Here, we will present to you a detailed and interesting description of how the CE marking process works within the European Union. How do you get products from development to market in the most efficient, and legal, way? Continue to read, and you will find out.
But, if you don’t want to read complicate and long descriptions, just check out our simple infographic about the CE marking process.
The CE marking process has the following steps:
- Identifying the applicable EU directives
- Selecting standards
- Notified bodies
- Testing for the CE mark
- Technical file
- Declaration Of Conformity
- Marking/ labelling products
First, let’s clarify what the EU directives and harmonised standards are.
The EU directives detail the essential requirements a product must meet to be sold within the EU. A directive is a pronouncement, to encourage all EU members, to implement the directive as a national law. Therefore, all directives have or will be implemented in national law, regulations, and provisions – these are the rules you as a manufacturer, importer or distributor must follow.
The directives, laws, regulations, and provisions, however, are legal documents and can sometimes be a bit hard to interpret. In this regard, there are technical standards that can make life easier for the manufacturers. The technical standards specify the necessary requirements and technical specifications the product must comply within to meet the safety requirements in the directive.
For each directive, a number of standards have been “approved” to cover the essential requirements in the directive. These are called harmonised standards. A standard can be harmonised with one or several directives, which means that if the product meets the technical requirements in the standard, it automatically meets the essential requirements in the directive. This usually makes life easier since there is no need to interpret the legal text of the directive.
Identifying the applicable EU directives
Identifying the applicable directives for your product is the most important step in the entire CE marking process. A product will often come under more than one directive. However, a manufacturer may not CE mark the product against two security directives simultaneously. For example, a waste disposer that could be marked against either the LVD or the Machinery Directive must be CE marked for the directive that is most suitable for the product. The CE Check digital service can help you with that.
Additionally, there are several other directives a manufacturer may need to consider. These often concern environmental and sustainability issues. For instance, WEEE, REACH, the Batteries Directive, and the Packaging Directive.
To determine which directives apply to your product, start by considering the following questions:
- Who will use the product?
- What are the conditions for installing/using the product?
- Is the product intended for home or industrial/agricultural use?
- For which EU countries is the product intended? (Some states still have certain national stipulations)
If unsure which directive applies to your product, we recommend you to use our digital CE marking service, and it will automatically find the directives applicable to your product. You can also contact a notified body, supervisory authority or national accreditation body.
Once you have identified which EU directives apply to your product, it is your responsibility as a manufacturer or importer to prove that the product meets the requirements of these directives. That’s easily done by following the harmonised standards and comply with the requirements and technical specifications.
When a product meets the relevant requirements in a harmonised standard, it is granted its presumption of conformity. Therefore, if it complies with all the requirements of the standards, it complies with all the requirements of the corresponding EU directives as well.
It is not compulsory to use the standards as a foundation for ensuring the product compliance with the CE directives. However, it’s absolutely the easiest way. But you’re free to ensure compliance in other ways too.
A notified body is an EU organisation that assesses the CE conformity of certain products. These bodies carry out tasks related to conformity assessment, such as a review of the technical file and test reports. Each EU directive will state whether you need the assistance of a notified body to fulfil its requirements or not. It’s crucial that you know what the applicable directives demand because the notified body assessment is not mandatory for all products. The CE Check service will identify and let you know if you need a Notified Body for your product’s CE marking process.
If you need to involve a notified body, it is advisable to have a consultation with them as early as possible. Doing so enables you to receive expert help early in the CE marking process, which simplifies the subsequent work and saves you time.
Testing for the CE mark
Now you must test the product to verify that it meets the requirements of the EU directives. Depending on the requirements in the respective CE directive, you can either perform the tests in-house or at a third-party laboratory. This phase will often involve conducting a risk analysis of the product.
- What are the hazards which the product associates with?
- Are there any risks to people, animals, other goods or the environment?
- What are the solutions for minimising risks under the specific CE directive?
As a manufacturer or importer, you must compile the technical documentation. The CE directive/s contain a detailed description of it. This documentation should prove compliance with the EU directive/s. You need to store it in the European Union for about ten years after selling the last product. If the national authorities request it, you must be able to make it available to them, along with a copy of the CE Declaration of Conformity. At CE Check, we will store your technical documentation in our cloud-based CE marking software.
Usually, a technical file includes information about design, manufacture, and use of a product. In other words, it contains everything necessary to show that the products bearing the CE marking meet with the essential requirements.
What does the technical file include?
- A general description of the product
- Information about the product design (for instance, circuit diagrams, design drawings, mechanical drawings, component list, manufacturing documentation, etc.)
- Description and explanations that could help understand the abovementioned drawings.
- Installation description and user manual for the product. The installation description must clarify the steps for installing and way of using the product. The language of the user manual must be in the language of the country where you plan to sell the product.
- A list of all the standards you’ve used for the CE marking process either fully or partially, or your own standards/methods for verifying compliance with the respective CE directive.
- Other documents, such as calculations, simulations, etc.
- Test reports
The manufacturer/importer must keep copies of the technical file for a period of usually ten years after placing the last product on the EU single market. This timeframe may vary depending on the directive.
Declaration Of Conformity
When the technical file is ready, the manufacturer/importer must guarantee that the product meets the requirements of the specified EU directives and relevant standards. You can do that by writing and signing a Declaration of Conformity.
The Declaration of Conformity is a legal document by which the manufacturer of a product certifies that the product fulfils the essential requirements in the applicable CE directives. The person responsible for passing the CE marking should sign the document. That’s usually the CEO or the product owner.
What to include in the Declaration Of Conformity?
- Name and address of the manufacturer/importer issuing the declaration.
- Identification of the product (name, type number or model number, as well as all relevant additional information, such as serial number).
- Reference in an exact, complete and clearly defined manner to the applicable CE directives, which part of the CE marking process.
- The harmonised standards/methods used to verify that the product complies with the requirements of the directives. These must be accurately, completely and clearly defined
- The date of issue of the declaration, signature, and title of CEO or equivalent.
- A declaration that the manufacturer/representative party bears the sole responsibility that the product complies with relevant directives.
- Name, address and identification number of any Notified or third-party bodies that took part in the CE marking process
- Name and address of the person or organisation within the EU in possession of the technical documentation.
Marking/ labelling products
After passing successfully the CE marking process, you as a manufacturer/importer need to create the CE marking. The CE marking must be visible on the product (or on the packaging if the product itself lacks sufficient space). This marking and the Declaration of Conformity, together testify that the product meets the requirements of the applicable CE directives.
CE labelling rules
- The CE marking must consist of the letters “CE” in the design as shown here.
- If the CE marking is reduced or enlarged, the proportions given in the picture are maintained.
- The CE mark must be visibly and legibly on the product.
- When it is not practically possible to CE mark the product itself (due to size or design), you can place the CE marking on the packaging and accompanying documentation instead.
- The marking must be durable so that it can resist to external factors.
- The different components (letters) of the CE marking should be approximately equal in height and not smaller than 5 mm.
- If there is the need for involving notified bodies in the CE marking process, you need to include their identification number/s on the CE mark.