Step 5: Confirm Compliance - Declaration of Conformity and CE Marking
Introduction to the Declaration of Conformity
Please watch the introductory video on the Declaration of Conformity and the affixing of the CE marking below:
To start the lesson, click the “Start”-button below.
You may also like this video that shows two examples of the Declaration of Conformity.
The CE marking directives impose an obligation for the manufacturer, or his authorized representative established in Europe, to draw up a Declaration of Conformity when the product is placed on the market in Europe. The Declaration of Conformity must ensure that the product satisfies the essential requirements AND the appropriate conformity assessment procedures of the applicable directives.
The Declaration of Conformity must be kept for at least ten years from the last date of manufacture of the product unless the applicable CE directive arranges otherwise. This is the responsibility of the manufacturer or his authorized representative in Europe.
The Declaration of Conformity must be made available to the market surveillance authority immediately upon their request. And the directives relating to machinery, potentially explosive atmospheres, recreational craft, and lifts require that each product is accompanied by the Declaration of Conformity. That means that for these products you need to send the Declaration together with the product.
Language of the Declaration of Conformity
The Declaration of Conformity must be drawn up in one of the official languages of the European Union. For products, which are required to be accompanied by the Declaration of Conformity, it must be in the language of the country of use. In these situations, a translation has to be provided by the manufacturer, his authorized representative, or the distributor. Additionally, a copy of the declaration in the original language has to be supplied.
Content of the Declaration of Conformity
The contents of the Declaration of Conformity are laid down in the concerned directive (or directives).
As a minimum the following information must be included:
- the name and address of the manufacturer or his authorized representative issuing the declaration;
- the identification of the product (name, type or model number, and any relevant supplementary information; e.g. lot, batch or serial number, sources, and numbers of items);
- the referenced standards or other normative documents (e.g. national technical standards and specifications) in a precise, complete, and clearly defined way;
- all supplementary information that may be required (e.g. grade, category), if applicable;
- the date of issue of the declaration;
- signature and title or an equivalent marking of authorized person;
- the statement that the declaration is issued under the sole responsibility of the manufacturer and, if applicable, his authorized representative.
Sometimes other information is required, such as:
- the name, address, and identification number of the notified body when it has been involved in the conformity assessment procedure;
- and the name and address of the person who keeps the Technical File.
Prepare the Declaration of Conformity
To prepare a Declaration of Conformity for your product(s) you can use the tool we offer in the Menu Bar (‘EU Declaration of Conformity’), or simply ask your coach. Please note that after submitting the form, our staff will first check the content in order to make sure it is correct. Therefore, please do not expect to receive the template immediately.
Affixing the Conformity Marking
The affixing of the CE marking to a product may only be done by the manufacturer or his European authorized representative. By affixing the CE marking the manufacturer indicates that the product complies with the applicable CE requirements and that the appropriate conformity assessment procedures have been followed to ensure CE compliance.
In principle, the CE marking may not be affixed until the conformity assessment procedure has been completed, and it has been verified that the product complies with all the provisions of the relevant directives. Usually, this will be at the end of the production phase. And there is no problem with that if, for example, the CE marking is on a data plate that is not affixed to the product until after the final inspection.
But, if the CE marking is affixed by stamping or casting or in any other form so it becomes an inseparable part of the product or of a component, it may be necessary to affix the marking in another stage of the production stage. Or think about the situation where the CE marking is printed on the packaging or the accompanying documents. The packaging often has to be ordered from the printer even before the production has started. This is not against the rules, as long as the manufacturer realizes that as soon as he is shipping out with CE marking, the product needs to be compliant.
It’s perhaps needless to say that it is not allowed to affix the CE marking to products that do not comply. But you can also not put the CE marking on a product that does not fall within the fields of application of the CE marking directives. That is also a criminal offense that may be prosecuted.
Form and Dimension
As you know very well already, the CE marking consists of the letters C and E and it takes the form as shown here. If the CE marking is reduced or enlarged the proportions must be respected. Where the applicable directive does not impose specific dimensions, the CE marking must have a height of at least 5 mm.
Misuse of the Conformity Marking
The affixing of other markings (for example private certification marks) in addition to the CE marking, is allowed, provided that these markings or marks do not create confusion with the CE marking and that they do not reduce the legibility and visibility of the CE marking. A reason to ban other markings is that these could be deceiving both as to the meaning and form of the CE marking and that it may be confused with it. The decision of whether or not another mark is confusing and, thus, deceiving must be decided from the point of view of consumers, users, market surveillance authorities, and other third parties likely to come into contact with such a mark.
To avoid confusion with CE marking, other legal markings or private certification marks must fulfill a different function compared to that of the CE marking. In other words, they must signify conformity to a set of regulations or standards that are different from those with the CE marking expresses conformity with. Furthermore, these markings and marks must have an added value in relation to the requirements of the directives in a general sense: the basis for delivering these markings and marks has to be clearly beyond the essential requirements, harmonized standards, conformity assessment procedures, and documents accompanying the products as required by the applicable directives.
‘Chinese export marking’
Just recently, there were rumors of a marking with the letters CE. Clearly, the marking resembles the CE marking very closely. The two letters C and E are placed closer together. And these rumors suggested that the marking was even intended to deceive the consumers and users for the CE marking, but when asked for the meaning of the marking was said to be a China Export-marking.
No China Export marking exists. The European Commission even saw itself forced to respond to the rumors with an official communication.