The Electromagnetic Compatibility Directive (EMCD)
The Electromagnetic Compatibility Directive 2014/30/EU – A guide for manufacturers and importers that sell and market electrical products on the EU market. This article is
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CE marking is a mandatory product marking for goods sold within the European Economic Area (EEA).
At Certify & Comply, we have written this guide on CE marking to assist manufacturers and importers in navigating the process of CE marking their products.
CE marking is a mandatory product marking for goods sold within the European Economic Area (EEA). The marking indicates that a product meets the health, safety, and environmental protection requirements outlined in EU directives and regulations. The CE marking serves as visible proof that the product complies with EU legislation and can circulate freely in the European market.
At Certify & Comply, we have created this guide to help manufacturers and importers navigate the process of CE marking their products.
This article aims to answer questions such as:
When discussing product compliance in the EU market, it almost always revolves around CE marking. This highlights a common misconception about what CE marking signifies. It also demonstrates how effective the iconic marking, present on so many products, is in introducing the European population to the concept of product compliance.
The CE mark, or Conformité Européenne mark (European Conformity in French), is a product marking established by the European Commission. CE marking is often interpreted as an assurance of product safety and quality, but in reality, it is more nuanced. Read on, and we will explain what we mean.
CE marking is required for products that fall under a CE marking directive that mandates the CE mark.
To put CE marking in its proper context, it is important to understand the legal framework that defines the requirements for products, both those within and outside the scope of CE marking.
Product requirements are defined in EU directives and regulations. Each piece of legislation (legislation will be used as a collective term for directives and regulations) defines the scope of products it covers. For each product that falls within the scope, various requirements are outlined. Within a number of these legislations, the requirement for CE marking is specified, such as the regulation on personal protective equipment (PPER – (EU) 2016/425) and the directive on toy safety (TSD – 2009/48/EC).
The legislation is designed so that every product intended for consumers is covered by at least one piece of legislation. Essentially, this means that all products must consider these legislations, and no goods intended for consumer use in the EU market can be considered outside the scope of EU legislation.
The CE mark means that the manufacturer assumes responsibility for assessing that the product is legally compliant.
In the aforementioned legislations, CE marking is defined as a marking through which the manufacturer indicates that the product complies with the applicable requirements in the union’s relevant harmonization legislations that require CE marking. The interpretation of this should focus on the following:
This shows that CE marking is not proof that a product is safe for consumers and other end users. Instead, it only indicates that the manufacturer takes responsibility for certain aspects of product safety. This responsibility is formalized in certain declarations, which will be further explained in the CE marking process.
CE marking and the process required beforehand must always be carried out by the person or company that places their name or brand on the product.
As stated above, it is solely the manufacturer’s responsibility to correctly CE mark their products. But who is the manufacturer?
Sometimes the answer is simple. When the same company designs, manufactures, and sells a product, there are rarely any questions about who is responsible.
However, when a company purchases a finished product to then brand it with its own trademark, it may be less clear who is responsible. The legislation states that it is always the one who places their name or brand on a product who is fully responsible for the product and its CE marking.
The definition of a “manufacturer” is defined in official documents as:
“Manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under their name or trademark.”
One of the most important aspects of CE marking and other parts of the “Union’s harmonized legislation” is the concept of “presumption of conformity.” This concept applies to several different areas. In the case of CE marking, authorities and customs are to assume that products bearing the CE mark meet the necessary requirements unless proven otherwise. This grants CE-marked products free movement across the entire EU market, known as the European Economic Area (EEA).
This makes it crucial to ensure that the “formal” product compliance (such as marking) is correct to avoid issues. For example, customs authorities primarily look for formal errors, such as incorrect proportions of the CE marking, the CE marking being too small, or the product not being labeled with the manufacturer’s contact details.
From the perspective of manufacturers and sometimes other economic operators, the whole system is often viewed through the lens of “how do we CE mark our product?” or something similar. While this is a good place to start, it can be somewhat misleading. First, not all products qualify for CE marking, and second, CE marking is just one part of a broader system of product compliance.
A more comprehensive question would be: “How do we achieve product compliance in the EU market?”
Let’s show some examples of legislation that applies to CE-marked products, non-CE-marked products, or both.
As previously mentioned, CE marking applies to products that fall under specific legislation (these are commonly referred to as CE legislation, CE directives, or similar). The European Commission provides a list of these laws on their website; they refer to them as product groups. This is a valuable resource for manufacturers to understand which legislation requires CE marking that may apply to their products. For most, it also contains a summary of the aspects of the legislation that the manufacturer needs to be most aware of.
Let’s show some examples of products that can easily be identified within the legislation and others that are more misleading.
Sunglasses
Sunglasses can be easily identified under personal protective equipment as they protect against sunlight. Therefore, they must be CE-marked.
Toilets
Toilets fall under the scope of construction products. Therefore, toilets should be CE-marked.
Water Taps/Mixers
These fall under the scope of construction products. However, these do not need to be CE-marked due to certain complexities in the Construction Products Regulation (CPR). Construction products are the only product group that sometimes has the option of CE marking; read more about construction products in our article on CPR.
Height-adjustable aesks (with electric motors)
Electrical products have a handful of legislation that may apply. This product falls under the scope of:
When the Machinery Directive applies to a product, it replaces the Low Voltage Directive. Therefore, the Low Voltage Directive is not applicable even if the product falls within its scope. The product must be CE-marked.
The list above is not exhaustive, but It demonstrates that determining whether a product requires CE marking can sometimes be simple and other times more complex.
It also shows that determining which legislation a product should be CE marked under is not always straightforward, even when it’s clear that the product must be CE marked.
We assist with CE marking in areas such as product safety, machinery safety, medical devices, and construction products.
So, what happens if your product doesn’t fall under any legislation that requires CE marking? Perhaps your company has designed a completely new product that falls outside the scope of all CE legislation.
The European Commission has introduced a simple solution for these cases: the General Product Safety Directive (GPSD) 2001/95/EC. The GPSD regulates product safety for all products but is mainly relevant for products not covered by specific product legislation. It is somewhat vague regarding specific requirements to be as broadly applicable as possible.
In its purest form, the GPSD requires that manufacturers primarily “shall be obliged to place only safe products on the market.” Aside from certain requirements for labeling and user instructions, the GPSD does not specify how a product should be deemed safe. This has generally been interpreted as requiring that technical documentation be available to prove that the manufacturer has considered safety during the product’s design phase. This effectively imposes similar requirements on general products as on CE-marked products; the technical documentation will be further explained below.
Here are some examples of products that rely on GPSD for their safety requirements and are not eligible for CE marking:
So, the GPSD and CE legislation cover product safety for compliance in the EU, but this is far from the only part of the system. There is a wide range of legislation that imposes restrictions on substances, labeling requirements, waste management responsibilities, and more.
These affect products whether they are CE marked or not, so a correctly placed CE marking does not indicate that the product meets all requirements within the EU market.
We discuss these legislations by sorting them into broad categories; here are two examples that are almost always applicable:
Substance and chemical restrictions
For products on the EU market, two main regulations impose restrictions on substances and chemicals for all products:
Together, these two regulations define over 300 substances that are either not allowed or only permitted in specific concentrations. Violating these restrictions is considered a serious offense, and all manufacturers should be aware of and take into account these substances. Unfortunately, the presence of these substances is often unknown, especially for materials and components manufactured outside the EU.
Producer responsibility
As a measure to combat the amount of waste produced within the EU, producer responsibility has been implemented among various waste laws. These require that the manufacturer/producer of certain products and materials must comply with national collection systems. Common examples of these are:
When these directives describe producer responsibility, they do not always refer to the manufacturer. Most often, it refers to the party that introduces the product/material to the national market or someone who uses the material commercially. The PPWD is likely applicable to more than 99% of consumer products on the market.
You can find the “6 Steps to Affix a CE Marking to Your Product” on official websites about CE marking, for example, here.
These steps are:
However, as the Commission points out, the steps may vary depending on the specific product, so this should not be interpreted as a comprehensive guide for all products. In reality, the process is rarely as linear as this, but all these steps must be included. (For instance, we simplify this into three steps. Read all about our three-step compliance process here.)
Below is a general overview of what is required before CE marking a product; this is not necessarily a description of the process itself. If you prefer to read about the cost of CE marking, you can read about it here.
Identify all product requirements
Before a manufacturer can prove their product’s compliance, they must know what the product must meet. The 6 steps identify EU directives (and regulations), harmonized standards, product-specific requirements, and possibly the need for a notified body. The 3 steps can be summarized as product requirements.
The most challenging part is often correctly identifying all EU directives/regulations and harmonized standards. All directives can be found on the Commission’s website, but this can be quite time-consuming if you’ve never read them before. We have summaries of some of them on our website.
Technical documentation and declaration
With the requirements identified, the manufacturer must assess and document that the product complies with them. This can include testing, documenting product design, and more. The ultimate goal is to have documentation that shows (and how!) the product meets the requirements.
This is called technical documentation or a technical file and is included in one way or another in all CE laws.
This documentation should be created as the product is developed. By continuously working on the documentation, you can keep track of which requirements have not yet been met or documented.
EC declaration of conformity
When the manufacturer believes that the technical documentation is sufficient to prove compliance with all applicable CE legislation, they must draft a Declaration of Conformity (DoC). This DoC is a legally binding document in which the manufacturer takes full responsibility for the product’s compliance with all applicable CE legislation.
This document acts somewhat as a summary of the product’s technical documentation. With it, authorities can quickly get an overview of a product’s claimed compliance with relevant legislation, so it’s an important document to get right!
Construction products are the only CE-marked products that do not use an EC Declaration but instead a Declaration of Performance. Read more about why the CE marking for construction products works differently from the usual CE process here.
Only after the DoC has been prepared and signed can the product be CE marked and legally placed on the market. In this way, the CE marking indicates to consumers and authorities that the previous steps have been completed.
The CE marking must consist of the initials “CE”; both letters must have the same vertical dimension and be no less than 5 mm (unless otherwise specified in relevant legislation). Downloadable files for the CE mark are available on the Commission’s website; these must be used without modification or distortion to ensure the mark has the correct dimensions.
Once the product has been placed on the market, the manufacturer’s obligations are not yet over.
The manufacturer must ensure that the technical documentation and DoC are preserved for the period specified in CE legislation, usually 10 years after the last unit has been placed on the market. During this period, the manufacturer must provide these documents to authorities upon request.
Additionally, if the manufacturer believes that a product they have placed on the market does not comply with relevant legislation, they must take corrective measures.
For further reading, we have compiled answers to frequently asked questions about CE marking here. If you need help with the CE marking process, we can assist you; do not hesitate to contact us to learn more.
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