Everything you need to know about CE certification.

The sale of products is subject to many laws and must meet several conditions (not only) regarding quality. You can find out whether a given product meets all the necessary requirements through the markings on the packaging. One of them is the CE marking.

In the following lines, we will look at what this label means, who must put it on their products, and we will also answer many other questions regarding this certificate.

What is a CE certificate?

The CE certificate indicates products that comply with European Union legislation and can therefore be freely sold on the European market. By attaching the CE mark to its product, the manufacturer declares under its own responsibility that this product complies with all legal requirements for this mark and can therefore be sold throughout the European Economic Area and Turkey. The European Economic Area (EEA) includes 27 member states of the European Union and the EFTA countries, i.e. Norway, Iceland and Liechtenstein.

Not all products sold in the European Union may have the CE mark, certification is required only for certain categories of products that specify the directives on the use of this mark.

CE is the only mark that means compliance with all the requirements that are imposed on the manufacturer regarding his product based on the directives. The states of the European Union must not have references in their national regulations to any other markings of conformity that would be related to the CE marking.

Other markings or brands may be applied to the product only if they meet the following conditions:

• have a different function than the CE marking,

• any confusion with the CE marking is excluded,

• and in no way impair the readability and visibility of the CE marking.

The CE marking replaces all mandatory product conformity markings that have the same meaning as CE and existed before harmonization.

Mandatory CE marking

It is mandatory to use the CE mark on a wide range of products, starting with electrical equipment, through toys, to medical devices or civilian explosives. These are product categories that are covered by special EU directives.

CE marking is mandatory for these products:

• active implantable medical devices

• cable car equipment intended for transporting people

• equipment related to energy consumption (fridge, TV, light bulb)

• electrical/electronic devices (electromagnetic compatibility)

• devices and protective systems intended for use in an environment with a risk of explosion

• explosives for civil use and pyrotechnics

• hot water boilers

• devices burning gaseous fuels

• diagnostic medical devices in vitro

• elevators

• construction products

• machines

• devices working with low voltage

• measuring devices

• medical devices

• devices associated with the emission of noise into the environment

• scales with non-automatic operation

• personal protective work equipment

• pressure device

• radio and telecommunication end devices

• recreational boats and vessels

• toys

• pressure vessels

• devices containing dangerous substances

Not all products sold on the European market may have the CE mark. It is not required, for example, for chemicals, cosmetics, food, etc.

Exemptions from the CE marking
As with everything, there are exceptions to CE certification. As a manufacturer, in some cases you are not obliged to place the CE mark on your product, despite the fact that the product and its intended use are subject to a harmonized standard. And that's if:

• the product is manufactured individually or tailored according to the customer's needs

• it is necessary to follow traditional procedures during production in order to preserve officially protected buildings

To use one of these exceptions, it is better to check in advance that it also applies to your product without debate. Otherwise, you may face problems with the authorities that supervise the market.

Why is it worth having the CE mark?

• No additional certificates or tests are needed,

• The possibility to trade in any country of the European internal market subject to further documentation,

• Easier product comparison for customers

• Product credibility support.

The advantage of the CE mark is that if your products have it, they must be allowed to be sold in all countries where this certificate is valid. The public authorities of the country can no longer ask you for additional certificates, marks or additional testing.

Thanks to this, you can trade with your product in any country of the European internal market without having to create new documentation.

You will make it easier for your customers to compare products. Thanks to the CE marking and the declaration of parameters, end users can better verify the properties of the product and at the same time compare them with other products within one technical approach.

At the same time, you will also support your credibility, since attaching the CE mark to the product means in practice that you have ensured that the parameters of the product sold correspond to the parameters in your declaration. And also that these parameters correspond to the correct European technical specification.

In addition, the CE marking contains important main information about your product and links to other documents with additional information.

How to place the CE mark on a product?

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First of all, the CE marking on the product must be visible, legible and indelible. The CE initials that make up the mark must have the same height, at least 5 mm. However, some categories may have different requirements for the size of the letters. When increasing or decreasing the letters, you must maintain their proportions. If the CE marking remains sufficiently visible, you can place it on the product in different graphic variations, for example matching it with the color of the product.

However, it is not always possible to place the CE mark directly on the product. What about that? Then you can find a place for it on the packaging or in the accompanying documentation.

If your product is covered by several European regulations or directives that require CE marking, you should have in the accompanying documentation that the product complies with all valid EU regulations.

How to get the CE mark?

The manufacturer bears sole responsibility for the declaration of conformity of the product with all requirements. You don't need a license to secure a CE certificate for your product, but before you do, you need to complete the following requirements:

• ensure compliance of the product with all the requirements of the European Union
• determine whether you can assess the product or you are obliged to ask a notified body
• compile technical documentation that proves compliance
• create and sign the EU Declaration of Conformity

From the moment your product bears the CE mark, you are obliged to provide the relevant national authority, upon request, with all the documentation and information related to this mark.

Technical documentation for CE marking equipment

The content of the technical documentation required for CE marking is information on the design of the product, its manufacturer and also on the way it works. In addition, all the facts that confirm the product's compliance with valid requirements must be listed there. The introduction of any product to the market must be preceded by certain actions:

• preparation of technical documentation
• ensuring that market surveillance authorities have access to technical documentation on request from the moment the product is placed on the market
• retention of technical documentation for 10 years from the introduction of the product

The technical documentation must also contain relevant information, such as the name and address, a brief description of the product, product identification, the name and address of all companies that worked on the product and also all notified entities that assessed the conformity of the product.

Furthermore, the technical documentation must not lack the conformity assessment procedure, EU declaration of conformity, instructions for use, list of regulations and technical standards that the product meets, list of product parts or test results.

You can usually choose the language in the technical documentation according to your preferences. In some cases, however, market surveillance authorities may ask you to translate it into another language. It depends on the country of the European Union in which the product is marketed. In that case, however, the documentation does not have to be in printed form, an electronic version is sufficient.

Declaration of Conformity

The declaration of conformity is a mandatory document that must be signed by the manufacturer or his authorized representative, thus confirming that the products meet the requirements of the European Union. With this signature, the manufacturer also assumes full responsibility for product compliance with legal regulations. The statement must contain:

• the name of the manufacturer and the full address of the company
• production number, model or designation of the product type
• declaration of taking full responsibility for the product
• product identification method
• data on the notified body that carried out the conformity assessment
• legal regulations with which the product complies and harmonized standards that demonstrate compliance
• name and signature
• the date of the declaration
• and any additional information

Finally, the declaration of conformity must be translated into the languages ​​of the European Union countries in which the product is sold.