The following should be taken into account to ensure a successful (CE marking) certification:
- 1. Determine if the product/equipment falls within the scope of the CE marking.
- 2. Classify which European Directive(s) is applicable for the product or the equipment.
- 3. Evaluate which European harmonised standard(s) is applicable with regard to testing purposes.
- 4. Carry out necessary tests or inspections, based on the applicable standard(s).
- 5. Compile Technical Documentation with regard to the applicable Directives.
- 6. Ensure the necessary information for users is available with the product or the equipment.
- 7. Determine the responsibilities, with regard to the certification, for the different parties concerned (Manufacturer/Importer/Distributor/etc.)
- 8. If required, appoint an Authorised Representative situated in the European Union.
- 9. Drawing up an official Declaration in compliance with the requirements as set out in the applicable Directive(s).
- 10. If applicable, affixing the CE marking in a correct manner.
1) Determine if the product/equipment falls within the scope of the CE-marking.
Equipment’s covered by one or more CE Directive (s) must be provided with a CE marking. The Directives for the following equipment are established:
- 1. Cableway installations designed to carry persons
- 2. Construction equipment
- 3. Electromagnetic compatibility
- 4. Equipment and protective systems in potentially explosive atmospheres
- 5. Explosives for civil uses
- 6. Lifts
- 7. Low voltage equipment
- 8. Machinery safety
- 9. Measuring instruments
- 10. Medical devices: Active implantable
- 11. Medical devices: General
- 12. Medical devices: In vitro diagnostic
- 13. New hot-water boilers fired with liquid or gaseous fluids (efficiency requirements)
- 14. Non-automatic weighing instruments
- 15. Packaging and packaging waste
- 16. Personal protective equipment
- 17. Pressure equipment
- 18. Radio and telecommunications terminal equipment
- 19. Recreational craft
- 20. Simple pressure vessels
- 21. Toys safety
2) Classify which European Directive(s) is applicable for the product or the equipment.
Directives broadly describe the essential requirements that equipment must meet. The manufacturer may indicate themselves as to how they will comply to the essential standards and Directives.
3) Evaluate which European harmonised standard(s) is applicable with regard to testing purposes.
European (harmonized) standards (EN standards) are often used in the process of CE Marking. These standards give the technical requirements that an equipment must meet. The application of harmonized standards, leads to presumption of conformity with the essential requirements of the applicable Directive (s). The CE marking symbolizes conformity to all requirements for the equipment according to the essential requirements out of the Directives. The application of the mark rests with the responsible party. In addition to affixing the CE mark, the responsible party must comply with the EC Declaration of Conformity.
4) Carry out necessary tests or inspections, based on the applicable standard(s).
Product testing strongly depends on the equipment. The intended use of the equipment determines the way of testing. The Directive covers certain (harmonised) standards, which determine how the equipment should be produced / tested to meet the essential requirements of the Directive. If the harmonised standards do not cover all essential requirements, then the presumption of conformity only exists for as far as the standard accords with the essential requirements.
If you produce a series of models, with the same characteristics, one representative model may suffice, unless the Directives or standards state otherwise. If the equipment are not exactly the same, but can be regarded as similar equipment, one can certify based on a selection of models that are representative for the entire series.
The Technical File (TF) comprises relevant information, which must demonstrate that all requirements of the Directive(s) have been satisfied. The Technical File must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. The Technical File is also technical proof for the manufacturer, his authorised representative or the importer that serves as a defence with regard to liability claims. The contents of the Technical File has been established in accordance with the concerning products.
6) Ensure the necessary information for users is available with the product or the equipment.
The Directives directly relate to the user’s safety. The information given to the user plays an essential role in reducing or avoiding safety risks. Drafting and providing the instructions with regards to user manuals is a legal, fundamental safety requirement. The user’s manual must contain all information required for a correct and safe use of the product.
7) Determine the responsibilities, with regard to the certification, for the different parties concerned (Manufacturer/Importer/Distributor/etc.)
The manufacturer is responsible for the CE Marking, but if the manufacturer is not located within the EEA, the authorised representative or, in some cases, the importer can take on this responsibility. It is important that the importer (the person responsible for placing the product on the market) is capable to present the supervisory body with an EC Declaration of Conformity and a Technical File. This importer (person responsible for placing the machinery on the market) is only responsible if the manufacturer is not located within the Community and if he has not appointed an authorised representative in the Community.
The Directives distinguish a number of parties that are responsible or take responsibility with regard to CE Marking:
Responsibilities of the Manufacturer
The manufacturer is any natural or legal person responsible for the design and production of a product with the intention of placing the product on the European market under his own name. The responsibility of manufacturer is passed to anyone, who changes the intended use of a product in such a way, that the essential requirements come into effect, or who radically changes or rebuilds a product (and makes a new product) with the intention of placing it on the Community market.
The Directives do not demand that the manufacturer is located within the Community.
The established responsibilities in the Directives are the same for manufacturers located outside the Community, as well as for manufacturers located in a member state.
Responsibilities of the Authorised representative
The manufacturer can be located inside or outside the Community. In both cases, the manufacturer can appoint an authorised representative to act on his behalf for the execution of certain tasks established in the concerning Directives. A manufacturer located outside the Community is not obliged to have an authorised representative, even if this can have certain advantages.
Responsibilities of the Importer / person responsible for placing products on the market
The importer or responsible party established within the Community, who places a product from a country not situated in European Union has a restricted, but clearly described responsibility under the Directives. In the Directives, the importer or responsible party is referred to as the person responsible for placing products on the market and is therefore responsible.
8) If required, appoint an Authorised Representative situated in the European Union.
An authorised Representative acts on behalf of the manufacturer. The manufacturer can be located inside or outside the Community. In both cases, the manufacturer can appoint an authorised representative to act on his behalf for the execution of certain tasks established in the concerning Directives.
The tasks that can be appointed to the authorised representative, according to the Directives, have an administrative nature. Depending on the conformity assessment procedure and the concerning Directive, the authorised representative can, for example, have the task to guarantee and declare that the product meets the essential requirements, affix a CE Marking to the product and, if necessary, draft and sign the EC declaration of Conformity and present the technical documentation to the national supervisory bodies. The name and address of the European authorised representative and manufacturer should be affixed in the immediate vicinity of the CE Marking on the product
The authorised representative is explicitly appointed by the manufacturer and can, instead of the manufacturer, be addressed by the authorities of the Member States with regard to the manufacturer’s requirements under the Directives.
9) Drawing up an official Declaration in compliance with the requirements out of the applicable Directive(s).
To affix the CE marking, the responsible party must set up a EC Declaration of Conformity
The EC Declaration of Conformity is a document in which the manufacturer (or his Authorised Representative) or importer declares that the equipment conforms with the essential requirements of the relevant Directive (s). The declaration contains the following main elements:
Company name and complete address of the manufacturer and, where appropriate, his Authorised Representative.
1. Equipment identification (name, function, model, type, serial number and trade name and any relevant additional information.
2. The Directives concerned and where appropriate harmonized standards or other technical standards and specifications
3. When appropriate the name and address of the person who is responsible to compile the technical file in the Community,
4. When appropriate name, address and identification number of the notified body
5. Identity and signature of the person authorized to act on behalf of the manufacturer or his representative to compile the declaration
6. The date on which the declaration is issued
7. Technical File
10) If applicable, affixing the CE marking in a correct manner.
The CE Marking must be affixed by the manufacturer or his authorised representative, with the firm name and the address of the manufacturer or his authorised representative.
The CE Marking must be visibly, clearly readable and permanently affixed to the product or type plate. If this is not possible or not allowed due to the nature of the product, then the sign must be affixed on the packaging, if this packaging exists, and on the accompanying documents, when the applying desires such documents.
If a Notified Body, in conformity with the applying Directives, is involved in the production control phase, then the CE Marking should be followed by the identification number of that Body. The identification number is affixed under the responsibility of the Notified Body by the manufacturer or his authorised representative located in the Community.
How long does the CE marking process take?
The duration of the CE marking process depends on various factors. It first depends on the type of equipment and the fact to what extent the equipment meets the essential requirements in compliance with the applicable Directives. In some cases, the essential requirements can only be determined on site at the responsible party, this has an influence on the time frame and the period required for the certification.
The total duration of the CE marking process is also dependent on the party responsible for the modifications to the equipment to bring the equipment into conformity with the essential requirements of the applicable Directive.
Who can apply the CE-marking for me?
This is different for each equipment. For a large number of equipments with a low safety risk, the manufacturer can determine whether it meets the essential requirements out of the related Directives as long as the procedures are correctly followed. Equipment with a higher risk should be tested and verified by an external examination institution.
Next to the CE certification, our partner, Certification Experts, also performs the other national and international certifications, such as the Canadian CSA certification, UL, IEC standards and the Chinese CCC certification. These certifications are made for the international business community. The great advantage for non-European manufacturers is that after the investigation and the necessary alterations to the equipment they can be sure that the equipment is safe and reliable to be sold on the European market.