What is a CE Mark & Do You Need a CE Certification?

A CE mark allows you to sell your product in larger Europe. Manufacturers must include the CE mark on all products that fall under one of 25 European directives. It’s estimated that around 70% of all products sold in the EEA must bear a CE mark. 

Let’s take a closer look at what a CE mark is and the rules around getting one.

What Is a CE Mark?

The CE mark is an abbreviation of “Conformité Européenne,” or European conformity. The CE mark first came into existence in 1993 through the 93/68/EEC Directive. It replaced its predecessor, the EC mark, and became the new way of communicating to consumers and safety officials alike that a product is compliant with all applicable health, safety, and environmental requirements in the European Economic Area (which includes the EU and the European Free Trade Association). 

A CE mark is typically visible somewhere on the product–often alongside many other markings such as the Eurasian Conformity (EAC) and the UKCA marking. 

What Is a CE Certification and Do You Need One to Get Your CE Mark?

The idea of a “CE certification” or “CE certificate” for products sold in the EU and EFTA is

something of a misconception. That’s because there is no specific organization or governing body that grants manufacturers a CE certification, authorizes the use of the CE mark, or tests individual products for compliance with all the directives under the CE umbrella. Instead, it’s up to the company producing and distributing a given product to ensure that it follows all the requisite directives. As the Canadian government succinctly puts it, “the manufacturer, whether established inside or outside the EU, is ultimately responsible for affixing the CE mark and is also responsible for its proper use.” (CE certifications and/or CE certificates do, however, come into play if a manufacturer opts to employ the services of something called a notified body, which we’ll return to.)

It probably goes without saying, however, that companies and manufacturers must do far more than simply slap a permanent, legible marking to their products. According to the EU, they need to carry out several crucial steps before adding the CE mark. These include:

• Ensuring conformity with all EU requirements 
• Assessing your product, either yourself or by utilizing a notified body 
• Putting together a technical dossier outlining your product’s conformity
• Drafting an EU declaration of conformity

Let’s take a look at each of these measures in greater depth. 

CE Mark Requirements: Understanding the EU Directives and Conformity Assessment Modules 

At some point during the process of preparing their product or products for the EU market, manufacturers may find themselves asking, “What does the CE mark mean?” In other words, what are the guidelines or regulations that need to be adhered to before putting on the mark? 

The answer depends on the type of product a manufacturer is looking to bring to market. The CE mark essentially represents conformity to one or more of 25 directives. These directives cover the following categories (more information on product groups and specific directive numbers can be found on the European Commission website):

• Low Voltage Directive (LVD)
• Radio Equipment Directive (RED)
• Electromagnetic Compatibility (EMC)
• Machinery
• Lifts
• Noise Emissions for Outdoor Equipment 
• Pressure Equipment
• Simple Pressure Vessels 
• Medical Devices
• In Vitro Diagnostic Medical Devices
• Active Implantable Medical Devices
• Eco-design for Energy Related Products (ErP)
• Restriction of Hazardous Substances (RoHS)
• Appliances Burning Gaseous Fuels
• Hot-water Boilers
• Equipment for use in Explosive Atmospheres (ATEX)
• Toy Safety 
• Personal Protective Equipment (PPE)
• Recreational Craft
• Construction Products
• Pyrotechnic Articles 
• Explosives for Civil Uses
• Cableway Installations to Carry Persons
• Measuring Instruments
• Non-automatic Weighing Instruments 

To ensure your product conforms to all the applicable EU requirements—and thus justifies the CE marking—manufacturers must identify and adhere to all the directives that apply to their product. These directives include specific conformity assessment procedures, which are referred to as “modules.” There are a total of eight different modules that a specific directive may require manufacturers to undertake. These modules are as follows:

• Module A: Internal Production Control
• Module B: EC Type Examination 
• Module C: Conformity to Type 
• Module D: Production Quality Assurance 
• Module E: Product Quality Assurance
• Model F: Product Verification
• Model G: Unit Verification
• Model H: Full Quality Assurance 

Notified Bodies and CE Certification Meaning 

Depending on the directives you’re trying to follow, you may need your products assessed for conformity. Certain directives explicitly require manufacturers to use a notified body for conformity assessments. These directives include those for:

• Medical devices
• Equipment for use in explosive atmospheres
• Pressure equipment
• Appliances burning gaseous fuels
• Simple pressure vessels  

To do this, companies must coordinate with the aforementioned “notified body.” A notified body is a designation given to organizations by their EU country that grants them the authority to assess the conformity of specific products. These organizations carry out CE mark testing in accordance with the relevant directives to ensure that their client’s product is in full compliance with EU regulations. When their work is completed, they will typically issue a CE certificate to their client, allowing them to move forward in the process of achieving conformity and affixing the CE mark. CE certificate meaning, in other words, is simply the documentation provided by a notified body demonstrating adherence to all applicable EU directives. 

Manufacturers that cannot carry out the requisite conformity assessment on their own must use one of these designated organizations. The European Commission keeps a list of these bodies through their New Approach Notified and Designated Organisations (NANDO) Information System. 

What Is a Technical Dossier and How Does It Relate to CE Mark Approval? 

Manufacturers bringing a product to the EU market must also put together specific technical documentation outlining details and manufacturing processes related to the product and 

demonstrating that a conformity assessment has been executed. This technical dossier is legally required for companies to move forward with putting the CE mark on their products, and must be readily available to enforcement authorities should they request it. Companies typically put together their dossiers after successfully carrying out conformity assessments, but before they draft a declaration of conformity. 

The dossier should include:

• A description of the product
• Address and contact information for the facilities where the product was designed and manufactured
• Information related to any notified bodies involved in the conformity assessment process
• The declaration of conformity

In addition, manufacturers should carry out a comprehensive risk assessment of their product to determine all the potential risks it poses to consumers. You’ll want to consult the EU website for detailed instructions on compiling a technical dossier for your CE mark. 

Finally, the technical dossier should be made accessible to the relevant national authorities by the time the product is released into the market, and it should be readily available for at least 10 years after the product is introduced. 

Declaration of Conformity (DoC), the Final CE Mark Requirement 

The declaration of conformity is the final step en route to actually affixing the CE marking on your product. And if there’s one relatively easy, straightforward part of this process, this is it. Manufacturers or their authorized representatives must draft and sign a DoC declaring that their product adheres to all the applicable EU regulations, and specifying which directives it is compliant with. The DoC is a way for the manufacturer to essentially state that they assume complete responsibility for their product’s adherence to the law. 

Determining Whether You Need a CE Mark

Unfortunately, there is no database or inventory that companies can consult to definitively determine whether their product requires the CE mark. Rather, they must carefully review the 20-plus directives and independently decide which directives apply to them. (It’s important to remember that the majority of products in the EU market fall under at least one of the directives, and therefore require the steps that go into the CE marking.)

A compliance solutions firm or trade commissioner can help you discern which directives, if any, apply to your product. 

Consequences for Illegally Adding a CE Mark

Companies that affix the CE mark to their products without carrying out the mandatory measures, or that simply do not affix the CE mark at all, are breaking the law. These businesses face several consequences. The national authorities will restrict the product in question from reaching the market, or, depending on the specific circumstances, execute a full-scale recall from market. Additionally, companies and manufacturers found to be in violation of the CE marking requirements are subject to fines and even imprisonment (penalties vary between member countries). France, for example, imposes penalties of up to 37,500 euros and the possibility of prison time. 

Common Mistakes and Misconceptions Around the CE Mark

There are a number of relatively common misunderstandings related to the CE mark and the process companies must go through before applying it to their products. The first and arguably the most prevalent—which was alluded to earlier—is the notion that manufacturers must obtain a CE certification or CE certificate from an official government body or regulatory agency that enforces the European directives and grants companies CE mark approval. The reality is that companies seeking to bring a product to the EU market must ensure the compliance of that product themselves, either via an in-house assessment or by using a notified body (who then issues a CE certificate). 

A second common misconception is that because each of the 25 or so directives represents a specific product category, you’ll only be responsible for fulfilling a single directive (i.e., the category your product falls into). While this may be a reasonable conclusion in some or even most cases, there are certain products that are affected by multiple directives. In these instances, manufacturers may have to carry out multiple conformity assessments to ensure legal compliance. Because there is no reference guide or online tool that can tell you exactly which directives impact your product, though, some manufacturers choose to use a professional firm to help them achieve CE compliance. 

What Your CE Marking Should Look Like 

Once a company has fulfilled all the requirements, they can actually carry out the process of affixing the CE marking (or the CE mark label). According to the EU, there are several specific CE mark requirements. First, the marking must be visible, legible, and indelible. In addition, both letters should have the same vertical dimension, and cannot be smaller than 5mm. In cases where the marking cannot be affixed to the product—for example, if it is too small to fulfill the size requirements—it can be applied to product packaging or related documentation. 

Businesses looking to bring a product or products to any of the 30 countries in the EU and EFTA should treat the CE marking and everything the CE mark label represents with careful attention, diligence, and a sense of thorough, even painstaking precision. Whether you’re introducing a medical device, a forklift, or a new toy, executing the measures required to earn the CE marking demonstrates a level of safety, rigor, and preparation that will assure both consumers and government officials of the quality of your product.