

The CE marking is not a seal of quality. What it is and how to get the "EU Declaration of Conformity".
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The CE marking, which can be found on many products, should not be mistakenly understood as an individual seal of quality. In fact, it is a declaration by the manufacturer certifying the conformity of the respective product with the applicable EU harmonization legislation and the applied technical standards.
The issue of an EU Declaration of Conformity goes hand in hand with the CE marking on the type plate. Conversely, a CE marking on a nameplate makes clear that there is an EU Declaration of Conformity for this product.
Its main purpose is to ensure that products placed on the free market within the EU comply with the essential requirements. For this reason, the CE marking is often regarded as a kind of "passport" for the European single market. The relevant EU harmonization legislation (e.g. EU directives and regulations), for example, lays down minimum health and safety requirements for a wide range of products, which must be strictly adhered to.
In order for a product to be legally marketed and used, it must undergo a conformity assessment procedure as prescribed in the EU harmonization legislation.
This procedure is not only found within the EU, but also in other regions of the world.
It is not only the visual implementation of the CE marking on the products and type plates themselves that harbors potential for error. People also often mistakenly ask "who" is allowed to issue the CE marking in the first place. Below is a compact compilation of frequently asked questions about the CE marking and their answers.
Actually, the question should be: Who is allowed to affix CE? As a rule, the manufacturer himself is responsible for the conformity of his product with the applicable EU directives or regulations and for affixing the CE marking. However, the manufacturer can also appoint an authorized representative within the EU who fulfils the conformity requirements on behalf of the manufacturer.
There are some important points to note here:
Manufacturer within the EU: if the manufacturer is based within the EU, he is responsible for the conformity of the product and may affix the CE marking himself.
Manufacturers outside the EU: If the manufacturer is based outside the EU, he must generally appoint an authorized representative within the EU to monitor the conformity requirements and affix the CE marking on behalf of the manufacturer.
CE marking is the responsibility of the manufacturer: The affixing of the CE marking and the associated conformity assessment are the responsibility of the manufacturer. This means that the manufacturer must ensure that the product complies with the applicable EU directives or regulations and carry out the necessary conformity assessment steps.
Conformity assessment by third parties: In some cases, it may be necessary for a Notified Body or an accredited testing body to involve third parties in the conformity assessment of the product. These bodies can carry out tests and issue certificates that are used by the manufacturer to support the CE marking.
A labeling obligation exists if the product is subject to the relevant EU regulations that require CE marking. This is the case for a wide range of products such as electronic devices, toys, medical devices, construction products, pressure vessels, machinery and industrial equipment and many more.
Yes, a declaration of conformity is mandatory in the European Union (EU) when a manufacturer places a product with a CE marking on the market. The declaration of conformity is an important document issued by the manufacturer or its authorized representative. In the declaration of conformity, the manufacturer officially declares that his product complies with the applicable EU directives or regulations.
Note: In special cases, other declarations must be issued instead of the EU declaration of conformity, e.g. an EU declaration of incorporation (for partly completed machinery) or a declaration of performance (for construction products).
There are many different CE directives that are specifically tailored to different product categories and requirements. Here are some of the most important CE directives:
1. machinery directive (2006/42/EC)
2. low voltage directive (2014/35/EU)
3. the EMC Directive (2014/30/EU)
4. medical devices directive (93/42/EEC)
5 Construction Products Regulation (EU) No. 305/2011
6. toy directive (2009/48/EC)
7. pressure equipment directive (2014/68/EU)
8 Personal Protective Equipment (PPE) Directive (89/686/EEC)
9 Lifts Directive (2014/33/EU)
10. ecodesign directive (2009/125/EC)
It is important for manufacturers to identify the specific directives that apply to their products and ensure that the respective products meet the relevant requirements before affixing the CE marking and placing them on the European market.
Liability for products without CE marking may vary depending on the circumstances and applicable laws. In general, the following parties are potentially responsible for liability:
It is important to note that the exact liability regime may depend on the applicable laws and circumstances.
The CE marking is checked by various bodies and authorities in the member states of the European Union (EU). These bodies have the task of ensuring that products bearing the CE marking actually comply with the applicable EU directives or regulations and thus meet the requirements for health, safety and environmental protection. Here are some important aspects of CE marking control:
Checks can take the form of spot checks, reviews of product documentation, inspections of manufacturers and distributors and other surveillance measures. If a product bearing a CE marking does not comply with the applicable regulations, action may be taken to withdraw the product from the market, impose fines or take other legal action.
It is important to emphasize that compliance with CE marking requirements is crucial to ensure the safety of products in the EU.
In the European Union (EU), products that fall under the CE marking obligation may not be sold without the CE marking. The CE marking is an important indication that a product complies with the applicable EU directives or regulations aimed at health, safety and environmental protection. The absence of a CE marking may indicate that the product does not meet the required standards and therefore may not be safe.
Various documents and steps are required for the CE marking of products in the European Union (EU). The exact requirements may vary depending on the product type and the applicable EU directives, but in general the following documents are required:
1. technical documentation
2. risk assessment
3. test reports and certificates, if applicable
4. operating instructions
5. documentation for quality assurance
6. declaration of conformity
7. labeling
8. EU authorized representative, if applicable
It is important to note that the requirements may vary depending on the product and EU regulations. It is necessary to familiarize yourself with the specific EU regulations that apply to a particular product.
Status 12/2023
This overview serves as an aid for product compliance managers, CE officers or other persons involved. The 10-step plan is primarily related to the European domestic market, but could easily be adapted to global distribution.
IDENTIFY HARMONIZATION LEGISLATION AND OTHER AREAS OF LAW
ANALYZE SCOPE OF APPLICATION WITH DEFINITIONS
DETERMINE THE CONDITIONS FOR PLACING ON THE MARKET
IDENTIFY BASIC REQUIREMENTS FOR THE PRODUCT AND CARRY OUT A RISK ASSESSMENT
RESEARCH AND MONITOR STANDARDS
APPLY CONFORMITY ASSESSMENT PROCEDURES
COMPILE TECHNICAL DOCUMENTS
COMPILE EXTERNAL USER INFORMATION
ISSUE AND SIGN DECLARATIONS
AFFIX CE LABELING
Benjamin Kerger (B. Eng.)
Product Compliance Consultant and certified Product Compliance Officer according to ISO/IEC 17024
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Glossary
The abbreviation CE represents the French term "Conformité Européenne", which means "European Conformity". The CE symbol indicates the conformity of the product with the requirements imposed on the manufacturer by the European Community.
By affixing the CE marking, the manufacturer, the distributor or the EU authorized representative declares that the product complies with the requirements set out in the Community harmonization legislation. At the same time, they assume responsibility for compliance with all relevant provisions for affixing the CE marking in accordance with Community harmonization legislation.
A technical data label, sometimes referred to as a manufacturer's label or product label, is an information plate affixed to an object by a manufacturer or responsible importer. This plate contains identifying, descriptive and classifying information that often complies with legal regulations, the requirements of regulatory authorities or industry standards.
The declaration of conformity is a written document that is issued at the end of a conformity assessment. In this declaration, the responsible party (e.g. manufacturer, distributor, operator or entrepreneur) undertakes with regard to a product, the provision of a service or an organization (such as a testing laboratory or an operator of a quality management system). It bindingly confirms that the object in question (be it a product, a service, a site or a quality management system) fulfills the specified characteristics as listed in the declaration.