CE certificate - everything you need to know - More here!
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 exactly what this label means, who must put it on their products, and we will also answer many other questions regarding this "certification".
What is a CE certificate?
The CE mark indicates products that comply with European Union legislation and can therefore be freely sold on the European market. By affixing the CE marking to its product, the manufacturer declares under its own responsibility that this product complies with all legal requirements for this marking and can therefore be sold throughout the European Economic Area and Turkey. The European Economic Area 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 guidelines for the use of this mark. The CE mark may not be affixed to products other than those specified by these regulations!
CE is the only mark that means compliance with all the requirements that are based on directives or tech. regulations for the manufacturer regarding his product laid down. The countries of the European Union may not have references in their national regulations to other markings of conformity that would be related to the CE marking.
The product can only have additional labeling if it meets the following conditions:
- have a different function than the CE marking,
- confusion with the CE marking is excluded,
- and do not in any way impair the legibility and visibility of the CE marking.
The CE marking is a replacement for 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 devices, through toys, to medical devices or civilian explosives. These are product categories to which special EU directives apply.
CE marking is mandatory for these products:
- active implantable medical devices
- cableways intended for passenger transport
- equipment related to energy consumption (fridge, TV, light bulb)
- electrical / electronic equipment (electromagnetic compatibility)
- equipment 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
- in vitro diagnostic medical devices
- elevators
- construction products
- machinery
- equipment working with low voltage
- measuring equipment
- medical equipment
- equipment associated with the emission of noise to the environment
- scales with non-automatic operation
- personal protective work equipment
- pressure equipment
- radio and telecommunication terminal equipment
- recreational boats and watercraft
- toys
- pressure vessels
- equipment containing dangerous substances
Not all products sold on the European market may have the CE mark. For example, it is not required 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, even though the product and its intended use are subject to a harmonized standard. And that is if:
- the product is produced individually or tailored according to the customer's needs
- it is necessary to follow traditional procedures during production in order to preserve the trademark of the product
To use one of these exceptions, you'd better check in advance that it definitely applies to your product. Otherwise, you may face problems with the authorities that supervise the market.
Why is it worth having the CE mark?
First of all, the CE marking is mandatory for products specified by the given EU directives when they are placed on the market - see the point above. Other benefits are as follows:
- no additional certificates or testing are required,
- the possibility to trade in any country of the European internal market without additional documentation,
- easier product comparison for customers,
- product credibility support.
The advantage of the CE mark is that if your products have it, their sale must be allowed in all countries in which this "certificate" is valid. The public authorities of the given country can no longer request additional certificates, marks or additional tests from you.
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. With the CE marking and the declaration of parameters, end users can better verify the properties of the product and at the same time compare it with other products within a single technical approach.
At the same time, you will also support your credibility, because 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 key information about your product and links to other documents with additional information.
How to place the CE mark on a product?
First of all, the CE marking on the product must be visible, legible and indelible. The CE initials that make up the marking must be of the same height, at least 5 mm. However, some categories may have different letter size requirements. To make the font larger or smaller, 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 with this? Then you can find a place for it on the packaging or in the accompanying documentation.
If your product is subject to several European regulations or directives that require the CE mark, you should have in the accompanying documentation that the product complies with all applicable EU regulations.
How to get the CE mark?
The sole responsibility for the declaration of conformity of the product with all requirements rests with the manufacturer. You don't need a license to get your product CE marked, but before you do, you need to complete the following:
- ensure product compliance with all European Union requirements,
- 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 an EU/EC declaration of conformity,
From the moment your product bears the CE mark, you are obliged to provide the relevant national authority with all the documentation and information related to this mark upon request.
Technical documentation for making the CE marking
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 conformity of the product with the applicable requirements must be stated there. Putting any product on the market must be preceded by certain actions:
- preparation of technical documentation,
- ensuring that market surveillance authorities have access to technical documentation upon request from the moment the product is placed on the market,
- retention of technical documentation for 10 years from the launch of the product.
Even the technical documentation must 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, as well as all notified bodies that assessed the product's conformity.
The technical documentation must also include the conformity assessment procedure, EU declaration of conformity, instructions for use, list of regulations and technical standards that the product complies with, 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 require you to translate it into another language. It depends on the European Union country 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 to confirm that the products meet the requirements of the European Union. With this signature, the manufacturer also assumes full responsibility for the product's compliance with legal regulations. The statement must include:
- the name of the manufacturer and the full address of the company,
- serial number, model or designation of the type of product,
- declaration of acceptance of full responsibility for the product,
- product identification method,
- details of 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,
- date of issue,
- and any additional information.
Finally, the declaration of conformity and the instructions must be translated into the languages of the European Union countries in which the product is sold.