European Conformity
CE stands for “Conformité Européene” in French, which means “European Conformity”. Although the term “CE Mark” is sometimes used in newspapers and other articles on the subject, the official and the correct term is “CE marking”. And this is what is used in the directives for various products.
The letters “CE” appear on many products traded in the European Economic Area (EEA) market. They indicate that products sold in the EEA have been assessed to meet safety, health, and environmental protection requirements.
The CE mark indicates compliance with health, safety, and environmental protection standards for products sold in the European Economic Area. The CE mark is also found on products sold outside the European Economic Area that are manufactured to EEA standards.
We are with you step by step until obtaining the CE mark.
At the ISO Consult Center, we guide you step by step through the principles of CE marking. We explain many of the terms used in the context of CE marking. in addition, you can get answers to many of the questions you usually have when starting CE marking. We introduce you to different product directions and areas.
We will help you step by step take you through the ten steps and introduce you to the principles and methods of CE marking a product. CE marking is not just about affixing the CE mark to a product. When you receive the CE mark, you also take responsibility for your product’s compliance with the law.
Depending on the specific directives for your product, the work steps may differ slightly. Depends on the product and the relevant directives.
The ten steps are as follows:
1- Choose the appropriate European directive for your product
In the list of product groups, you can see if your product must have the CE mark. There are also products that are excluded from these directives. For example, the Toys Directive states that jigsaw puzzles with more than 500 pieces are exempt, as a puzzle with this number of pieces is not considered a toy.
It is critical to note that a product may be covered by more than one directive. For example, an electric meat grinder is covered by the Machinery Directive and the Low Voltage Directive.
2- Check the date CE marking was applied to your product.
The date on which the CE mark is required for your product can be found in the directive. The same date applies to all products covered by a directive. When a newly-enacted directive or a revision of an existing directive enters into force, the date on which CE marking must be applied is specified in the directive.
The conformity assessment method can be found in specific directives. Procedures may vary from directive to directive. In most cases, manufacturers can carry out the conformity assessment themselves, but if the directive states that a third party is required, the manufacturer must entrust the carrying out of the conformity assessment to one of the notified bodies designated for the region.
4- Ensure that your product complies with the essential requirements of the directive.
EU directives for CE marking have been prepared to include essential safety requirements for products. Consequently, part of the CE marking process is to address the essential safety requirements of the relevant product directives.
All essential safety requirements must be met before the CE mark can be affixed. However, as the directives cover a product group, there may be safety requirements that do not apply to the specific product. For example, there may be a requirement to limit “noise” in the Directive for the product group, but if the particular product does not emit “noise”, these essential safety requirements are not relevant in the particular case.
If a harmonized standard exists, this is the right place to find the essential requirements
This is because harmonized standards contain essential requirements. Therefore, they provide a presumption of conformity, i.e., compliance with the requirements of the standard entitles the manufacturer to assure compliance with the requirements of the Directive.
5- Check if there are applicable standards for your product.
For example, a standard could include a description of how to design a toy for young children. Or provide a suitable design standard for an electric hospital bed.
However, there may not be a specific standard for the product in question. In this case, the manufacturer must find other ways to meet the requirements of the directive: for example, finding a standard for a similar product and using other standards.
6- Preparation of technical files (technical documents)
The preparation of technical documents is the responsibility of the manufacturer. Technical documentation also called a technical file, must be a document that demonstrates the product’s compliance with the requirements of the directive. The requirements for what technical documentation must contain are set out in separate directives. If more than one directive applies to a product, the technical documentation must meet the requirements of all directives.
As a rule, documentation should cover product design and functionality.
Examples of technical documents:
Manufacturer’s name and address.
Design and construction information, drawings,
A list of standards used.
Risk assessment
Test report, if applicable.
Directives used,
Declaration of conformity/declaration of performance
As a rule, the manufacturer must prepare and keep technical documentation for at least 10 years from the last date the product was manufactured and placed on the market. The requirements for the duration of technical documentation storage may differ in different directives.
7- Complete the compliance statement.
When your product is ready to be placed on the market, you must prepare a declaration of conformity. This information should include information on directives, standards, information on the contact details of the manufacturer, and details of any notified third party or organization.
With the technical documentation and declaration of conformity, you declare that it is your responsibility as a manufacturer to ensure that the product complies with the requirements of the directive and that you have carried out all necessary assessments.
8- Check whether there are national laws in the country where the product is to be sold or not.
One of the purposes of CE marking is to ensure the free movement of goods in the EU and EEA countries. In this context, the CE mark is comparable to a travel card. This means that EU national authorities cannot impose stricter requirements on a product than those agreed by member states. However, each country may have specific conditions for the product in terms of use. For example, there may be special conditions for elevator service. Moreover, the customer is always free to specify requirements that extend beyond the requirements of directives or regulations.
9- Paste the CE mark on the product.
The location of the CE mark and the design of the CE mark may vary depending on the product in question. Detailed guidelines for positioning, content, and design are provided in the Harmonized Standard. In the absence of a harmonized standard, the general directives provided apply.
10- Other rules
The CE mark is affixed to the product, but is there anything else? No, because there may be other harmonized standards that must be followed, but are not directly related to the CE mark. For example, the WEEE Directive, which covers all electronic products, the Packaging Directive, the REACH Regulation, and the Battery Directive. So, check the other rules for your product.
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Manufacturers play a vital role in ensuring the safety of products placed on the EEA market. It is their responsibility to carry out the conformity assessment, draw up the technical file, issue the EU declaration of conformity and affix the CE mark to a product.
Manufacturers have an active role to play in ensuring that products placed in the European Economic Area (EEA) market are safe. They are responsible for checking whether their products meet EU safety, health, and environmental protection requirements. The manufacturer is responsible for carrying out the conformity assessment, drawing up the technical file, issuing the EU declaration of conformity, and affixing the CE mark to the product. Only then can this product be traded in the European Economic Area market.
If you are a manufacturer, you must take the following steps to affix the CE mark to your product.
Identify applicable directives and harmonized standards.
Confirm product-specific requirements.
Determine whether an independent conformity assessment (by a competent body) is necessary.
Test the product and verify its conformity.
Prepare and keep available the required technical documents
Affix the CE mark and draw up the EU Declaration of Conformity.
Importers and distributors help ensure that only CE-marked products are placed on the European Economic Area market in compliance with EU legislation. As intermediaries between manufacturers and consumers, they must be aware of legal requirements and ensure that the products they distribute, or import meet the requirements.
In the European Union, consumers may have different preferences regarding the color or brand of products, such as newly purchased laptops or toys for their children. At the same time, they expect all products on the market to be safe.
When you buy a new phone, teddy bear, or TV in the European Economic Area, you can find the CE mark on them. The CE mark also supports fair competition by holding all companies accountable to the same rules.
By affixing the CE mark to a product, a manufacturer declares that the product meets all the legal requirements for the CE mark. The product can be sold throughout the European Economic Area. This also applies to products made in other countries that are sold in the European Economic Area.
There are two main benefits of CE marking for businesses and consumers in the EEA:
Businesses know that CE-marked products can be traded within the EEA without restrictions.
Consumers enjoy the same level of health, safety, and environmental protection across the EEA.
CE marking is part of EU harmonization legislation, mainly managed by the Directorate General for the Internal Market, Industry, Entrepreneurship, and SMEs. The CE mark for the restriction of hazardous substances is managed by the General Directorate of the Environment. Comprehensive guidance on the implementation of EU product legislation can be found in the blue guide.
Not all products should have the CE mark. It is only mandatory for many products covered by the revised approach directives. Placing the CE mark on other products is prohibited.
The process of determining whether a product needs a CE mark is somewhat complicated. Manufacturers must determine:
In which countries do they want the product to be introduced? European Economic Area (EEA) or EFTA countries require the CE mark if the product is covered by one or more CE marking directives.
If Turkey is the target market. While Turkey is neither a member of the EU nor part of the EEA, it has implemented several CE marking directives. This means that many products here also require a CE mark.
Toys, machinery, and electrical appliances are all examples of products that carry the CE mark.
What they have in common is that they fall under one of the directives for which the European Union has adopted the CE mark. Each product directive covers several product groups. For example, lifting devices and household appliances are a product group under the Machinery Directive. Product groups in the directives have been selected to focus specifically on safety, health, and the environment.
Only products marketed or used in the European Union must bear the CE mark
There is a wide range of products and equipment that must have the CE mark before being marketed, sold, and used in the European Union and the European Economic Area. These include toys, machinery, electrical appliances, and medical products. A product may be covered by several directives, just as a directive may cover many products.
The following product categories are covered by at least one of the CE marking directives:
Medical
Equipment Active implantable
Medical devices,
Laboratory diagnostic medical devices
Construction products
Electrical equipment.
Electronic equipment
Personal protective equipment
Pressure equipment
Simple pressure vessels
Gas devices
Terminal equipment
Radio and telecommunications
Elevators
Cableways
Protective equipment and systems for use in explosive atmospheres.
Explosives for civilian use
Updated hot water boilers
Measuring instruments
Non-automatic weighing devices
Toys
Recreational crafts,
The following product categories do not require CE marking:
Cosmetics
Food
Materials
Pharmaceutical chemicals
However, cosmetics and other products are still covered by other European or national legislation (and usually the General Product Safety Directive 2001/95/EC if no specific legislation applies) they just don’t need to be labeled.
The ISO consult center has many years of experience in providing advice and guidance to manufacturers of medical equipment and cosmetic, chemical, and technological products. This experience has helped them to introduce their designs and products to the European Union market. Contact us.
CE marks enable companies to reach global markets and increase exports. The product must have a CE mark e to sell in the European Union
In other countries, obtaining the CE mark gives you an edge over your competitors.
