The CE marking is more than just a label on a product; it is a passport to the European market. For businesses, understanding and mastering the CE marking requirements is crucial to ensure the compliance of their products, avoid costly penalties, and most importantly, inspire consumer confidence. Whether you are a growing start-up, a well-established manufacturer, or an importer looking to access the vast European Union market, this article will provide you with all the answers you need.
As you read on, you will not only discover what CE marking is, but also how to obtain it, which products are affected, and why it is essential for the sustainability of your business. We will also discuss the mistakes to avoid and how much time should be considered and, above all, what the costs of this certification are.
This comprehensive guide is designed to provide you with all the information you need, in a clear and concise manner, so you can navigate the sometimes complex world of CE marking with confidence.
What is CE Marking?
The CE marking, often seen as a simple label on a product, is in reality much more than that. It is a symbol that certifies that the product complies with the essential safety, health and environmental protection requirements defined by European legislation. In other words, the CE marking is a guarantee for users that the product they are buying is safe to use and complies with the standards in force.
Created as part of the European Single Market, the CE marking is mandatory for many categories of products marketed in the European Economic Area (EEA) , which includes the countries of the European Union, as well as Norway, Iceland and Liechtenstein. It is also required for certain products sold in Turkey and Switzerland. The CE marking thus allows the free movement of these products across the national borders of these countries, without them being subject to new conformity assessments.
Established in the late 1980s, the CE marking aims to strengthen consumer confidence while facilitating trade within the EEA. A product bearing this marking indicates that it has undergone rigorous testing and meets applicable safety and performance standards , whether for toys, electrical equipment, medical devices, or industrial machinery.
In short, the CE marking fulfills 2 main purposes:
Ensuring the safety of users of marketed products
Facilitated the exchange of goods within the European Economic Area
Products covered by CE marking
CE marking is mandatory for a wide range of products sold in the European Economic Area. Here is a non-exhaustive list of product categories commonly affected by this regulation:
Household appliances (refrigerators, dishwashers, etc.)
Electronic equipment (televisions, computers, telephones)
Medical devices (syringes, pacemakers, imaging devices)
Toys (board games, dolls, electronic toys)
Industrial machinery (presses, forklifts)
Building materials (cement, windows, doors)
Heating systems (boilers, radiators)
Personal protective equipment (helmets, gloves, goggles)
Pyrotechnic products (fireworks, firecrackers)
Elevators
Electrical or electronic devices
Measuring devices (scales, thermometers)
Non-automatic weighing instruments
Valves and taps for use in gas networks
Pressure equipment (compressors, tanks)
Fire alarm systems
Equipment for explosive atmospheres (ATEX)
Pleasure boats
Water sports equipment (jet skis, boats)
Telecommunications equipment (modems, routers)
Automotive Emission Control Products
These examples illustrate the diversity of products that must be CE marked before being placed on the market. If your product falls into these categories, make sure it complies with the applicable European directives to ensure its free movement within the EEA.
It is therefore important to find out about your product before placing it on the market in order to check whether the CE marking applies.
Why is CE marking essential for your business?
CE marking is not only mandatory for many products sold in the European Economic Area, but it is also a key element for the success of your business. Without this certification, it is illegal to sell your products in the EEA, cutting you off from a market of over 500 million consumers.
In addition to guaranteeing access to this vast market, the CE marking certifies that your products comply with European safety and quality standards, which strengthens consumer confidence . A CE marked product is perceived as safe and reliable, which can positively influence your customers' purchasing decision.
Failure to comply with this obligation can result in severe penalties , such as fines, sales bans, or costly product recalls, seriously damaging your company's reputation and finances.
The process of obtaining CE marking
Obtaining the CE marking for a product involves following a precise process, made up of several steps. Here are the main steps to follow:
1. Define the product : Clearly identify the product and its application.
2. Identify applicable directives : Determine which European regulations apply to your product.
3. Select harmonised standards : Choose the relevant European standards to ensure compliance.
4. Carry out a risk analysis : Evaluate the potential risks associated with the use of the product.
5. Apply standards : Design the product in compliance with the identified standards and carry out the necessary tests.
6. Compile technical documentation : Gather all technical documents, including plans, test reports, and user manuals.
7. Draft the declaration of conformity and affix the CE marking : Finalize by drafting the declaration of conformity and affixing the CE logo to the product.
You can find more information in our article on the 7 stages of CE marking.
The various European directives for CE marking
European directives are regulations that define the essential safety, health and environmental protection requirements for different types of products. Each product subject to CE marking must comply with one or more specific directives to be legally marketed in the European Economic Area.
Why choose the appropriate guidelines?
Each directive is designed for a particular type of product or specific safety aspects. For example, the Machinery Directive applies to industrial equipment, while the Low Voltage Directive applies to electrical appliances. Choosing the right directive is crucial because it determines the harmonised standards your product must meet to be compliant. Following these directives ensures that your product is safe and ready to be placed on the European market.
Each directive has its own specific requirements and is associated with harmonised standards that facilitate the presumption of conformity. To comply with the CE marking, it is essential to correctly identify the directives applicable to your product and to follow the corresponding standards . This not only allows you to affix the CE marking, but also to guarantee the safety and reliability of your products on the European market.
Examples of Directives:
• Machinery Directive : Concerns industrial equipment and machines, guaranteeing their safety of use.
• Low Voltage Directive : Applies to electrical devices operating within a certain voltage range.
• Electromagnetic Compatibility (EMC) Directive : Covers devices likely to emit or be subject to electromagnetic interference.
• Toys Directive : Specific to toys intended for children, ensuring that they are safe to use.
• Medical Device Regulations : Implies strict compliance for medical equipment used on patients.
• Pressure Equipment Directive (PED) : Applies to tanks, boilers and other pressure equipment.
• Radio Directive : Concerns radioelectric equipment, ensuring its proper functioning and safety.
• Personal Protective Equipment (PPE) Directive : Ensures that personal protective equipment is safe for users.
There are other directives, you will find more information on the European Commission website.
Best practices to ensure CE compliance
To ensure successful certification, here are some best practices to follow:
Start integrating the regulatory aspects of CE marking into your project as early as possible
Contact the right people to help you with your CE certification
Involve your development teams in the CE process
Integrated from the start of your project the budget necessary for CE marking
Common mistakes to avoid with CE marking
The CE marking process can be complex, and some common errors can lead to delays or non-conformities.
Here are the main mistakes to avoid:
1. Neglecting to identify Directives : Failure to identify all directives applicable to your product may lead to non-compliance.
2. Underestimating the importance of documentation : An incomplete or poorly structured technical file can invalidate your CE marking.
3. Ignoring harmonized standards : Failure to follow relevant harmonized standards can make it difficult to demonstrate conformity.
4. Lack of real-world testing : Limiting testing to ideal conditions without considering real-world usage scenarios can expose security vulnerabilities.
5. Incorrect drafting of the declaration of conformity : A poorly drafted or incomplete declaration of conformity is a common cause of rejection during audits.
6. Failing to keep up with regulatory updates : Guidelines and standards evolve. Failure to keep up with these developments may render your product non-compliant in the future.
7. Failing to train the team : A team that is not trained in CE marking requirements can make costly mistakes.
8. Poor communication with suppliers : Failure to require CE compliance of components or products supplied can compromise your entire product.
By avoiding these common mistakes, you will increase your chances of successfully completing the CE marking process and ensuring that your product complies with European requirements.
How long for marking?
The time it takes to obtain the CE marking depends on several factors, including the complexity of the product and the level of preparation of the company. In general, the process can vary from a few weeks to several months. Here are the main steps that influence the duration:
Identification of Directives and Standards : A few days
Security tests : A few weeks
EMC/radio tests: 1-2 weeks
Compilation of the technical file : A few weeks
The total time can vary, but on average, expect between 1 and 6 months for a full CE marking. For more details, check out the full article here .
How much does CE certification cost?
The cost of CE certification can vary considerably depending on the nature of the product, the complexity of the process, the number of applicable directives and standards, and the services required. Here are the main elements that influence the cost:
1. Testing and Analysis : The testing required to demonstrate compliance can represent a significant portion of the budget, especially for complex or innovative products. It can cost between €1,000 and €5,000 for simple products, but can reach up to €20,000 or more for sophisticated products.
2. Technical Documentation : Preparing the technical file may require the intervention of specialists, especially if you need to integrate risk analyses, detailed plans and test reports. The costs here depend on the complexity of the product and the time required to compile it.
3. Notified Body : For certain products, it is mandatory to use a notified body to validate CE conformity. The fees of these bodies can vary between 5,000 and 100,000 euros, or even more, depending on the complexity of the assessments required.
4. Internal Time and Resources : The cost of CE certification also includes the time and internal resources dedicated to this process. This includes training your staff, managing compliance, and monitoring regulatory developments.
5. External Consultants and Services : If you hire specialist consultants to assist you with the CE marking process, this will also add to the overall costs. However, using experts can speed up the process and ensure seamless compliance.
Depending on these factors, the total cost of CE certification can vary between 5,000 and 50,000 euros , or even more for particularly complex products such as medical devices. It is crucial to properly assess these costs in advance to avoid surprises and ensure that your product will comply with European requirements.
For more specific details, you can check out the full article on the cost of CE marking here .
Conclusion
CE marking is an essential element to ensure the compliance, safety, and commercial viability of your products on the European market. By following a rigorous process and avoiding common pitfalls, you can not only meet legal requirements, but also build customer confidence and access new business opportunities.
Säfeli is here to support you throughout the CE marking process, providing you with the expertise needed to ensure the compliance of your products and succeed in the European market.
Need help with your CE marking projects? info@safeli.ch
Common questions about CE markings
What is CE marking?
The CE marking indicates that a product complies with EU safety, health and environmental requirements.
Which products require CE marking?
Products such as electrical appliances, toys, medical devices, and many others require this marking.
Is CE marking mandatory?
Yes, it is mandatory for sale in the European Economic Area (EEA) for many products.
How to obtain CE marking?
Identify applicable guidelines, follow harmonized standards, perform necessary tests, and compile a technical file.
How long does the process take?
This can take between 3 and 6 months, depending on the complexity of the product.
How much does CE certification cost?
Costs range from 5,000 to 50,000 euros, depending on testing and the complexity of the product.
What happens if I don't get the CE marking?
Sale of the product in the EEA will be prohibited, and penalties such as fines or product recalls may apply.
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