FINALLY Understanding CE marking

The CE marking is not a seal of quality. What it is and how to get the "EU Declaration of Conformity".



→ FREQUENT QUESTIONS
→ 10 STEPS TO CE MARKING
→ FROM PRACTICE
→ REGULATORY ESSENTIALS & ONLINE FINDER

← BACK

 

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.

FREQUENTLY ASKED QUESTIONS

ANSWERS AT A GLANCE

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.

Who is authorized to issue CE?

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.

Which products require 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.

Is a declaration of conformity mandatory?

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).

What CE directives are there?

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.

Who is liable if products do not have a CE mark?

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:

  1. Manufacturer: the manufacturer of the product usually bears the primary responsibility for the conformity and safety of the product. If a product is sold without CE marking and this is due to the manufacturer's failure or negligence, the manufacturer may be held legally liable. This can lead to legal action, claims for damages and penalties.
  2. Importer: If a product is imported into the EU from a non-EU country and it does not bear a CE marking, the importer can be held liable. The importer is responsible for ensuring that imported products comply with EU requirements and are properly labeled.
  3. Distributors and dealers: Dealers who sell products without CE marking can also be held legally responsible, especially if they were aware or should reasonably have been aware of the lack of CE marking. This can lead to sanctions and legal consequences.
  4. Consumers: If a consumer buys a product without CE marking and this product causes damage or injury, the consumer can take legal action against the manufacturer, importer or distributor and claim compensation.

It is important to note that the exact liability regime may depend on the applicable laws and circumstances.

Who checks the CE marking?

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:

  1. National market surveillance authorities: Each EU member state has its own national market surveillance authorities. These authorities are responsible for monitoring and enforcing CE marking regulations in their respective countries. They carry out random checks, receive complaints and can impose sanctions on manufacturers who do not comply with the regulations.
  2. Notified bodies (formerly known as "Notified Bodies" in German): In some cases, the conformity of products must be assessed by Notified Bodies before they can be CE marked. These Notified Bodies are independent certification bodies that are often directly affiliated to a testing body.
  3. European Commission: The European Commission plays a role in monitoring and enforcing CE marking regulations at EU level. It supports the Member States in coordinating controls and can take action in the event of serious or repeated infringements of the regulations.
  4. Consumers and competitors: Consumers and especially competitors help to monitor compliance with CE marking requirements by reporting suspicious products or submitting complaints.

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.

Can I sell products without a CE mark?

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.

What documents are required for CE marking?

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

Roadmap for the European Single Market

 

10 steps to CE marking

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

EXAMPLE FROM PRACTICE


Benjamin Kerger (B. Eng.)
Product Compliance Consultant and certified Product Compliance Officer according to ISO/IEC 17024



"Even excellent machine builders with experience in product conformity suddenly face major challenges when they network their machines. This is because, in addition to the familiar Machinery Directive, there is a considerable amount of new harmonization legislation that must be observed.

In fact, with the information from our Regulatory ESSENTIALs on the topic of cybersecurity, we can provide much more certainty. The responsible persons are to quickly find their way around the new regulations and derive measures for implementation, without the need for a lengthy internet research. The NIS 2 Directive, the new Machinery Directive, the forthcoming Cyber Resilience Act and the IT security requirements within the Radio Equipment Directive are just a few examples."
 

Your challenges

Do you lack up-to-date information on the regulatory requirements of your international target markets?

Do you have not enough time and human resources to acquire this important knowledge?

Are you really able to assess whether the information you have researched comes from official sources and is up to date or not?

YOUR SOLUTION


Regulatory Essentials

Modular information packages with essential information for compliant products in your target markets, incl:

  • An analysis of the regulatory requirements
  • Identification of the responsibilities of the relevant economic operators
  • Essential information on market access conditions
  • A list of labeling and documentation obligations
  • The "Route to Compliance" guide

Accessible online at any time on the ROGER WILLCO product compliance portal.
 

Your advantages

Immense time saving

Valuable know-how development

Current and correct information

Know what to do!

Combine subject areas and target markets for your products now and find out which Regulatory ESSENTIALS will help you!



DO YOU HAVE ANY QUESTIONS?

Our Regulatory ESSENTIALS team will be happy to help you:

Phone: +49 30 3229027-50
Email: essentials@globalnorm.de


 

REGULATORY ESSENTIALS
ACHIEVING COMPLIANT PRODUCTS MORE EASILY AND QUICKLY

 

Over 18 subject areas

 

Accessible online

 

More than 29 countries and economic areas

 

Regularly updated

 

 

More about the Regulatory ESSENTIALS

Benefit from MORE THAN 300 INFORMATION PACKAGES


Combine the legal areas and target markets relevant to you and create a knowledge database for your globally compliant product portfolio!

Subject areas:

 

Electromagnetic
Compatibility


Hazardous substances (RoHS)
 


Food contact
materials


Ecodesign & energy consumption

General chemical requirements (REACH)


Explosion protection (ATEX)


In Vitro Diagnostics


Machine safety/protection


X-ray radiation

Cybersecurity


Fluid systems and components


Critical infrastructure


Medical devices

Electrical safety


Radio equipment


Laser requirements


Metrology and metrology

Countries and economic areas:

European Economic Area


SOWIE

EGYPT

China

HONGKONG

Canada

MALAYSIA

Switzerland

Thailand

UNITED ARAB EMIRATES

Australia

Eurasian economic area

India

Kazakhstan

MEXICO

Singapore

Turkey

UNITED KINGDOM

Brazil

European Economic Area

ISRAEL

Qatar

New Zealand

South Africa

UGANDA

CHILE

Gulf Cooperation Council

Japan

SOUTH KOREA

Saudi Arabia

TAIWAN

USA

Accessible online from anywhere:

You can conveniently read the Regulatory ESSENTIALS information online in the ROGER WILLCO product compliance portal.

  • Information compiled by experts on the market approval requirements in your target markets (in English)
     
  • Essential knowledge on requirements in the areas of electrical safety, radio, electromagnetic compatibility (EMC), hazardous substances (RoHS), explosion protection (ATEX), machine safety, etc.
     
  • Detailed information on the products covered and the approval procedures in accordance with the applicable legislation
     
  • Direct links to the applicable legislation and, where applicable, official interpretation aids
     
  • Helpful tips from our experts on understanding any associated requirements and more

 

 

Combine the subject areas and target markets relevant to your products in our online finder and get an overview of the appropriate Regulatory ESSENTIALS!

MAKE AN INQUIRY

REGULATORY ESSENTIAL ONLINE FINDER & CONSULTING

Do you want to find out specifically which subject areas and target markets you can use Regulatory ESSENTIALS for?
You can obtain non-binding advice online here in just 3 simple steps and then send us an inquiry:
 

Which topics are relevant for your company's products?

Which statements apply to your product?

Which target markets are relevant for the distribution of your products?

Your personal data will be processed by GLOBALNORM.
You can find further information in our privacy policy.

Back
THE EXPERTS BEHIND THE REGULATORY ESSENTIALS

All information is compiled by a team of experienced product and material compliance experts. It contains only relevant, up-to-date and verified information in English and is checked and updated at regular intervals.

Dipl.-Ing. (FH)
Michael Loerzer

Regulatory Affairs Specialist

B.A.
Linda Kritzler
Material & Environmental Compliance Consultant

Fully qualified lawyer
Inken Green
Product & Material Compliance Expert

B. Eng.
Benjamin Kerger

Product Compliance Expert (EMC, radio, safety)

Dipl.-Ing. (FH)
Torsten Sahm

Product Compliance Expert (EMC, radio, automotive)

Dipl.-Ing. (FH)
Anette Dunkel-Reinboth

Regulatory Analyst

 

Glossary

 

CE

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.

CE marking

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.

Type plate

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.

Declaration of conformity

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.

Login
x

In accordance with the EU ePrivacy (Cookie) Directive (2009/136/EG), we would like to inform you that our website uses cookies. By using our website, you accept and agree to our Privacy policy. Please view our Privacy policy to find out what cookies we use and how to disable them.

OK