Systems of quality managment
CE certification - CE marking and everything you need to know
There are many products on the market and each one is subject to different European or national legislation and other technical regulations. The main goals are primarily to ensure the quality and safety of the given products for consumers. You can find out whether a given product meets all the necessary requirements, for example, through the markings on the packaging. One of these is the CE marking.
In the following lines, we will look at exactly what this label means, who must place it on their products, and we will also answer many other questions regarding this "certification".
What does the CE mark mean and what product is it placed on?
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 EFTA countries.
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 must not be placed on a product other than the product specified by these regulations!
CE is the only marking 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.
Mandatory CE marking
It is mandatory to use the CE mark on a wide range of products, starting from electrical devices, through toys, to construction products or machinery. These are product categories to which special EU directives apply.
CE marking is mandatory for these products:
• active implantable medical devices
• cable cars designed for transporting people
• equipment related to energy consumption (refrigerator, TV, light bulb)
• electrical / electronic equipment (electromagnetic compatibility)
• devices and protection systems intended for use in explosive atmospheres
• explosives for civil use and pyrotechnics
• hot water boilers
• equipment burning gaseous fuels
• diagnostic medical devices in vitro
• elevators
• construction products
• machines
• devices 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 hazardous substances
It follows from this that not all products sold on the European market may have the CE mark. The label must not be placed on, for example, chemicals, cosmetics, food and other products.
Exemptions from the CE marking
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 manufactured individually or tailored according to the customer's needs
• traditional practices must be followed during production 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, it may happen that you will face problems with the control authorities that supervise the market.
What are the benefits of CE marking?
In addition to the fact that the CE marking and product conformity assessment process is mandatory, it also has its indisputable advantages, such as:
• no additional certificates or testing are required,
• the possibility to do business in any country of the European internal market without the need to prepare additional documentation,
• easier product comparison for customers,
• promoting product credibility.
Thanks to the CE mark, you can trade with your product in any country of the European internal market without having to create new documentation.
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.
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.
How to get the CE mark?
The sole responsibility for the assessment of conformity and declaration of conformity of the product with all requirements rests with the manufacturer. You do not need a license to secure the CE mark for your product, but before doing so, you must complete the following requirements:
• ensure product compliance with all 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/EC Declaration of Conformity,
From the moment your product bears the CE mark, you are obliged to provide the relevant national authority with all documentation and information regarding your product 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, it must contain all the facts that confirm the conformity of the product with the applicable requirements. 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. The exception is the instructions for use and the declaration of conformity. These documents must be attached to the customer in the official language of the country to which the product is sold.
All information about the necessary documents, their content and the procedures for assessing product conformity are given in the given guidelines and regulations for a specific product group.