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CE Marking

CE Marking

CE Mark, CE Marking, CE Certification, How to obtain CE Marking?, What is EC Declaration of Conformity?, What does EU Declaration of Conformity (DoC) mean?, What is CE Marking?

CGS TEST SERVICES has been authorized by the European Commission as a Notified Body with the ID number 2891 to perform CE marking conformity assessment services. CGS TEST SERVICES Notified Body scope of authorization can be found on the official website of the European Union . 

We offer our expertise to our companies with the assurance of accreditation in CE Certification processes, having  TS EN ISO 17065  Product Certification and  TS EN ISO 17025  Laboratory Accreditations by the Notified Body CGS TEST SERVICES, the Turkish Accreditation Agency .

Our Main Product Service Scope in CE Marking:

  • Machines
  • Lighting Fixtures
  • Consumer Electronics
  • IT Devices
  • Electrical Devices Used in Houses and Similar Places
  • Environmental Tests
  • IP Tests

We see CE letters on almost every device and product we use, from the computer we use in our daily lives to our child’s toys. So what does this CE mark mean?

Hemen Başvur

What is the Meaning of the Letters CE?

The letters CE are the abbreviation of the word ‘Conformite European’, its English equivalent means European Conformity.

CE Mark has been put into use by the European Union with the aim of facilitating trade between countries. Before CE Certificate, each country determined product safety standards according to their own different regulations, in this case, it was a serious obstacle in front of trade. CE Certificate makes a serious contribution to facilitating trade in Europe and Turkey.

CE Certificate is the product passport used in the European market with a different perspective.

What is CE Mark?

CE Certificate / CE Mark is a sign that declares that the products comply with the minimum level of safety, health and environmental protection regulations. It should not be seen as an element of quality, its compliance appears as a legal obligation.

The most basic security level starts with CE Certificate/Mark, we should not confuse CE Certificate with approvals such as TSE, UL, CSA, VDE. The first condition for a product to be put on the market is the CE Certificate, which shows the minimum security level.

Which Products Should Have CE Mark?

Products that must bear the CE Mark have been determined by the relevant directives. A product can fall within the scope of one directive as well as more than one directive. In this case, the manufacturer/importer or distributor should definitely do a good research on the product.

In summary, within the scope of CE Marking:

  • Construction Materials
  • Elevators
  • Gas Burning Appliances
  • Hot Water Boilers
  • Pressure Vessels
  • Toys
  • Personal Protective Equipment
  • Machines
  • Medical Devices
  • In Vitro Medical Diagnostic Devices
  • Measurement Tools
  • Non-Automatic Weighing Instruments
  • Low Voltage Devices
  • Electromagnetic Compatibility
  • Simple Pressure Vessels
  • Active Implantable Medical Devices
  • Equipment Used in Explosive Environments
  • Explosives for Civilian Use
  • Vehicles Moving on Cable for Passenger Carriage
  • Recreational Boats
  • Radio and Telecommunications Terminal Devices

How to Obtain CE Certificate/Mark in Brief?

  1. Applicable Product Regulations are determined.
  2. Applicable harmonized standards are determined within the scope of regulations.
  3. Relevant tests, inspections and reports are made within the scope of the standards.
  4. Technical File is prepared.
  5. The EC Declaration of Conformity is drawn up and signed.
  6. The CE Mark is placed in accordance with the instructions.

In order to properly manage the CE Certificate/Mark process, we must seek answers to the following questions throughout the process:

  • Is my product covered by the CE Mark?
  • What are the applicable directives?
  • Is there a Harmonized Standard related to the product?
  • Does my product comply with the Standards? How will I detect this eligibility?
  • How to create a Technical File?
  • Is the EC Declaration of Conformity drawn up correctly?

How to Obtain CE Mark?

Many products require a CE Certificate before being sold in the European Union and Turkey. CE Certificate proves that your product has been evaluated and meets EU safety, health and environmental protection requirements. CE Certificate is required if it is to be sold in this market whether it is produced in Europe or Turkey.

CE Certificate is only valid for products covered by EU Regulations.

To affix the CE marking to your product, you must put together a technical file proving that your product meets all EU-wide requirements. As the manufacturer of the product, you are responsible for declaring compliance with all requirements. After your product bears the CE mark, you may need to provide all supporting documents regarding CE marking to distributors and/or importers.

Identify EU requirements for your product; EU-wide requirements are set out, for example, in directives covering different products or product sectors.

Example Regulations:

  • Toy
  • Electrical equipment
  • Machines
  • Medical devices
  • Elevators
  • Personal protective equipment

These directives set out the basic requirements that products must fulfill.

Check that your product meets specific requirements; It is your responsibility to ensure that your product meets all EU legal requirements. If harmonized EU standards are available for your product, your products must comply.
Check if your product needs to be tested by the Notified Body; For some products, specific conformity assessment bodies (‘Notified Bodies’) must verify that your product meets the specific technical requirements. This is not mandatory for all products. Use the “Nando” database to determine which Notified Body to contact.
Test your product; If your product does not need to be verified by an independent organization, it is up to you to check the product’s compliance with technical requirements. This includes estimating and documenting potential risks when using your product. Working with a 3rd party independent laboratory organization would be the best method.
Prepare the technical file; Your technical file should contain all documents proving that your product complies with the technical requirements.
Affix the CE marking and prepare the EC declaration of Conformity; Finally, you can affix the CE mark to your product. Marking must be legible and indelible. If you were subject to a notified body in step 3, you must also put that body’s identification number on the product. You must also prepare and sign an EU declaration of conformity stating that your product meets all legal requirements.

Importers

While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers must ensure that the products they place on the market comply with applicable requirements and do not pose a risk to the European public. The importer has to verify that the non-EU manufacturer has taken the necessary steps and documents are available upon request.

Distributors

Distributors need to have a basic understanding of legal requirements, such as which products must bear the CE mark and accompanying documentation, and clearly identify non-compliant products. They must also be able to demonstrate to national authorities that they have acted with care and that the manufacturer or importer has confirmed that the necessary measures have been taken. Furthermore, a distributor should be able to assist national authorities in their efforts to obtain the required documentation.

In Which Countries Is CE Mark Required?

The CE Certificate/Mark is legally required to place a product on the market in the countries shown on the map below. For example, a product was produced in China, but it is desired to be sold in Europe, in this case, the product must bear the CE Mark. However, this marking is not mandatory when a product manufactured in China is intended to be sold in China.

For many products, the CE Certificate/Mark is in the form of a self-declaration, that is, the CE Certificate/Mark is not obtained from any 3rd organization. If the manufacturer/importer or distributor does not have sufficient information from the 3rd party for the CE Certificate/mark, he/she can get consultancy service.

The process of CE Certificate/Mark is simply shown in the graphic below.

Hemen Başvur Butonu

CE Technical File

All CE marking directives require a technical documentation that proves that the products have CE Certificate.

In short, the Technical File is a collective arrangement of all kinds of documents that will prove the product’s CE Certificate.

The Technical File must contain all the information necessary to demonstrate the conformity of the product with the applicable requirements. The Technical File must be available as soon as the product enters the European market, regardless of geographical origin. Typically, the Technical File should be kept for at least ten years from the last production date of the product. Some directives expressly specify any other period (5 years in the Medical Devices Directive and Active Implantable Medical Devices Directive and 3 years in the Directive regarding energy efficiency in domestic refrigerators and freezers). This is the manufacturer’s responsibility.

The Technical File should be kept up to date, and if there are new processes applied for the product after the CE Certificate is obtained, it should be added to the file.

The Technical File should always be available and kept for at least 10 years.

Although the content and titles of the Technical File vary according to the relevant directives, it should generally be as follows;

  • EC Declaration of Conformity
  • Information about the manufacturer
  • Information and technical information about the product
  • Use and maintenance manual
  • Electrical drawings
  • Technical drawings
  • Product information and warning labels
  • List of applicable regulations and standards
  • Test reports
  • Product specific risk analysis list
  • Appropriate documents and certificates of the components
  • Technical File preparation and storage procedure

What is CE Mark, What Benefits CE Mark Provide?

The CE Certificate/mark is an important indicator of a product’s compliance with EU legislation and ensures the free movement of products in the European market.

Only product categories that are subject to certain directives providing CE marking are required to bear the CE marking.

CE Marking should not mean that a product is produced in Europe. CE Mark should mean that a product can be sold in the European and Turkish markets by meeting the minimum legal criteria. Even if the product is produced elsewhere, it definitely needs a CE Certificate to be able to enter the EU market and be sold.

It is the manufacturer’s responsibility to carry out the conformity assessment, create the technical file, publish the EC declaration of conformity and affix the CE marking on a product. Distributors must verify the presence of both the CE mark and the necessary supporting documentation. If the product is imported from a third country, the importer must verify that the non-EU manufacturer has taken the necessary steps and documents are available upon request.

Frequently Asked Questions

FAQ

We often see the letters CE on the products we buy, from children’s toys to electronics, windows and other construction products.

Although CE Certification/Marking may seem like a fairly simple concept, it is actually very complex as it does not apply to every product on the market and different items have to meet different requirements.

Below are answers to some of the most frequently asked questions about CE marking to help you better understand European regulations:

1. What is the CE mark?

The CE mark is a self-declaration marking that demonstrates the conformity of products with health, safety and environmental protection legislation in Europe.
Products that meet the requirements of the relevant Regulations are CE marked to demonstrate their compatibility and for free movement in participating countries.

The letters CE are an abbreviation of Conformité Européene, meaning “European Harmony”.

2. What are Product Regulations?

Directives are the legal regulations of the European Union.

Product directives are the basic requirements, performance levels and standards that products must comply with.

The requirements, performance levels and test requirements for construction products are specified in the harmonized European Standards (hEN) and European Technical Assessments (ETAs).

3. Which countries require CE marking?

Countries that require CE marking are 31 countries in the European Economic Area.

These are: All 28 EU member states: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania , Slovakia, Slovenia, Spain, Sweden and England.
Three members of the European Free Trade Association: Iceland, Liechtenstein and Norway.
In addition, Turkey has fully implemented most of the CE marking directives, even if it is not a member of the EU or EEA.

Switzerland is also not an EU or EEA member. However, it is part of the European Free Trade Association, so for some products it accepts CE marking as an assumption of conformity with its national technical regulations.

4. What products does the CE mark cover?

CE marking is not required for all products. However, it applies to many goods, such as electronics, toys, machinery, medical devices, and vehicles, as well as many construction products.

The Construction Products Regulation came into force on 1 July 2013 and states that manufacturers of construction products will have to apply CE marking to any of their goods covered by the hEN or ETA before placing them on the market.
5. How can I check if my product is CE marked?

The easiest way to check that a product has the CE mark is to look for the symbol. It should be on the product itself or the information that comes with or on the packaging.

If you suspect that a manufacturer has misused the CE mark, you can request a certificate of conformity and/or a declaration of performance.

6. What is the correct symbol to look for when checking the CE mark?

The official CE marking includes the letters C and E and their shapes are based on a series of circles. There should be a certain spacing between letters – if you think the inner curve of C is a full circle, then the outer curve of E should align with that circle.

The CE mark should always be at least 5mm high and should be included in the packaging or accompanying documents unless there is a reason why the logo cannot be attached to the product itself.

It is possible to find products that appear to be CE marked but have the wrong dimensions or proportions. Often times, the C and E picture will be seen much closer than the icon.

This can mean one of two things:

The product should bear the CE mark, but the manufacturer used the wrong symbol.
The product must not bear the CE mark (it is not required or because the product does not comply with the relevant standards) and the product has been illegitimately (and incorrectly) marked.

7. What if a product does not comply with CE marking requirements?

If a product that requires a CE Certificate/Mark does not meet the relevant requirements, it cannot be legally sold in participating countries.

If a manufacturer signs a CE-marked product by mistake or fails to CE mark a product for which it is required, it is subject to relevant penalties.

8. Are CE Mark test standards mandatory?

If a product complies with at least one of the relevant directives and a relevant compliant standard exists then yes, testing standards are mandatory and products must comply with these requirements.

9. What are the manufacturer’s responsibilities regarding CE marking?

A manufacturer is defined as the person responsible for designing and producing a product intended to bring it to market using his own name or brand.

It is the manufacturer’s responsibility to ensure that the products are designed and produced in accordance with the relevant legislation. They must also prepare the necessary technical documentation and ensure that appropriate evaluation procedures are in place.

Once compliance has been demonstrated, a manufacturer must write a declaration of performance and/or certificate of conformity and affix the CE marking to the product.

Other responsibilities include:

Maintaining records such as technical documentation and statements of performance.
Ensure proper procedures are followed so mass productions remain viable. FPC Factory Production Control
Make sure products carry a type, batch or serial number for identification purposes. It can also be found on the packaging or a document accompanying the product.
Name, registered trade name and a contact address. This must be on the product, packaging or a document accompanying the product.
The delivery of a product comes in a language that end users can easily understand, along with instructions and safety information.
Taking appropriate action if you think a product is not in compliance with applicable legislation. This may mean correcting the problem, withdrawing or recalling the product.
To provide information and documents to national authorities necessary to demonstrate the conformity of a product.

10. What are the responsibilities of the importer regarding CE marking?

When products are manufactured abroad, importers are responsible for ensuring compliance with applicable directives. In these cases, the importer is considered the manufacturer.

There have been cases where an importer was unable to produce the required documentation to prove CE marking compliance and customs authorities refused entry for shipment.

11. What are the responsibilities of a seller regarding CE marking?

Sellers have a legal responsibility to ensure that all related goods they sell are CE marked.

Under the provisions of this regulation, authorities can enter the building, test products and seize documents and goods. Authorities can also force manufacturers to recall or replace faulty items.

12. What is the relationship between CE marking and product liability?

According to the European Product Liability Directive, consumers do not have to prove that a product has caused damage. Because manufacturers are responsible for damage caused by a fault in a product, they must be products that prove that a product is not faulty.

Since CE marking generally contains minimum safety requirements, manufacturers can use certificates of conformity, related test results and other CE marking related documentation to demonstrate conformity. However, CE marking does not indicate that a product has been approved as safe by the EU or any other authority.

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