International Qulity Management System        Istituto Servizi Europei Technologici
Home | Sitemap
 
  Home Why CE ?   Services Directives FAQ Contact Us  
 What is a CE Marking?  
 

The CE marking is a conformity marking consisting of the letters "CE", and taking the form as shown here. CE is an abbreviation for 'Conformité Européenne', French for 'European Conformity'.

The CE marking symbolizes that a product it is affixed to is in conformity with all relevant essential requirements, and that the product compliance has been established using the appropriate conformity assessment procedure(s). The ‘essential requirements’ refer, among other things, to safety, public health and consumer protection.

CE marking is obligatory for any product covered by one or more of the so-called European ‘New Approach Directives’. Without the CE marking, these products are not allowed to be placed or to be put into service in the European Economic Area. In this regard, the CE marking sometimes is called a ‘trade passport’, because like carrying a passport when entering a country, the CE Marking is required for market access.

 

The CE marking applies to products placed in the market or put into service in the European Economic Area, and only for certain product groups or product aspects. Thus in order to determine whether the CE marking applies, two things need to be investigated:

A) Is the product going to be placed in the market or put into service in one of the countries where
    the CE marking is obligatory?

B) Is the product covered by the scope and field of application of one or more of the European New
    Approach Directives (and the national laws and regulations of the countries of the EEA that
    transpose these directives)?

     




What’s is the importance of CE mark on electronic gadgets ?  
 

CE mark on electronic gadgets show’s that the product is safe (Electrically safe) to use.

     




What documents are required for CE marking?  
 

Documents required for CE marking are:

  • Design and drawing of product
  • Process flow chart
  • Manufacturing flow chart
  • Test report
     




What kind of tests is  required for product to get CE marking?  
 

Tests depends on the type of product and directives.

     




How it helps to increase the sell of product?  
 

After CE certification we  are allowed to sell our products in Europe.

  • After CE certification we  are allowed to sell our products in Europe.
  • It shows that the product is safe (Electrically safe) to use.
     




Is CE Marking necessary to sell our product in Europe?  
 

YES.

     




Who is European representative?  
 

All non-European manufacturers ,who wish to market their products in the European market under their own name must designate a regulatory authorized Representative in order to meet CE requirements.

     




What is the function of European representative?  
 

European representative represent company in Europe, they provide assistance to your product in Europe.

     




What is a Directive?  
 

A European directive can be regarded as an European law, and - unlike it's name may assume - is legally binding for every Member State of the European Union. Through transposition into the national legislation of the Member States, persons and companies are subject to the requirements of the European directives.

     




Do Our Products Qualify for CE When They Have UL/CSA Certification?  
 

There are differences between the CE marking certification process and the UL/CSA certification. And for that reason, normally compliance with UL/CSA does not automatically give the right to affix the CE marking. However, the UL/CSA certifications may make the CE process much easier when the testing and certification were conducted according to international standards similar to European harmonized standards relevant for the particular product. In that case, it may be possible to skip (parts of) the expensive product compliance testing.

Please note however that another part of the CE requirements is aimed at the manufacturer's ability to prove CE compliance through a Technical File. This Technical File needs to be compiled before the CE marking is affixed (it is a part of the approval), and even after the product has been placed on the market, the Technical File needs to be maintained and updated on a regular basis. The UL and CSA requirements for Technical Files are different, so this would require some attention from your side as well.

Whether the existing UL/CSA files may be used for proving CE compliance can be judged by our experts after a brief documentation review. We can also help you to determine the most cost effective route to CE certification of your products. Let us know when you are interested in our services

     




In Which Countries CE is Required?  
 
  1. Austria (since 1995)
  2. Belgium
  3. Bulgaria (since 2007)
  4. Czech Republic (since 2004)
  5. Cyprus (since 2004)
  6. Denmark
  7. Estonia (since 2004)
  8. Finland (since 1995)
  9. France
  10. Germany
  11. Greece
  12. Hungary (since 2004)
  13. Iceland
  14. Ireland
  15. Italy
  16. Latvia (since 2004)
  17. Lithuania (since 2004)
  18. Liechtenstein
  19. Luxembourg
  20. Malta (since 2004)
  21. Norway
  22. The Netherlands
  23. Poland (since 2004)
  24. Portugal
  25. Romania (since 2007)
  26. Slovakia (since 2004)
  27. Slovenia (since 2004)
  28. Spain
  29. Sweden (since 1995)
  30. United Kingdom (Great Britain)

Switzerland is not a member of the European Union, but for some products it accepts the CE marking as a presumption of conformity with Swiss national technical regulations.

 

PLEASE NOTE: Turkey is neither member of the EU, nor is considered a part of the EEA. However, Turkey has fully implemented many of the European CE marking directives. This means that for many products they also require CE marking.

     




How Do You Benefit From CE Marking?  
 

The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 30 countries of the European Economic Area (EEA).

The great benefit for manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.

In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.

     




Do Your Products Need CE Marking?  
 

Unfortunately, the process of determining whether the CE marking applies to a product is rather complex. The European legislator does not provide product lists or nomenclatures which indicate the appropriate CE marking directives.
The CE marking applies to products placed in the market or put into service in the European Economic Area, and only for certain product groups or product aspects. Thus in order to answer the question whether a product needs to be CE certified, one has to determine first in which countries the products are going to be placed in the market or used. Secondly, for each single directive it must be determined whether the products, or some of its aspects, falls within its scope.

Step 1.The CE Marking Is Required Only in the Countries of the European Economic Area (EEA):
The European Economic Area (EEA) is formed by the twenty-seven Member States of the European Union (EU)...:

  • Austria (became member in 1995)
  • Belgium (Founder Member in 1957)
  • Bulgaria (2007)
  • Czech Republic (2004)
  • Cyprus (2004)
  • Denmark (1973)
  • Estonia (2004)
  • Finland (1995)
  • France (FM 1957)
  • Germany (FM 1957)
  • Greece (1981)
  • Hungary (2004)
  • Ireland (1973)
  • Italy, (FM 1957)
  • Latvia (2004)
  • Lithuania (2004)
  • Luxembourg (FM 1957)
  • Malta (2004)
  • The Netherlands (FM 1957)
  • Poland (2004)
  • Portugal (1986)
  • Romania (2007)
  • Slovakia (2004)
  • Slovenia (2004)
  • Spain (1986)
  • Sweden (1995)
  • United Kingdom (Great Britain) (1973)

...as well as three members of the European Free Trade Association (EFTA):

  • Iceland
  • Norway
  • Liechtenstein

Although Switzerland is member of the EFTA, it does not take part in the EEA.

     




Which type of product require CE Marking?  
 

The CE Marking Is Required Only for the Following Types of Products:

  • Toys
  • Machinery
  • Electrical equipment
  • Electronic equipment
  • Personal protective equipment
  • Pressure equipment
  • Medical devices
  • Active implantable medical devices
  • In vitro diagnostica
  • 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
     




Which type of product does NOT require CE Marking?  
 

The CE marking is NOT required for the following products:

  • Chemicals
  • Pharmaceuticals
  • Cosmetics
  • Foodstuffs
     




Who is Responsible for CE Marking?  
 

The CE marking requirements covers different aspects of a product’s design, production and distribution. Typically, various companies are involved in the design, manufacturing, distribution and placing on the market of products. The contributions of each single of these links in the production chain and distribution chain may affect the CE compliance of a product. For example, a product may be designed in accordance with the requirements, but may in the end not comply because during the production stage there was a deviation from the design. Or an electronic component may have been tested and approved for the requirements for electromagnetic interference, but can start to emit illegitimate disturbance when installed incorrectly. This raises the question of who is responsible for the CE marking.

The European CE marking directives, intend to make one person the main responsible and accountable for CE compliance. The way to identify that responsible person is rather unique for these directives. One would expect that the directives state that the ’manufacturer’ is responsible for CE marking. But instead they define two moments in time when the responsibility for CE starts:

According to the text of the CE directives, a product must comply with the CE requirements and have a CE marking from the moment it is:

  • placed on the Community market for the first time;
  • put into service in the Community market for the first time.

Placing on the market is the initial action of making a product available for the first time, either for payment or free of charge. Putting into service takes place at the moment of first use within the EEA by the end user.

You may ask why the European legislator chose this construction to establish responsibility. The answer is for reasons of clarity and flexibility to be able to deal with all different cases that one may find in practice. For example, if the directives would make the ‘manufacturer’ responsible, the question arises what to do if the manufacturer is located outside Europe and therefore is not subject to European legislation. And what to do with products that sold under the brand name of one company, but manufactured by another? And if the directive would make the ‘importer’ responsible, one could ask which importer: the importer in the United Kingdom, the importer in Germany, the importer in France etc.? In other words, although references like ‘manufacturer’ or ‘importer’ seem to be clear and feasible to be used to establish legal responsibility, in practice these terms turn out to be rather ambiguous.

With help from the definitions of ‘placing on the market’ and ‘putting into service’ in each practical case always one responsible person can be identified:

  • The manufacturer, when located in the EEA
  • The company that manufactures equipment for its own use (‘putting into service’)
  • The importer of products from outside the EEA
  • The importer of second hand equipment to be placed in the European market for the first time
  • A private labeler (who presents himself as being the ‘producer’)
  • The person that revises or modifies a product in such a way that it is considered to be a new product (and that product needs CE)

Therefore the conclusion is that there may be one ‘person’ bearing the final responsibility for the CE compliance. However, this person cannot ensure CE compliance without the help of all the parties involved in the design, production and distribution chain. And so we see in practice that CE marking requirements are increasingly becoming part of agreements and contracts between these parties.