CE Marking – Program Overview
The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. For a list of countries that require the CE marking, see: CE Marking Countries. A manufacturer who has gone through the conformity assessment process, may affix the CE marking to the product. With the CE marking, the product may be marketed throughout the EU. CE marking now provides product access to 32 countries with a population of nearly 500 million.
Unfortunately, there is no comprehensive list of the products that require a CE marking. Therefore, it is the manufacturer's responsibility to determine if a product requires a CE marking. The "New Approach Directives" are documents that contain the legislation issued by the European Commission on the requirements that need to be met and procedures that must be followed in order for a particular product to be CE marked for sales in the EU.
In order to determine if your product needs a CE marking, you should look in each directive that you judge as related to your product. Our Guide to navigating the CE marking process is organized by directives: CE Marking Guide. Under each directive, we explain the route to CE marking certification step-by-step and in one place.
Some products require conformance to more than one directive. For example, the Safety of Machinery directive, the Electromagnetic Compatibility (EMC) directive, and the Low Voltage Equipment directive may all apply to one product.
Many of the CE marking directives allow manufacturers to self-certify their products.
Some examples for which manufacturers can self-certify include:
· Safety of Machinery Directive
· Electromagnetic Compatibility (EMC) Directive
· Low Voltage Directive
· Class I products of the Medical Device Directive
· Most products covered by the Radio and Telecommunications Terminal Equipment (R&TTE) Directive
Some examples of the directives that do not allow manufacturers to self-certify include:
· Simple Pressure Vessels Directive
· Appliances Burning Gaseous Fuels Directive
· Most products covered by the Pressure Equipment Directive
· Most products covered by the Equipment and Protective Systems in Potentially Explosive Atmospheres Directive
If you are not permitted to self-certify your product, you will need to employ the services of a testing laboratory that is affiliated with a "European Notified Body" to test and certify your product for the CE marking. There are labs in the U.S. that subcontract for European notified bodies and are qualified to do the testing and certifying. We have provided a list of labs, including labs affiliated with notified bodies as well as labs that are not authorized with a notified body, but which are independent labs and can test that a product covered by a non-regulated directive (such as the EMC or Low Voltage Directives), has met a European standard: Testing/Certifying Labs.
If you are permitted to self-certify your product, you may need to order the standards that apply to your product, particularly in the case of the Low Voltage and EMC Directives. We have provided sources for ordering standards and for locating CE Marking consultancy services: Consultants/Ordering Standards.
Once the manufacturer has conformed to the requirements laid out in the applicable directive(s), whether through self-certification or approval by a notified body, and has obtained a certificate/report from a lab to prove conformance, the manufacturer needs to affix the CE marking to its product. The manufacturer must also include a "declaration of conformity" with each shipment stating which CE marking directive(s) has been met and include a signature of a company official indicating the company's responsibility for its CE marking compliance claim. We have provided an example of a declaration of conformity: Declaration of Conformity.
The exporter must maintain a file called a "technical file" containing the paperwork that proves conformity to the CE marking directive(s) covering its product. The exporter or authorized representative must be able to provide the supporting paperwork to prove CE marking conformity at any time, if requested by the appropriate member state authorities. See: Technical File Procedures for a framework for compiling a technical file.
Finally, it is the manufacturer/exporter's responsibility to regularly check for and comply with any standards changes that might affect its product. Therefore, it is important to periodically visit the EU website http://www.newapproach.org that lists the CE marking directives and their standards.
For additional information on the CE marking process, see the National Institute of Standards and Technology (NIST) publication "TO U.S. MANUFACTURERS: ALERT PRODUCT "MARK" REQUIRED FOR U.S. EXPORTS TO EUROPE!"