CE marking step by step
The CE marking scheme applies to specific product categories where the product is considered to pose a potential risk to consumers or manufacturers. Correct CE marking gives a product market access and allows it to circulate freely throughout the EU and EEA.
You can read more about the CE marking scheme in the section Labelling and certification schemes.
Questions to ask before you start
- Who is responsible for placing the product on the market for the first time in the EU and EEA? What is your role? By defining whether you are the manufacturer, importer, importer with manufacturer responsibilities, distributor or authorised representative, you can clarify who is responsible for what in the CE marking process.
- What functionality does the product offer, and what is its intended use? Who is the product intended for? Is it for industrial or private use?
Your answers to these questions determine which regulations apply to the CE marking of your product.
If you manufacture products either within or outside Europe and sell them under your own name and trademark, you are responsible for preparing the documentation, carrying out the necessary tests and affixing the CE marking to the products. The same responsibility applies to importers who sell products made by a manufacturer outside the EU.
If you import from a manufacturer within the EU and resell the product to either an end customer or a distributor, the EU manufacturer that first placed the product on the market is responsible for ensuring that it is correctly labelled and that the documentation is in order. As an importer, you must always check that the manufacturer's documentation and labelling are in order, even if they placed the product on the market first. You will be held liable if anything is incorrect.
As a distributor – someone who sells products on behalf of others under their name and trademark – you are responsible for providing the necessary documentation if requested by the authorities or regulatory bodies. You should therefore know which products in your portfolio require CE marking and what documentation and labelling must accompany them.
As a rule of thumb, whoever signs the documentation is responsible, whether they are the manufacturer or company, importer, distributor or authorised representative.
Here, we outline a simplified, high-level process for CE marking a product. Keep in mind that this process may not reflect the complexity involved for your product.
How to CE mark a product
The most critical point in the entire process is identifying the right regulations and requirements for your product. If you are unsure, now is the time to seek advice or arrange a consultation.
On the European Commission's website you can find an overview of all product categories that require CE marking. For each product category, you will find details of the applicable directives or regulations, the standards used to assess the product, and the procedures you need to follow for the conformity assessment.
A directive is an EU document that sets out the product safety requirements. Each directive lists the applicable standards. A standard is a document containing technical specifications that describes in detail how the product can meet the requirements of the directives. These are also known as harmonised standards, where ‘harmonised’ means that the products are covered by a common set of technical rules.
Harmonised standards provide a reliable way to meet the requirements of directives and regulations. You can meet the requirements in other ways, but this may involve additional documentation and a risk of non-compliance if your product is subject to market surveillance. You can find relevant harmonised standards listed on the same European Commission pages. You can also purchase standards from Standards Norway, which offers a dedicated purchasing guide to help you identify the relevant standards for your product.
Please note that several directives may apply to a single product, and that new directives may be introduced in the future which the product must comply with.
Various Norwegian supervisory authorities and government agencies are responsible for providing information about current EU regulations and can help you identify the directives and standards you can or should follow. See an overview of the authorities and their respective areas of product responsibility. The website of the Norwegian Product Contact Point can also help you identify which authority can provide information about the regulations that apply to your product area. If you are still unsure, contact the Norwegian Product Contact Point.
The individual directives and regulations also specify which products require conformity assessment by an independent third party, known as a Notified Body, or 'teknisk kontrollorgan' in Norwegian. This applies, for example, to the CE marking of medical devices and hazardous machinery.
Notified Bodies are designated by the authorities and are usually accredited, meaning they are officially recognised as having the expertise and capability to test and assess the relevant product in accordance with applicable regulations.
You can find an overview of Notified Bodies on the European Commission's website. You can sort Notified Bodies by country, product category and the EU directives that apply to your product. As a manufacturer, you can choose any Notified Body designated by the authorities as competent in your product area. The Notified Body you choose does not need to have a presence in your country.
To CE mark your product, you must carry out a conformity assessment. This means assessing whether your product complies with the technical requirements set out in the regulations.
How you carry out a conformity assessment depends on your product and the directives and regulations you need to follow. The different approaches are known as procedures. In practice, all procedures involve preparing documentation that shows the product meets the technical requirements. You can find the required conformity assessment procedure in the legislation that applies to your product.
For the conformity assessment, the manufacturer's own assessment may be sufficient, but you may also need to involve a Notified Body.
Even if you are not required to use a Notified Body, you may still need to use an external testing laboratory to carry out the necessary tests in accordance with the relevant standards.
Technical documentation includes all documentation showing that the manufacturer has carried out the necessary assessments and tests and can confirm that the product's technical characteristics comply with regulatory requirements and standards.
Each regulation specifies what the technical documentation must contain. The technical documentation may include technical drawings, the manufacturer's statement on compliance with essential requirements, the standards applied, test results, instructions for use and safety instructions.
Please note that, for lists of contents, warnings and instructions for use, most EU countries require products sold to consumers to be labelled in the national language. It is often advisable to label the product in several languages.
The manufacturer must retain the technical documentation and keep it available for at least 10 years, updating it whenever changes are made. If the authorities carry out an inspection, all technical documentation confirming that the product has been CE marked in accordance with the applicable requirements must be available for inspection and review.
Based on the conformity assessment, you must draw up a Declaration of Conformity. This is the manufacturer's declaration that the product has been assessed and is considered to meet all the requirements of the relevant legislation.
A Declaration of Conformity should not be confused with a Certificate of Conformity, which is a test certificate issued by a Notified Body after it has carried out the required tests.
There are no requirements for the format of a Declaration of Conformity, but there are requirements for what it must contain. These are set out in the relevant legislation.
A declaration of conformity usually includes the manufacturer's name and address, a product description, references to the relevant directives and standards followed, an explicit statement of conformity, the identification number of the notified body if it was involved in the process, and technical documentation showing that the correct conformity assessment procedure has been completed. The manufacturer must also sign the declaration of conformity.
If you sell the product without the correct documentation, you will normally risk a sales ban or the product being stopped at customs.
As an importer, you need the declaration of conformity both to sell and to import the product. If you replace the manufacturer's name with your own company name, you are considered the manufacturer and are responsible for drawing up the declaration of conformity and keeping all technical documentation available.
Remember, if something happens and the authorities request technical documentation, you will have only a few days to provide a complete technical file demonstrating that the product meets all requirements.
You must affix the CE marking to the product itself so that it is clearly visible, legible and difficult to remove. If this is not possible, you can affix the CE marking to the packaging, instructions for use or accompanying documentation.
In addition to the CE marking, you must include the identification number of any notified body involved. If a product is covered by several directives and several notified bodies are involved, one of them must coordinate the procedures. You must only include the identification number of this notified body.
There are also requirements for the graphic design of the CE marking. A separate marking directive governs the design of the CE marking. Unless otherwise specified, the marking must be at least 5 millimetres high and comply with the specified proportions.
How is the CE marking checked?
Norwegian regulatory authorities may carry out spot checks to verify whether products bear the CE marking. They will check that the CE marking has been applied correctly and that the marked products meet the relevant requirements.
Customs authorities can also use CE marking when inspecting goods shipped across borders.
As an importer, distributor or authorised representative, you are responsible for checking that the product has not been incorrectly CE marked. You can use an independent third party, such as a Notified Body, to review the documentation.
Consequences of inadequate documentation and incorrect labelling
If the authorities carry out a market inspection and find products that do not meet the CE marking requirements – for example, because documentation is missing, incorrect or incomplete – they may require the manufacturer to withdraw the product from the market. This also applies if a market surveillance authority tests a CE-marked product and finds that it does not meet the regulatory requirements.
Importers and distributors in the markets you export to must notify the relevant national authorities if they discover that your product does not meet the CE marking requirements. Similarly, importers and distributors in Norway must report to the Norwegian authorities if a product in their portfolio fails to meet the CE marking requirements.
If you fail to comply with the regulations, the responsible party may be required to take corrective action, pay a penalty or stop selling the product. At border control, goods without the required documentation or with incorrect labelling will be denied entry to the market. If a product without the required documentation or with incorrect labelling causes an accident or harm to a consumer, serious liability issues may arise.
Missing documentation can also lead to lost opportunities in tender processes.
Please note that producing new documentation can take several months.
Remember that many, but not all, products must carry the CE marking. It is prohibited to affix the CE marking to a product that is not subject to CE marking requirements.