CE marking is a conformity mark that the manufacturer (see definition below) places on products to sell them in Europe. This marking is mandatory for products that fall under one of the European directives (see table "Mandatory CE certification applies to the following product groups"). The CE marking indicates that the manufacturer assumes responsibility for complying with all European Union (EU) health, safety, efficiency and environmental protection requirements that apply to his products. CE stands for "conformité européenne" (French: "European conformity"). This marking is mandatory in the 27 EU member states, as well as in Iceland, Norway and Liechtenstein. Switzerland uses the CE marking for some products, and even Turkey requires the marking to appear on a large list of products.

Definition of manufacturer - The individual or entity responsible for designing, packaging, and labeling of a product for the purpose of placing it on the market in its own name.

Most important fact is that the CE marking provides access to the EU market of more than 500 million consumers.

The CE marking is not analogous to other conformity marks. For example, the EAC (Eurasian Union) or UL (Underwriters Laboratories - Safety Standards and Certification) marking cannot be used before determination by the independent certification bodies that the product meets the required standards.

The right to use the CE marking is not granted by any European authority, as it does not fall under the competence of any organization. Only the manufacturer himself, whether he is in the EU or outside the EU, is ultimately responsible for the application and proper use of the CE marking. In addition, a manufacturer located outside the EU may allow an authorized representative from the EU to act on his behalf.

CE certification is not just about putting a symbol on a product.

The six basic steps of CE marking

Stage 1: Identify one or more directives that apply to your products

How to get information if your products should be CE marked? The first step is to check that your products fall under one or more of the EU directives listed below. If your products fall under one or more of these directives, you must affix the CE marking.

For more information, you can visit the European Commission's website at www.ec.europa.eu (in English)

Mandatory CE certification applies to the following product groups:

Number of the directive

Product categories

2014/35/EU

Equipment with certain voltage limits

2014/29/EU

Simple pressure vessels

2009/125/EC

Ecodesign requirements for energy-related products

2000/14/EC

Noise emission in the environment by equipment for use outdoors

2009/48/EC

Safety of toys

(EU) 305/2011

Construction products

2014/30/EU

Electromagnetic compatibility

2006/42/EC

Machinery

(EU) 2016/425

Personal protective equipment

2014/31/EU

Non-automatic weighing instruments

(EU) 2016/426

Appliances burning gaseous fuels

92/42/EEC

Hot-water boilers fired with liquid or gaseous fuels

2014/28/EU

Explosives for civil uses

(EU) 2017/745

Medical devices

(EC) 1907/2006

Chemicals (REACH)

98/79/EC

In-vitro diagnostic medical devices

2014/34/EU

Equipment and protective systems intended for use in potentially explosive atmospheres

2013/53/EU

Recreational craft and personal watercraft

2014/33/EU

Lifts and safety components for lifts

2014/68/EU

Pressure equipment

2014/53/EU

Radio equipment

(EU) 2016/424

Cableway installations

2014/32/EU

Measuring instruments

2013/29/EU

Pyrotechnic articles

(EC) 661/2009

Radio interference of vehicles (E-mark)

The general safety of motor vehicles, their trailers and systems, components and separate technical units

What is the EU directive?

A directive is a legal document issued by the European Union that requires member states to adapt their national laws so that the result is data that can be harmonized under EU rules in the field. For example, the EU directive on products in the "Electromagnetic Compatibility" category (Directive 2014/30/EU) requires member states to ensure that electrical equipment in this category meets certain European product requirements: 

“The EMC Directive limits the electromagnetic emissions from the equipment to ensure that, in normal use, the equipment does not interfere with the transmission of radio waves, communications equipment or other equipment. The directive also establishes rules regarding the immunity of the equipment from interference and ensures that the operation of the equipment in normal use will not be impaired by radio emissions.” - European Commission.

Please note the following :

It may be difficult to determine whether your products fall under one or more directives. For example, if you manufacture electronic conveyor belt packaging machines, you will have to deal with more than one directive. In order to determine which one applies to your products, you will need to research each directive (a complete list of products is sometimes posted in an appendix). There is no handbook or database that tells you which directives may apply to which products/equipment. The experts at CCIS-Expertise can help you navigate through this very complex system.

Next step

Once you have determined whether your product falls under one or more directives, you must assess your product's compliance with those directives and, if not, ensure compliance

Stage 2. Determine the basic requirements for products/equipement

Each directive describes in detail what the EU law stipulates for approvement of the compliance of your products/equipment. These are the "basic requirements" of the directive. These requirements are very general. The directives do not describe in detail how to design products to meet the basic requirements.

Harmonized standards

The European Commission often encharges European organizations (CEN, CENELEC and ETSI) to develop standards that are consistent and harmonized with the European product requirements of the directives (in English only). To find out if there is a harmonized standard for your product, visit www.ec.europa.eu, the official website of the European Commission. Any product that complies with the harmonized standard is considered to meet the basic requirements of the applicable directives. For information on the availability and content of harmonized standards, please contact the following organizations:

CEN (European Committee for Standardization)
CENELEC (European Committee for Electrotechnical Standardization)
ETSI (European Telecommunications Standards Institute)

Other standands

In many cases, manufacturers can rely on norms other than the harmonized norms to prove that their products meet the basic requirements of the directives. However, there is one exception to this rule: the Construction Products Regulation (which is soon to replace the Construction Products Directive), which makes the use of harmonized norms mandatory. 

Recommendations of the European Commission

The European Commission provides detailed recommendations on the application of certain directives, including detailed information on the interpretation of the basic requirements of a directive. These recommendations are not legally binding (only the official text of the directive is binding), but they are often drafted in consultation with the state authorities of the member states applying the directives.

Please note the following:

A harmonized standard can cost anywhere from 300 to 1,500 euros. They are expensive documents, but they are a worthwhile investment. Manufacturers do not have to buy these documents to meet the basic requirements of the directive, but European authorities often use them to determine if a product meets the basic requirements. By working with the same documents, you can avoid any technical disputes about your product's compliance with the essential requirements of the directive. Note again that the basic requirements are often vague, leaving a wide margin for technical interpretation.

Example

Here is part of the table of harmonized norms for construction products. It should be noted, however, that not all tables are in the same format.

Harmonized standards for construction products:

Reference and name of the norm (reference to the document)

Reference to the replaced standard

Date of entry into force of the standard as a harmonized European standard

The end date of the coexistence of the old and new standards

EN 1:1998
Flued oil stoves with vaporizing burners

 

01/01/2008 

01/01/2009

EN 1:1998/A1:2007

App. 3

01/01/2008 

01/01/2009

EN 40-4:2005
Lighting columns - Part 4: Requirements for reinforced and prestressed concrete lighting columns

 

01/10/2006 

01/10/2007

EN 40-4:2005/AC:2006

 

01/01/2007 

01/01/2007

Column 1 : ESO, или European organization of standardization, is responsible for the adoption and publication of EU standards. In the case of the above-mentioned building products the author is the European Committee for Standardization (CEN).
Column 2 : Name of the agreed standard and its reference document.
Column 3 : Reference to a previously used standard, if any.
Column 4 : Effective date of the standard.
Column 5 : Date after which the old standard can no longer be used.

Next step

Once you know the basic requirements of the directives and the harmonized standards that apply to your product, you must determine - does your product meet the European product requirements that apply to it? A conformity assessment organization should test your product to certify its compliance.

Stage 3. Do you need third-party CE certification servicies?

Some directives require testing and certification of the products by a third party in order to comply with the basic applicable requirements. These third parties are usually called conformity assessment bodies, but in Europe they are also called certification bodies (CB). If the provisions of the relevant directives do not require the use of CB, manufacturers can carry out conformity assessment at their own facilities. The certification body is the company to which the European authorities grant the right to assess the conformity of products with the basic requirements of the applicable directives. CB also checks whether manufacturers have complied with steps 1 and 2, i.e. whether the principles and basic requirements relating to the product have been defined.

Certain directives oblige the manufacturer to use only CB for product-specific testing and certification. These are the directives for medical devices, equipment for use in potentially explosive atmospheres, pressure equipment, gas equipment and simple pressure vessels. The other directives do not require manufacturers to resort to CB, if they rely on a harmonized standard (see step 2) to determine if their product meets the basic requirements that apply. Nevertheless, these guidelines recommend that the manufacturer contact CB for some products, especially when it is not based on a harmonized standard. This is particularly true of the directives on equipment and toy safety. The EU has reduced the list of products for which the use of CB is mandatory. Thus, the low-voltage directive does not require reference to CB. European authorities impose great responsibility on the manufacturers to ensure that their products are compliant.

Please note the following

To find european product certification bodies authorized by European authorities to carry out conformity assessment, consult NANDO, a database of registered and nominated "new approach" organizations, registered and authorized. Manufacturers can find organizations registered by country and by directive. Most of these organizations are in Europe, but a few have branches or signed contracts with european product certification bodies or testing laboratories in Russia, Canada, USA, etc. However, the experience of interaction with different participants of the process shows that when you apply to companies located directly in the European Union, the speed and quality of services increases significantly. CCIS-Expertise has an office in the heart of Europe (Paris) and maintains the closest relations with European certification bodies and accredited laboratories. Our specialists speak Russian, French, English and German, and our clients are located all over the world, be it in Russia, Ukraine, Kazakhstan, Belarus or Latvia, France and other EU countries, as well as, for example, the USA and Australia. You can learn more about CCIS-Expertise's services on this page : Services in obtaining CE marking. or Request more information and find out the cost of services related to CE certification.

Stage 4: Product Conformity Assessement. Compliance Modules

How do you know that your product meets the basic requirements contained in the directives? You have to check and confirm that the product actually meets them. Each directive describes procedures - so-called "modules" - for assessing compliance, which can be used by the manufacturer. There are eight conformity assessment modules. The relevant directives define the module or modules that belong to the category of the product in question.

Module A : Internal production control;
Module B : CE type expertise;
Module C : Conformity to type;
Module D : Production quality assurance;
Module E : Product quality assurance;
Module F : Product check;
Module G : Piece-by-piece test;
Module H : Total quality control (EN ISO 9001).

Module B :

Manufacturer :

  • develops technical documentation related to the development, production and operation of the product.

Manufacturer or certification body :

  • Requests CE type expertise
  • Makes available to the european product certification body a sample or samples that are representative of planned production
  • Informs the certification body about all changes in the approved product
  • Provides technical documentation, including a copy of the CE-type examination certificate, to the regulatory authorities

Certification Body:

  • Verifies, through examination and testing, that the samples meet the requirements and that they are manufactured in accordance with the technical documentation
  • Issuing a CE-type examination certificate
  • Keeps a copy of the CE certificate and a file of relevant documentation
  • Communicates with other certification bodies regarding CE-type certification information

These eight procedures can be reduced to two approaches:

1. Manufacturer's conformity assessment

A manufacturer can engage a service provider to gain access to testing facilities, but it pays only for testing or other elements of conformity assessment, not consultation or certification, which is what CB is used for. If a company has the necessary facilities, it can do the conformity assessment itself. This method is much cheaper.

2. Assessment of compliance by a certification body (CB)

It is the manufacturer's responsibility to contact CB, who will assess and certify the quality of the products produced, but ultimately the manufacturer remains responsible for complying with the basic requirements of the EU. Regarding CE marking, conformity assessment with European directives can consist of various activities, including product testing, visual inspection, risk analysis, and examination of product labeling and instructions. Typical steps that can be part of a conformity assessment include:

  • Expert review of technical documentation related to the design, production and operation of the product;
  • Testing one or more of the more specific properties of each product or product sample, or a sample of products;
  • Evaluation of systems related to the quality of the manufacturer's products;
  • Continuous verification of unit compliance;

Please note the following 

Some directives allow the manufacturer to choose between different conformity assessment procedures for the same product. Knowing all the options can save you a significant amount of time and money.

Next step

Your product has been tested and meets European Community standards. Now you need to prepare the technical documentation.

CE Certificate and CE Declaration - what is it ?

A manufacturer wishing to enter the European market is required to undergo an evaluation of the conformity of his products with the requirements of the European directives under which his products fall. After undergoing this procedure, the manufacturer himself draws up a document called a CE Declaration. The CE Declaration generally contains the following information :

  • Name and address of the manufacturer or his agent within the EU;
  • Product description;
  • Reference to harmonized norms or other technical standards used.

Where applicable, the CE Declaration is accompanied by a CE Certificate issued by the certification body that monitored the conformity of the products. Note that in order to meet the requirements of the directives relating to medical devices, equipment for use in potentially explosive atmospheres, pressure equipment, gas equipment and simple pressure vessels, the manufacturer must engage the authorized Certification Bodies and obtain CE Certificates. For products such as children's toys and industrial equipment, the relevant directives recommend obtaining CE certificates through accredited certification bodies. For more information on the CE Declaration, see "Step 6: Declaration of Conformity and application of the CE marking". 

Stage 5: Preparation of technical documentation and its updating

All directives concerning the CE marking oblige the manufacturer to develop and provide technical documentation (or a technical set of documents) confirming that the product meets the requirements of the directive.

The technical documentation for products with a CE marking must be kept for at least 10 years from the last date of manufacture of the product, unless the directive specifies a longer period. You must be able to provide the technical documentation on request to the certification body responsible for implementation, often at short notice. The technical documentation must be kept up to date, especially if the product has been modified or has been the subject of a conformity assessment procedure.

Although a number of directives and national European labelling laws require that user information (e.g. user manuals) be translated into the official languages of the countries where the product is sold, the rest of the technical documentation can be kept in any EU language (including English or French).

Location of technical documentation

EU legislation does not require that the technical documentation is stored in Europe. This is not the case for the declaration of conformity (see step 6). Nevertheless, EU importers must ensure that the exporter provides this documentation to the EU authorities responsible for sales. In addition, EU importers and distributors who market products under their own names are required to have a copy of the complete technical documentation.

Examples

Technical documentation required by the Low Voltage Directive:

  • Details of the design, manufacture and operation of electrical equipment, insofar as this is necessary to assess the conformity of this equipment with the directive;
  • General description of the electrical equipment;
  • Design and production drawings, as well as diagrams of components, assemblies, circuits, etc.;
  • Descriptions and explanations necessary to understand these drawings and diagrams and the operation of electrical equipment;
  • List of standards applied in whole or partially and description of the solutions adopted to meet the safety aspects of this directive, if no harmonized standards have been applied;
  • Results of calculations, design, testing, etc.;
  • Test reports (by the manufacturer or a third party).

Technical documents required for the electromagnetic compatibility directive (DCEM) :

  • Identification of the product covered by the technical document. This definition should allow to unambiguously link the technical document and the product.
  • General description of the device. The amount of information needed will depend on the complexity of the device. One device can be completely defined in one line, while a more complex device may require a full description (images can be attached).
  • If you have applied harmonized European standards, proof of compliance is required. At a minimum, this should be a dated list of the harmonized European standards applied and the results obtained.
  • If the European standards have not been applied or have been only partially applied, give a description of the measures taken to meet the basic requirements - these must include an assessment of electromagnetic compatibility as described in annex II of the directive. The documentation shall include test reports, calculations made, checks, etc.
  • If a manufacturer is covered by DCEM Appendix III, he must provide a declaration to CB.

Stage 6. Declaration of Conformity and application of  the CE marking

The document that certifies compliance with the CE marking directives is the Declaration of Conformity. The Declaration of Conformity is the manufacturer's approval of responsibility for the conformity of his products with the applicable directives. This document is the sole responsibility of the manufacturer, and the Declaration of Conformity is a legal obligation. The Declaration must be made available to the authorities when crossing the EU border. In contrast to technical documentation (which does not have to be common to all importers and distributors in some cases - see step 5), the Declaration of Conformity must be available to distributors in the EU, who may be obliged to make it available immediately on request to national authorities.

In general, the Declaration of Conformity is a one-page document that specifies:

  • Manufacturer's information;
  • To which product does the Declaration apply;
  • What directives it concerns;
  • What standards have been met;
  • Where can I find the test results;
  • Responsible person in your company.