Category: CE Certification

Sadly, the process of determining whether the CE marking applies to a product or not is complex. The European legislator does not furnish any list of products or nomenclatures that can be used to identify the relevant CE marking directives.

The CE marking is applicable on the products put into service or placed in the market in the European Economic Area (EEA), and only for certain product groups or product aspects. Therefore, for the purpose of answering the question of whether a product needs to be CE marked, one first needs to determine in which countries the products are going to be used or placed in the market. Secondly, for each single directive, it has to be determined if the products, or some of its aspects, fall within its scope.

Step 1. In which countries the products are going to be placed in the market or used?

The CE marking is required only in the member countries of the European Economic Area (EEA). EEA is composed of twenty-eight member states of the European Union (EU):

1. Austria
2. Belgium (Founder Member in 1957)
3. Bulgaria
4. Croatia
5. Cyprus
6. Czech Republic
7. Denmark
8. Estonia
9. Finland
10. France (Founder Member in 1957)
11. Germany (Founder Member in 1957)
12. Greece
13. Hungary
14. Ireland
15. Italy (Founder Member in 1957)
16. Latvia
17. Lithuania
18. Luxembourg (Founder Member in 1957)
19. Malta
20. The Netherlands (Founder Member in 1957)
21. Poland
22. Portugal
23. Romania
24. Slovakia
25. Slovenia
26. Spain
27. Sweden
28. United Kingdom (Great Britain)

Also, there are three members of the European Free Trade Association (EFTA):

• Iceland
• Norway
• Liechtenstein

Though Switzerland is member of the EFTA, it is not a part of the EEA.

An important point to note here is that, Turkey is neither a part of the EEA nor is considered a member of the EU. However, Turkey has fully implemented many of the European CE marking directives. This means that for many products, Turkey also require CE Marking.

If the product is to be put into service or placed in the markets mentioned above, the CE mark needs to be applied if the product is covered by one or more of the European CE marking directives.

2. What are the directives in which the product falls?

The CE marking is essential for the products for which a CE marking directive or regulation has been established. There are directives/regulations for the following types of products. There can be more than one directive/regulation that can apply to a single product. The directives for CE Marking are:

• Toys
• Machinery
• Electrical equipment
• Electronic equipment
• Personal protective equipment
• Pressure equipment
• Medical devices
• Active implantable medical devices
• In vitro diagnostics
• Radio and Telecommunications terminal equipment
• Simple pressure vessels
• Gas appliances
• Lifts
• Recreational craft
• Equipment and protective systems for use in explosive atmospheres
• Non-automatic weighing instruments
• Cableways
• Construction products
• Explosives for civil use
• New hot water boilers
• Measuring Equipment

The CE mark is NOT required for the following products:

• Chemicals
• Pharmaceuticals
• Cosmetics
• Foodstuffs

Products not covered by the European CE marking directives, might fall within the scope of other European or national legislation. But if there is no specific legislation, the General Product Safety Directive (2001/95/EC) may apply. This European Directives demands that the products are safe, but is does not require any marking.

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The member countries of the European Union (EU) take for granted that the products bearing the CE mark comply with all the provisions of the applicable directives. Consequently, the placing of the products bearing the CE Mark in the market shall not be prevented, restricted, or prohibited until and unless the provisions relating to the CE marking are enforced incorrectly.

Products covered under the New Approach Directives have the CE Marking. The CE Mark therefore implies that the products comply with the essential requirements of the relevant directives and that they are subject to the conformity assessment processes specified in those directives. On this basis, the member countries of the European Union are obligated to take adequate measures to protect the CE marking.

The New Approach directives are applicable to the products intended to be offered to consumers for the first time within the EU. In general, these products are either ready-to-use or require adjustments that can only be made for their intended use. In brief, the directives are applicable on new products manufactured in EU member countries and on the new products imported from third countries or second hand products. The concept of product varies among the New Approach directives. For example, the directives include, accessories or systems, materials, equipment, assemblies, apparatus, components or safety components, devices, tools etc. Thus, the manufacturer must check if a product is covered by more than one directives.

Products which are subject to significant changes are treated as new products and they must comply with the provisions of the respective directives before being presented in the markets of European Union countries. Products which have been refurbished without altering their original shape, performance and intended use are not subject to conformity assessments as per the New Approach directives.

The basic requirements outlined by the New Approach directives may complement or overlap each other, subject to the hazards covered by those conditions associated with the product up for discussion. Where the same product or hazard falls within the scope of more than one directives, the application of other directives can sometimes be excluded by performing a risk analysis of the intended use of the product that is defined by the manufacturer.

Manufacturers outside or within the EU are liable for affixing the CE Mark on the products covered by the New Approach Directives. In general, there are 6 steps to CE certification process:

1. Identifying the directives or directives to which the product applies. The first step is to determine which directives the product falls under.
2. Identify the requirements of the directive(s) for the product. Each directive details out what is legally required for product compliance.
3. Determine the need for third-party assessment. Some directives require that products be tested and approved by a third-party organization to ensure compliance with the applicable basic requirements.
4. Evaluation of product suitability. The directives consist eight conformity assessment modules. These modules are applicable to a specific product category and are identified as follows:
   • Module A Internal production control,
   • Module B European Union type examination,
   • Module C Type compliance,
   • Module D Production quality assurance,
   • Module E Product quality assurance,
   • Module F Product verification,
   • Module G Unit verification and,
   • Module H Full quality assurance.
5. Preparing and storing technical files. Producers are required to create a technical dossier containing documents and information indicating that the product complies with the directive requirements and keep it for a minimum period of 10 years from the date of manufacture.
6. Making a declaration of conformity and affixing the CE mark. The declaration of conformity proves that the product complies with the mandatory safety requirements and is established on the basis of technical file.

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