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CE Mark / CE Marking Quick Guide
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.
The CE mark is a marking that consist of the initials ‘CE’ in the following form:
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:
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.
- 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
- low voltage
- measuring instruments
- medical devices
- noise emission in the environment
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- radio and telecommunications terminal equipment
- recreational craft
- safety of toys
- simple pressure vessels
The CE marking is not required for items, for example:
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:
- Austria (since 1995)
- Bulgaria (since 2007)
- Czech Republic (since 2004)
- Cyprus (since 2004)
- Estonia (since 2004)
- Finland (since 1995)
- Hungary (since 2004)
- Latvia (since 2004)
- Lithuania (since 2004)
- Malta (since 2004)
- The Netherlands
- Poland (since 2004)
- Romania (since 2007)
- Slovakia (since 2004)
- Slovenia (since 2004)
- Sweden (since 1995)
- United Kingdom (Great Britain)
- 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)
- 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:
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:
- What is CE marking?
- What does the CE mark mean? What do the initials CE stand for?
- Do your products need CE marking?
- How do you benefit from CE marking??
- In which countries is the CE marking required?
- How do I CE mark my product?
- Do our products automatically qualify for the CE mark when they are UL/CSA approved?
- Who should undertake CE marking?
- Notified Bodies: What Are They? What Is Their Role
- What is the CE marking process?
- What files / documentation must I keep?
- How and where must the CE mark appear?
- Other Posts About CE Marking
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
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“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
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“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