves various activities such as product testing, visual inspection, risk analysis, and evaluation of product labels and instructions.

Typical steps which may be involved in the assessment of conformity include:

• Examination of the technical documentation pertaining to the product's design, manufacture, and operational aspects.

• Testing of individual product aspects, samples, or representative specimens.

• Evaluation of the manufacturer's production quality systems.

• Continuous monitoring to verify product conformity at the unit level.

Step 5: Create and maintain technical documentation

Every CE marking directive mandates that manufacturers create and maintain technical documentation, also known as a technical file. This documentation must contain comprehensive information proving the product's conformity to the directive's requirements.

Technical documentation required for a CE-marked product must be retained for a minimum of 10 years from the last manufacturing date, unless specified otherwise by the directive. It must be readily available for enforcement authorities upon request, often within tight deadlines. It is essential to keep this documentation current, particularly when the product undergoes modifications or updates in conformity assessment procedures.

Translation

While various CE marking directives and European national laws require user information, such as manuals, to be translated into official languages of the countries where products are sold, other technical documentation can be maintained in any EU language, including English or French.

Location of the technical documentation

According to EU regulations, it is not mandatory for technical documentation to be physically located within Europe. However, there are specific requirements for the Declaration of Conformity (refer to step 6). Importers in the EU must ensure that exporters provide this documentation to EU enforcement authorities. Furthermore, EU importers or distributors who sell products under their own brands must have access to a comprehensive copy of the technical documentation.

Examples

Technical Document Required for the Low Voltage Directive

• Information on the design, manufacturing process, and operation of the electrical equipment necessary to assess its conformity with directive requirements.

• An overview of the electrical equipment's general characteristics.

• Drawings and diagrams detailing the design and assembly of components, subassemblies, circuits, etc.

• Descriptions and explanations to aid in interpreting the aforementioned drawings, diagrams, and operational aspects of the electrical equipment.

• A compilation of standards utilized, either fully or partially, along with descriptions of the approaches taken to ensure safety compliance when harmonized standards were not applied.

• Findings from design calculations and verification checks conducted.

• Testing reports, whether conducted by the manufacturer or a third party.

Technical Document Required for the Electromagnetic Compatibility Directive (EMCD)

• Clear identification of the product covered by the technical documentation, ensuring a direct link between the document and the product.

• A comprehensive description of the apparatus, tailored to its complexity. Simple apparatus may require only a brief description, while more intricate devices may necessitate a detailed explanation or visual representation.

• Evidence of compliance if European harmonized standards have been applied, including a dated list of these standards and the corresponding test results.

• Description of steps taken to meet essential requirements if European harmonized standards were not fully applied, including an EMC Assessment as outlined in Annex II of the directive. This section should encompass test reports, design calculations, and examinations conducted.

• In cases where Annex III of the EMCD procedure is utilized by the manufacturer, inclusion of the notified body statement is mandatory.

Step 6: Declaration of conformity & affixing the CE mark

The Declaration of Conformity serves as the document certifying compliance with CE marking directives. It represents the manufacturer's acknowledgment of their responsibility for ensuring their products conform to the applicable directives.

The Declaration of Conformity is the exclusive responsibility of the manufacturer and is legally required to be established.

The Declaration of Conformity must be accessible to authorities at EU entry points. Unlike the complete technical documentation, which may not always need to be shared with importers and distributors (see step 5), the Declaration of Conformity should be provided to EU distributors. They may be required to furnish it promptly to national authorities upon request.

Typically, the Declaration of Conformity is a concise document that includes the following information:

• who you are,

• what product it refers to,

• what directives are involved,

• which standards have been used,

• where test results can be found,

• who is responsible in your company.

Note: The Declaration of Conformity necessary for your product may vary from the example provided below. Refer to your directive for specific guidance.

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