CE Marking

What is CE Marking?

The CE marking is a key indicator (but not proof) of a product’s compliance with European Union (EU) health, safety and environmental protection directives and regulations. If your product comes under the scope of a directive requiring CE marking you must ensure the product complies with the applicable requirements and affix the CE mark before placing it in the market in the European Economic Area (EEA) (see “Countries In Which The CE Marking Is Required” below for a description of the countries that are included in the EEA). This is equally valid if your product is manufactured outside the EEA. Second hand products from outside the EEA that are placed in the EEA market for the first time, also require CE marking.

Often the CE marking is described as a trade passport because it enables the free movement of products within the European market. According to EU legislation, the EU Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product.

CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark. CE Marking.

How the CE Mark looks?

The CE mark is a marking that consist of the initials ‘CE’ in the following form:

ce_mark_big

There are no specific color requirements for the letters and background of the CE mark. In other words, it is not required to print the letters ‘CE’ in black against a white background. However, the color schemes for the foreground and background should be sufficiently complementary, so that the CE logo is clearly visible.

The minimum dimension of the CE mark must be 5 mm in height. If the size is enlarged, the letters CE must be in proportion to the standard version as shown.

Please find here example of the CE logo in different file formats:
http://ec.europa.eu/enterprise/faq/ce-mark.htm

Products that need CE Marking

Products that require to be CE marked are:

  • active implantable medical devices
  • appliances burning gaseous fuels
  • cableway installations designed to carry persons
  • eco-design of energy related products
  • electromagnetic compatibility
  • equipment and protective systems intended for use in potentially explosive atmospheres
  • explosives for civil uses
  • hot-water boilers
  • household refrigerators and freezers
  • in vitro diagnostic medical devices
  • lifts
  • low voltage
  • machinery
  • measuring instruments
  • medical devices
  • noise emission in the environment
  • non-automatic weighing instruments
  • personal protective equipment
  • pressure equipment
  • pyrotechnics
  • radio and telecommunications terminal equipment
  • recreational craft
  • safety of toys
  • simple pressure vessels

The CE marking is not required for items, for example:

  • chemicals
  • cosmetics
  • foodstuffs
  • pharmaceuticals

Countries in which CE Marking is required

The CE marking is affixed on the aforementioned products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.

The CE marking is currently required in the following countries:

  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)
  31. Croatia (since July 1, 2013)

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.

Who is responsible for CE Marking?

Persons that bear a responsibility for CE and the CE compliance of products are:

  • manufacturer (irrespective if located in our outside the EEA)
  • importer
  • distributor
  • authorised representative

If you are a manufacturer it is your responsibility to:

  • carry out the conformity assessment
  • draw up the Technical File
  • issue the EC Declaration of Conformity (DoC)
  • affix the CE mark to the product

If you are the importer a product from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available. However, if you import the product but place it in the EU market under your own (brand)name, you have the same obligations as the manufacturer.

If you are a distributor you must check the presence of both the CE mark and the user manual, product label and other necessary supporting documentation.

Organizations looking to obtain CE marking product certification in India can follow following procedure

1) Appoint consultants for CE marking – if in house knowledge about procedure is not available.
2) Identify applicable directive / standards for CE mark which are prepared by the Europeon Union
3) Perform gape analysis / Risk analysis for directive / standard requirements against feature of the product to be CE marked.
4) Do modification in the design / product aesthetic…. as applicable to fulfill gape/risk identified.
4) Get the product tested in the laboratory – in house lab/ outside lab as per directive / standard requirement
5) Prepare technical construction file.
6) Prepare declaration of conformity – DOC.
7) Get the file reviewed by certification agency and take a letter of compliance from them. It is not mandatory to do this for products which does not fall under doing CE marked by notified body. However it is recommended to do this ?

How to Get the CE Mark?

Despite what many people believe, a manufacture does not “get” the CE mark from a third party certification body or a European or national authority. The manufacturer affixes the CE marking in his own right and is allowed to do so when all requirements are fulfilled. A test or certification body may be involved in the process merely as a service provider. However, the body will not take over responsibility for CE compliance. Responsibility for CE compliance will always remain with the manufacturer (or private labeler).

The CE marking rules typically require the following steps to be fulfilled before the CE mark may be affixed:

  • Determine the applicable CE directives/regulations (You can use the CE Directive Checklist in our CE Marking Toolbox);
  • Identify the applicable European harmonized standards;
  • Identify which essential requirements of the CE marking directive/regulations apply to the product;
  • Identify which requirements of the European harmonized standards apply to the product;
  • Conduct and document the conformity assessment against the essential requirements and the requirements from the standards (this may entail visual inspection, testing etc.);
  • Machinery and medical devices require to be submitted to a risk analysis;
  • Provide the user with the information required to use the product safely (typically user manual, installation instruction, warning labels etc.);
  • Ensure consistency of production, thus proving the assessed sample and the production are identical;
  • Compile a Technical File (or sometimes called “technical documentation”) of all documents that are necessary to show compliance with all relevant requirements;
  • Draw up and sign a Declaration of Conformity (for construction products a Declaration of Performance);
  • Affix the CE mark;
  • Continuously monitor developments related to CE directives/regulations and European harmonized standards. Apply new rules and amendments where appropriate.