We take you through the ten steps of the procedure, step by step, and introduce you to the principles of CE marking of a product. CE marking is not just about affixing a CE mark to a product. When you CE mark, you also assume responsibility that your product complies with the law.
Please note that the individual steps include different instructions, because what should be done depends on the individual product and the directive(s) applicable to the product. Therefore, the following steps should always be read in conjunction with the directive. As an example, we can refer to construction products where special conditions may differ from the following indicative steps.
We take you through the ten steps of the procedure, step by step, and introduce you to the principles of CE marking of a product.
1. Find the EU directive applicable to your product
First, check whether the product is to be CE marked.
On the list of product groups, you can see if your product has to be CE marked. It will also appear from the list if there are products that are exempted from the directive – e.g. the Toy Directive states that jigsaw puzzles containing more than 500 pieces are exempted, as a puzzle with that many pieces is not considered as a toy.
Please also be aware that a product may be covered by more than one directive. For example, an electrical meat grinder will be covered by the Machinery Directive and the Low-voltage Directive as well.
2. Check the date applicable to CE marking of your product
The date on which the CE marking is a requirement for your product can be found in the directive. The same date applies to all products covered by a directive. When a new directive or a revision of an existing directive enters into force, the date by which CE marking must be applied will be specified in the directive.
However, CE marking of construction products differs in this respect. The dates are determined in relation to the concrete construction products and differ from product to product. The dates are determined when the European standard is harmonized in the Official Journal of the European Union. The dates relating to construction products are therefore to be found for the individual product in the EU list of harmonized construction product standards.
3. Find the conformity assessment procedure for your product
The conformity assessment procedure can be found in the specific directive. This is because the procedures may be different and vary from directive to directive. In most cases, manufacturers can carry out the conformity assessment themselves, but if the directive states that a third party is required, the manufacturer shall leave it to one of the notified bodies designated for the area to carry out the conformity assessment. You can find the list of notified bodies here.
4. Ensure that your product complies with the essential requirements of the directive
The EU directives for CE marking have been prepared to include essential safety requirements for the products. As a result, part of the process of CE marking is to address the essential safety requirements of the directive (s) applicable to the product. All essential safety requirements shall be complied with before CE marking can be carried out, but as the directives include a product group, safety requirements that are not relevant to the specific product may exist. For example, there might be a requirement for limiting "noise" in the directive for the product group, but if the specific product does not emit "noise", then this essential safety requirement is not relevant in the particular case.
If a harmonized standard is available, it is a convenient place to find essential requirements. This is because the harmonized standards contain the essential requirements and thus provide presumption of conformity, i.e. complying with the requirements of the standard entitles the manufacturer to assume compliance with the requirements of the directive.
5. Check if there are standards applicable to your product
A standard can include, for example, a description of how a machine is to be designed to avoid crushing hazards or how to surface treat toys for young children. The standard can also be product specific and, for example, provide an appropriate design for an electric hospital bed.
Find the harmonized standards.
However, a harmonized standard for the specific product with the description of the CE marking does not always exist. In this case, the manufacturer has to find other ways to meet the requirements of the directive: For example, to find a standard for another similar product or parts from other standards.
In the case of construction products, it is simpler. A harmonized standard is required here for the manufacturer to be able to CE mark at all. However, if you have a construction product that you voluntarily want to CE mark, but where there is no harmonized standard, it can be done by means of an ETA. ETA stands for European Technical Approval. Read more at www.etadanmark.dk. The ETA serves as a basis for the preparation of a declaration of performance and is thus an important step towards CE marking.
6. Prepare the technical documentation (technical dossier)
It is the responsibility of the manufacturer to prepare the technical documentation. The technical documentation, sometimes also referred to as the technical dossier, shall document that the product complies with the requirements of the directive. The requirements for what the technical documentation is to contain are given in the individual directive. If more than one directive applies to a product, the technical documentation shall satisfy the requirements of all directives.
As a general rule, documentation should cover the design and functioning of the product.
Examples of technical documentation:
Name and address of the manufacturer, and information, if any, on place(s) of origin Design and manufacturing drawings List of standards used Risk assessment Test reports, if any Instructions for use Declaration of Conformity/Declaration of performance
As a general rule, the manufacturer shall retain the technical documentation – and be prepared to make it available to the authorities – for at least 10 years from the last date on which the product was manufactured and placed on the market. The requirement as to how long the technical documentation is to be retained may vary. You will find the period in the directive concerned.
7. Complete the declaration of conformity
When your product is ready to be marketed, you will need to prepare a so-called declaration of conformity. It shall include information on directives, standards or other normative documents, information on the manufacturer's contact details and details of any third party or notified body.
With the technical documentation and the declaration of conformity, you declare that it is your responsibility, as a manufacturer, that the product complies with the requirements of the directive and that you confirm that you have carried out all the necessary assessments, e.g. risk assessment.
8. Check if there is national legislation in the country in which the product is to be sold
One of the purposes of CE marking is to ensure free movement of goods within the EU and EEA countries. In this context, the CE mark is comparable to a travel pass. This means that the national authorities in the EU cannot impose stricter requirements on a product than what the Member States have agreed. However, please note that in the individual countries there may be special requirements for the product in the situation of use. For example, there may be special requirements for servicing of lifts. Finally, the customer can always specify requirements that go beyond the requirements of the directives or regulations. Find more information about the legislation of each country at the Internal Market Centre.
9. Affix the CE mark to the product
Where the CE marking is to be placed, and how the CE mark is to be designed, may vary depending on the product in question. The detailed instructions for the position, contents and design are given in the harmonized standard. In the absence of a harmonized standard, the general instructions given in the directive are to be applied.
The CE mark has been affixed to the product, but is there anything more to be done? No, because there may be other harmonized legislation to be followed, but which does not directly relate to the CE marking. This may be, for instance: The WEEE directive, which covers all electronic products, packaging directives, the REACH Regulation or the battery directive. Therefore, check the applicable law relating to your product.
Which product groups are to be CE marked?
There is a range of products and equipment that must have the CE mark before they can be placed on the market, sold and put into use in EU and EEA countries. These include toys, machinery, electrical appliances and medical products. A product may be covered by several directives, just as one directive may cover many products.