Pro-Application Service provides testing and advisory services to help you get your products to Europe. If you are new to this regulartory, you can take a few minutes to read this page. It will guide you through what CE Marking is, and what we can help you.
What is CE Marking?
CE Marking is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). Member countries in European Economic Area are 27 countries from European Union (EU) and 3 countries from European Free Trade Association (EFTA), total 30 countries. For convenient reason, we often speak of these member countries as EU.
Officially, CE has no meaning as an abbreviation, but may have originally stood for Communauté Européenne or Conformities Europeans, French for European Conformity.
By affixing the CE marking, the manufacturer, its authorized representative, or person placing the product on the market or putting it into service asserts that the item meets all the essential requirements of all applicable directives and that the applicable conformity assessment procedures have been applied. The CE marking is a legal way to declare that all requirements have been complied with in relation to safety. It can also be viewed as a mark of access to the free market of the EU.
Many non-EU exporters are finding that no matter how interested a prospective EU importer may be in the product, the importer will NOT risk importing non-conforming products (i.e. the products without CE Marking) which, in case of accident, may generate legal action against them. The liability claims in a law suit can be as high as 70 million EUROs.
List of EEA Countries (as of December 1st, 2009)
- Czech Republic
- Malta Netherlands
- United Kingdom
What products are needed to be CE marked?
Here are examples (but not limitation) of products falling in the scope of CE Marking Directives;
- Appliances Burning Gaseous Fuels (AppliGas)
- Cableway Installations to Carry Persons
- Low Voltage Electrical Equipment (LVD)
- Construction Products
- Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (ATEX)
- Electromagnetic Compatibility (EMC)
- Explosives for Civil Uses
- Hot Water Boilers
- Household Refrigerators & Freezers
- Machine (MD)
- Marine Equipment
- Medical Devices (MDD)
- Active Implantable Medical Devices
- In Vitro Diagnostic Medical Devices (IVDD)
- Non-automatic Weighing Instruments
- Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
- Personal Protective Equipment (PPE)
- Simple Pressure Vessels
- Pressure Equipment
- Recreational Craft
Who is responsible for CE Marking?
In these cases hereafter need CE Marking on the products:
- Marketing of a product produced within an EEA country.
- Direct import of a product from a non-EEA country.
- Building a new product from components within an EEA country.
CE Marking Directives
A European Directive can be regarded as a European law, and - unlike its name may assume - is legally binding for every Member State of the European Union. Through transposition into the national legislation of the Member States, persons and companies are subject to the requirements of the European Directives. Not all directives required CE marking.
Examples of European Directives requiring CE marking include toy safety, machinery, low-voltage equipment, and electromagnetic compatibility (EMC). There are 25 Directives requiring CE marking.
A harmonized standard provides a 'presumption of conformity' of meeting an Essential Requirements and meets 'State of the Art' intent of the directive. That means, by using a harmonized standard, you have satisfactorily met the minimum amount required to meet Essential Requirements. CE Marking Directives usually harmonize with consensus standards called EN Standards adopt by CENELEC and CEN.
Generally, CENELEC is responsible for European Standardization in the area of electrical engineering. Together with ETSI (telecommunication) and CEN (other technical areas) CENELEC form the European system for technical standardization.
Standards harmonized by these agencies are regularly adopted in many countries outside Europe which follow European technical standards.
Documentation - Technical Construction File
Every CE Marking directive requires the manufacturer or importer to compile and keep available for inspection a Technical Construction File. The purpose of the Technical Construction File is to provide documented evidence of the product's compliance. Therefore the Technical Construction File should contain at least all information about the product which allows the authorities to:
- identify the product;
- determine the configuration of the product that was approved;
- determine which standards were applied;
- determine which directives were applied;
- determine how the product meets the requirements of the relevant directives and standards;
- identify the manufacturer and manufacturing process;
- determine how the manufacturer ensures consistent quality of production and continuous product compliance.
The Technical Construction File must be kept available for at least 10 years after the date of the last manufacture of the product.
Which documentation exactly needs to be provided in the Technical Construction File is stipulated in the text of the directives and can be much varied. However, mostly general descriptions of documents are given, and the directives do not specifically list the documents that need to be provided. As a rule, the Technical Construction File should cover the design, manufacture and operation of the product.
Examples of documents that should be included in the Technical Construction File are:
- drawings, schematics, block diagrams, PWB layouts;
- users manuals;
- copy of the product label;
- list of the applied standards;
- test reports and certificates.
Declaration of Conformity
Most CE Marking directives require that the manufacturer signs a 'Declaration of Conformity'. With the Declaration of Conformity the manufacturer states the fulfillment of the requirements of the relevant directives and standards. It should contain the references to the directives and standards that have been applied, a product specification and the contact details of the manufacturer. The Declaration of Conformity must be signed by a person authorized to legally bind the company. The Declaration of Conformity is kept available in the Technical File. Whenever a distributor or authority requests, the manufacturer may send a copy of the last version of the Declaration. The text should be in one of the official languages of the European Union. English, however, is the most accepted language.
Most of CE marking directives can be entirely self-declaration, that is, the manufacturer is responsible for the relevant products CE marked. Some directives, such as Medical Device Directive, required Notified Body to be involved in conformity assessment process. When a Notified Body has been involved in the conformity assessment, some directives require that the four digit identification number of the Notified Body is affixed next to the CE Marking. Manufacturer, however, still have to self declare the conformity after obtaining the identification number and still take full responsibility for their products.
Affixing the CE Marking
Once all requirements stated in the relevant directives have been met, the manufacturer or his authorized representative can affix CE mark on the products. By affixing the CE Marking the manufacturer confirms that the product meets the applicable CE requirements. It is not allowed to affix the CE Marking to products that do not comply, or to products that do not fall within the fields of application of the CE Marking directives. That is a criminal offense that may be prosecuted.
The CE Marking is made of the letters “CE” in accordance with the following diagram:
If the CE marking is reduced or enlarged, the relative dimensions must still be observed. At the same time, the Directive says that the CE marking must at least be 5 mm in height. However, exceptions can be made in connection with very small products or appliances.
If the products or the appliances are covered by more than on CE Marking Directive, the CE marking will also indicate compliance with these directives. The CE marking must be placed in a way that it is visible, easy to read and cannot be erased. It is prohibited to place another marking which may confuse others as regards to the meaning of the CE marking. However, it is allowed to place other marks (like D-Mark and UL-Mark) provided that these do not reduce the visibility or the readability of the CE Marking.
How can PRO help you in CE Marking?
By using our service, we will;
- advice you to prepare necessary documentation & prepare the complete application package for you to apply CE marking. The service covers a series of same products, not only one model.
- interface with notified/competence/certification bodies on your behalf providing your company with faster response, greater efficiency and shorter project turnaround time with our communication to ensure clear understanding.
- arrange your products to be tested at testing laboratories meet the correct harmonized EN standards and therefore provide clear visibility into such standards.
- assist you to handle the entire period of application, since you sign until you reach CE marking for the products you apply.
- assist you to solve problems by using appropriate methods.
- closely co-operate and follow up until completion of such projects.
Direct Contact to PRO Staff
For more information or if you have inquiry about CE marking, please contact:
+66 2363 7767~9
Or use contact form below.