CE Marking. Made Easy.

The CE marking offers opportunities, but can be complex. Our CE Marking Toolbox will empower you to take control, and to get the CE mark quickly and cost-effectively.

Start
CE Marking Tools & Tutorials

CE Marking. Made Easy.

The CE marking offers opportunities, but can be complex. Our CE Marking Toolbox will empower you to take control, and to get the CE mark quickly and cost-effectively.

Start CE Marking Tools & Tutorials

“At cemarking.net we believe that manufacturers are the true product experts. We believe that, with a little guidance, they can take charge of CE marking and do self-certification. That is why we’ve founded this site and community, and I am glad so many SME’s are reaching results with it.”

Han Zuyderwijk, Founder cemarking.net

CE Mark / CE Marking Quick Guide


 
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.

Please note:

  • you cannot affix the CE mark to products which are not covered by the relevant European directives;
  • by affixing the CE marking, you take full responsibility for your product’s compliance with the requirements of the relevant directives;
  • other markings may be affixed to the product as long as that such markings do not create confusion with the CE marking in form or meaning.

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

The CE mark on a grid

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

The CE mark sometimes is accompanied by a four-digit number. This is a reference number of the Notified Body that has been involved in the conformity assessment process.

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

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.

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.

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.

As indicated, products with that bear the CE mark have a free access to the market in the sense that the authorities are not allowed to require all kinds of requirements to be fulfilled. However, that does not mean that the authorities have no right to investigate the product’s compliance. Not only can they investigate, but they can also take measures against infringements. These measures may include withdrawal, recall of products, penalties and criminal sanctions (such as fines and imprisonment) wherever necessary.

Please note that there is not a single, European Union enforcement agency or service. Enforcement of CE legislation is performed by national market surveillance authorities, in accordance with the national laws and procedures of the Member States of the EU. These national market surveillance authorities work together closely, sharing information about non-compliant and unsafe products, as well as coordinating their market surveillance campaigns. If a non-compliant CE marked product is discovered in one market, all the other market surveillance authorities will be informed it by the next morning.


 

Here at cemarking.net you will find information and resources to answer questions like:

As well as information and explanations about CE marking related requirements such as:

“I need a quick and efficient way to be able to issue CE conformance certificates to my customers, while being confident that we have done the process correctly and in the approved format. Your system allow us to get to the end result in a much more focussed way and time scale than by researching it ourselves. Why re-invent the wheel when someone has done it already? Also, building up the expertise in house is much more valuable than outsourcing it each time.”

Rick Booth, DMS, United Kingdom

Frequently Asked Questions About CE Marking:

What does the CE marking on a product indicate?

By affixing the CE marking to a product, the manufacturer declares on his/her sole responsibility that the product is in conformity with the essential requirements of the applicable Union harmonisation legislation providing for its affixing and that the relevant conformity assessment procedures have been fulfilled. Products bearing the CE marking are presumed to be in compliance with the applicable Union harmonisation legislation and hence benefit from free circulation in the European Market.

Is a product affixed with the CE marking always produced in the EU?

No. The CE marking only signals that all essential requirements have been fulfilled when the product was manufactured. The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Union. Consequently, a product affixed with the CE marking may have been produced anywhere in the world.


Are all CE marked products tested and approved by authorities?

No. In fact, the assessment of the conformity of the products with the legislative requirements applying to them is the sole responsibility of the manufacturer. The manufacturer affixes the CE marking and drafts the EU Declaration of Conformity. Only products which are regarded as presenting a high risk to the public interest, e.g. pressure vessels, lifts and certain machine tools, require conformity assessment by a third party, i.e. a notified body.

What are the sanctions for counterfeiting the CE marking?

The procedures, measures and sanctions that apply to counterfeiting of the CE marking are laid down in Member State’s national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation before being obliged to take the product off the market.


Where should the CE marking be affixed?

The marking shall be affixed either to the product or to the product’s data plate. When that is not possible due to the nature of the product, the CE marking shall be affixed to the packaging and/or to any accompanying documents.

Who supervises the correct use of the CE marking?

In order to guarantee the impartiality of market surveillance operations, the supervision of the CE marking is the responsibility of public authorities in the Member States in cooperation with the European Commission.


“Your website and courses are extremely helpful to a small start-up company like ours. Many thanks for providing us access to this information.”

Joe S'Silva, Patients and Consumers’ Pharma, USA

Stay Ahead.

The CE marking rules are constantly updated to the latest state of the art in technology. Even though your product complies today, it may not tomorrow.
We also provide training and tutorials to keep you and your team in the know.

Let’s Go
Stay informed of CE marking developments

Stay Ahead.

The CE marking rules are constantly updated to the latest state of the art in technology. Even though your product complies today, it may not tomorrow.
We also provide training and tutorials to keep you and your team in the know.

Let’s Go Stay informed of CE marking developments

“This system you have is very good and I am so glad we are able to work with you on our CE compliance.”

Luke Vazul, KHS, USA
CE Marking Support

Support.

Need a little direction or assistance with the CE marking? We are happy to help. Click the button and we’ll show how the easiest ways to get support.

Get Support

Support.

Need a little direction or assistance with the CE marking? We are happy to help. Click the button and we’ll show how the easiest ways to get support.

Get Support CE Marking Support

“At first I hesitated to do CE self-certification, because I wasn’t sure I would be able to do it. Your system provides the templates and instructions to certify CE compliance. And with what I learned I was able to complete the CE marking within one week. It was a good investment. Your support and customer service are excellent!”

Tatiana Batache, SkateRunner, Belgium