The CE Certification (also known as CE mark or CE marking) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.

If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the members states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.

The New Approach Directives will provide a range of compliance routes for your product and show you, usually in a modular format, the available routes to compliance.

You must then decide which is the best fit for your company set up and follow the routes detailed in the Directive.

In many cases the compliance route will require you to use a Notified Body to assist with your certification.

The essential requirements of the New Approach Directives differ from directive to directive and product to product.

Countries requiring the CE Certification

The marking is mandatory for products sold not only within the 27 countries of the European Union (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) but more generally within all countries of the European Economic Area (EEA) which also includes the 4 countries of the European Free Trade Area (EFTA: Iceland, Liechtenstein, Norway, including Switzerland despite it is not a member of the EEA), as well as within Turkey (despite it is still not a member of any free trade area in Europe).

It is still not required within the countries members of the Central European Free Trade Agreement (CEFTA), despite some of them (Croatia, Serbia, Montenegro) are official candidates for membership to the European Union, and are already adopting many of its standards within their legislation (like the most of the former Central European countries that were members of CEFTA before joining the EU).

In some other European countries, the marking is not mandatory but it is almost always present (and in fact requested by customers that look for it) due to the proximity of markets and the existence of bilateral trade agreements or to the fact that a large part of the products are sold there for export to customers living in a country in the EES, or are imported from these countries (Monaco, Andorra, San Marino, Vatican, Jersey, Guernsey, Isle of Man) : for some classes of products, these countries may also have adopted the same standards, which can also be recognized by the CE marking. In these European countries the CE marking and the associated standards is protected (the manufacturers are declaring their conformance to a minimum list of standards). As many of the European standards are converging with international standards, the CE marking will be often present on products manufactured and sold outside of Europe (notably in Asia that exports lots of manufactured products to Europe).

Declaration of conformity-CE Certification
The CE marking is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. To permit the use of a CE mark on a product, proof that the item meets the relevant requirements must be documented. Sometimes this is achieved using an external test house which evaluates the product and its documentation. Often it is achieved by a company-internal self-certification process. In any case the responsible organization (manufacturer, representative, importer) has to issue a EC-Declaration of Conformity (EC-DoC) indicating its identity (location, etc.), the list of European Directives it is declaring compliance with, a list of standards the product complies with, and a legally binding signature on behalf of the organization. The EC-DoC underlines the sole responsibility of the manufacturer. When parts of the certification process for the CE marking are performed by 3rd party test houses or certification bodies then it is mandatory that the CE symbol also includes a number identifying the 'Notified Body'.

To be strictly accurate, there are two forms of Declaration, either a "Declaration of Conformity" or a "Declaration of Incorporation". Generally speaking this is only the case under the Machinery Directive. For example, a stand-alone machine that requires only a power source to operate would be issued with a Declaration of Conformity; whereas a machine that requires additional systems, attachments, feed conveyors etc, before it can provide its intended function must be issued with a Declaration of Incorporation. In this latter case, it is illegal to CE Mark such a machine. This can only be implemented once the machine has been finally installed and all other elements incorporated into the system. A final risk assessment is performed to verify compliance of the system and a final Declaration of Conformity is then issued.

Furthermore, these directives are based upon what the European Commission calls a New Approach, whereby if any of the Article 100A Directives apply to a product, then they must be followed. There are multiple classes of CE marking. A CE mark of 1 is easily attainable and does not require toxicology studies, while a class 3 CE mark is the most difficult to obtain and which comes with well documented toxicology evaluations.

Directives providing the requirements for the CE marking are created by the European Union (EU), but the markings are required throughout the European Economic Area (EEA). According to information provided by the Swiss Government for Swiss Exporters the CE Mark is not compulsory in Switzerland except for products for export to the European Union.)

The CE Certification process

Step 1: Identify the Directive(s) that are applicable to your product. You can download these directives free of charge from the European Union weLEOte

Step 2: Identify the conformity assessment procedure that must be taken. This could be self-declaration, involve testing, inspection or quality system assessment from a Notified Body or a combination of these. The conformity assessment procedure will differ depending on your product and the Directive in respect of which you will be CE marking. If you are unsure about which procedure to take, please contact us for advice.

Step 3: Determine the dates by which you must take action. This will be the date that the Directive comes into force. The majority of directives are already in force. In these cases, it is an offence to place a product on the market without CE marking because it indicates a presumption of conformity with all relevant Legislation.

Step 4: Identify if there are any Harmonised European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption that conformity to these standards will give conformity with the relevant part of the Directive. Whenever possible or appropriate, manufacturers should follow harmonised standards.

Step 5: Ensure the product complies with all the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.

Step 6: Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. This will be stated in the directive and is dependent upon the product you are CE marking. You must not affix CE marking to your product until all necessary certifications have been obtained from the Notified Body.

Step 7: Maintain Technical Documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. It is essential to retain this documentation.

Step 8: Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request.

Step 9: Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements.

Step 10: Affix CE marking on your product and/or its packaging and accompanying literature as stated in the directive.

For further information about the CE certification process, please contact us.  

As a Notified Body for 17 Directives, LEO Product Services offers one of the most comprehensive certification services in the world.

•Active Implantable Medical Devices (AIMD) - 90/385/EEC
•Medical Devices (MDD) - 93/42/EEC
•Construction Products (CPD) - 89/106/EEC
•Efficiency of Liquid or Gaseous Fuelled Hot Water Boilers - 92/42/EEC
•Electromagnetic Compatibility (EMC) - 89/336/EEC
•Equipment in Potentially Explosive Atmospheres  (ATEX) - 94/9/EC  
•Gas Appliances - 90/396/EEC
•Lifts - 95/16/EC
•Low Voltage Equipment (LVD) -  2006/95/EC
•Machinery - 98/37/EC
•Marine Equipment (MED) - 96/98/EC 
•Noise Emission in the environment by equipment for use outdoors - 2000/14/EC
•Non-automatic Weighing Instruments - 90/384/EEC
•Personal Protective Equipment (PPE) - 89/686/EEC
•Pressure Equipment (PED) - 97/23/EC
•Radio and Telecommunications Terminal Equipment - 1999/5/EC
•Transportable Pressure Equipment Directive - 99/36/EC

LEO can also offer Notified Body Services for the In Vitro Diagnostic Medical Devices Directive - 98/79/EC, through a partner.

 Other European directives, which LEO is not a Notified Body for:

•Cableway Installations for Passengers - 2000/9/EC
•Energy Efficiency: Household Refrigerators & Freezers - 96/57/EC
•Explosives for Civil Uses - 93/15/EEC
•Packaging and Packaging Waster - 94/62/EC
•Recreational Craft - 94/25/EC
•Simple Pressure Vessels - 87/404/EEC
•Toys - 88/378/EEC
For further information about EU directives, please contact us.

These are The LEO Certification Testing Center to provide you with The certification of dynamic information, if you want to apply for The certification, please call: +86 0512-62370399 or to your product information and certification requirements sent to the email : sdb@leocorp.cn, LEO will be to answer your questions. .