CE Certification

EVERYTHING YOU NEED TO KNOW ABOUT CE CERTIFICATION:

• What Is CE Certification?
• Why Is CE Certification Important?
• What Countries Require CE Compliance?
• Which Products Need a CE Mark?
• Products That May Be Sold Without a CE Mark
• How to Obtain CE Certification?
• How to Get CE Certification?
• Responsibility of Manufacturers for CE Certification
• Responsibility of Distributors for Products with a CE Mark
• What does CE Mark mean?
• CE Certification: Other Directives
• Become CE Certified with 360Compliance
• Frequently Asked Questions about CE Marking

WHAT IS CE CERTIFICATION?

When entering the market of the countries of the European Union (EU) and the European Economic Area (EEA), goods of certain categories require the CE marking. This abbreviation stands for “European Conformity” (Conformité Européenne) and serves as proof that the product has been tested for compliance with all EU Directives. This practice was introduced in 1985 to accredit market access for both domestic and foreign producers. The CE mark on a product means that it complies with all established EU regulations regarding the safety of human health and the environment.

WHY IS CE CERTIFICATION IMPORTANT?

CE certification confirms that the product entered the market legally, has all the permits, and does not pose any threat to human health or the safety and integrity of the environment. Thus, the CE mark signals both buyers and official regulators about the successful completion of all testing and certifying procedures.

WHAT COUNTRIES REQUIRE CE COMPLIANCE?

The mandatory CE certification applies to products entering the market of all 30 countries of the European Economic Area (EEA). It also covers Switzerland and Turkey, which have signed a number of bilateral agreements with the EU, including the CE marking requirement.

WHICH PRODUCTS NEED A CE MARK?

To date, CE marking applies to products whose market access is regulated by 25 Directives and Regulations. These groups of goods are subject to special control and thorough testing since non-compliance with safety standards during their production or operation can cause harm to people or the environment. The list includes the following product groups:

• Construction products;
• Measuring equipment of different types;
• Medical devices;
• Pyrotechnics and explosives;
• Telecommunication and radio equipment;
• Gas appliances;
• Yachts, boats, and other watercraft;
• Pressure equipment;
• Kids toys;
• Water heaters and boilers;
• Personal protective equipment;
• Cableways and lifts;
• Noisy equipment;
• Electrical equipment, and others.

PRODUCTS THAT MAY BE SOLD WITHOUT A CE MARK

Although CE marking is required for a wide range of products, not all goods imported into the listed countries need to pass this type of certification. In particular, goods belonging to the following categories, which are covered by other Directives, are subject to a different type of certification:

• Chemical products
• Cosmetics
• Food products
• Pharmaceuticals

HOW TO OBTAIN CE CERTIFICATION?

Obtaining a CE mark is a standardized procedure consisting of several stages with documental confirmation of their passage. It starts with determining the list of Directives that apply to certain products, then comes the data collection, technical assessment, and passing all testing procedures. When the CE marking of products is completed, they can be launched to the market.

WHAT IS CE CERTIFICATION PROCESS?

Determining the Directives and Standards Applicable to Certified Products

The Directives include general safety requirements for products placed on the market. The specific parameters and technical requirements are detailed in the harmonized standards. If CE marking is required for a product that does not fall under any of the Directives, a document stipulating general safety requirements applies to it.

Examining the CE Requirements

Harmonized standards are being studied to check whether the proposed product complies with all safety criteria and whether it can qualify for the CE mark.

Compiling the Necessary Supply Chain Data

Collecting technical files may require a lot of additional information depending on the product being certified. These can be technical drawings, documentation on the materials used to manufacture the product, wiring diagrams, and other details. All of them must be collected to expedite the CE marking procedure.

Determining the Need for Authorized Body to Be Involved in the Product Evaluation Process

Notified bodies (NB) participate in the certification process if it is specified in the Directives. In such cases, they audit all documents to ensure that the manufacturer has complied with all requirements. If the Directive does not require the participation of NBs, manufacturers may carry out the conformity assessment themselves.

Passing Test Procedures

Product testing is conducted by certified laboratories that confirm the safety of the product and its compliance with the criteria for obtaining the CE certificate. The result of this stage is a special laboratory test protocol, on the basis of which a certificate is issued.

Preparation and Issuance of the CE Documentation

At this stage, appointed experts check all collected papers, compare them with Directives and standards, and make a decision regarding the CE marking. In case of successful completion of the certification procedure, the manufacturer receives the CE mark and all required documents and can proceed to product labeling before launching it on the market.

The manufacturer also draws up technical documentation, which confirms that the product has been certified, supporting its compliance with all standards.

Preparation of the EU Declaration of Conformity and Placing the CE marking

To import certified products into the territory of the EEA, a Declaration of Conformity is required for both manufacturers and/or distributors. It is drawn up by the manufacturer and is provided to distributors who will be engaged in the supply of goods on the territory of the EEA.

CE marking is applied to the data plate of the product or to its package if, for technical reasons, it is not possible to stamp it directly on the product. This is the final stage, after which the product may be launched to the EU and EEA markets.

RESPONSIBILITY OF MANUFACTURERS FOR CE CERTIFICATION

To successfully complete the standard procedure for obtaining the CE mark, manufacturers must find out which EU Directive regulates the access of products of their category to the market and check compliance with all regulations. After that, a conformity assessment is carried out, on the basis of which a technical file is prepared. Further, the EU authorized body examines the documents, and the manufacturer issues the EC Declaration of Conformity (DoC). When all documents are certified and the CE mark is received, the manufacturer can label with this mark their products and packaging.

RESPONSIBILITY OF DISTRIBUTORS FOR PRODUCTS WITH A CE MARK

Distributors of goods in the EU market must ensure that the CE mark has not yet expired and that the certificate itself is not fake. They also check the placement of the stamp on the product or its packaging since marking is the responsibility of the manufacturer.

WHAT DOES CE MARK MEAN?

CE marking of goods is a declaration of the safety of goods for consumers and the environment by the manufacturer. The safety criteria are determined on the basis of the EU Directives, which specify the standards that products must meet when offered to consumers in the EU and other EEA countries. Therefore, the presence of the CE mark means that:

• All potential risks connected with the operation of the product are checked and meet the standards adopted in the EU.
• All New Approach Directives of the EU have been taken into account and observed.
• The proposed product will not harm the environment or the people using it.

CE CERTIFICATION: OTHER DIRECTIVES

The admission of goods to the EU and EEA markets is regulated by more than 20 Directives. Each group of products is covered by a specific Directive with established standards, for example, Toy Directive, Medical Devices Directive, Lifts Directive, EMC Directive, and others.

BECOME CE CERTIFIED WITH 360COMPLIANCE

The CE marking procedure can be tedious and incomprehensible to non-professionals. However, the 360Compliance team will help you pass all stages of certification quickly, competently, and successfully. You will receive full project management with no hassle. You are also guaranteed technical support and a transparent pricing policy.

To start the testing & certification process for obtaining a CE stamp, contact the 360Compliance team in any convenient way and get all the answers and instantly initiate the certification procedure.

FREQUENTLY ASKED QUESTIONS ABOUT CE MARKING

For how long is a CE certificate valid?

For each product group, a certain validity period is established, but in most cases, it is three years. After that, you need to go through the re-certification procedure. However, there are products for which the CE mark is valid for 10 years or more.

What are the penalties for the absence of a CE certificate?

Punishment for selling goods without the certificates in countries where the CE marking is mandatory varies widely from administrative to criminal liability. The specific article of the law that will be applied depends on the damage that a given product can cause to people or the environment.

How to get a CE certificate?

To obtain the CE stamp, it is necessary to go through a risk assessment procedure for the products offered. For this, you need to study the standards of the specific Directive that regulates access to the market for this type of products, make up a technical file, and pass testing. When all permits are issued, CE marking can be applied to the offered products.

How to authenticate a CE certificate?

You can authenticate a CE mark using the official database. Also, it is possible to contact the official authority that issued the certificate and request details on this product. If it turns out that this product is not registered with official institutions, you are dealing with fake certification.

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