The “CE” mark is now mandatory for a wide range of products sold in the European Union. 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. The CE mark is described by the European Commission as a “passport” that allows manufacturers to trade industrial products freely within the internal market of the EU.
Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. A manufacturer who has gone through the conformity assessment process, may affix the CE mark to the product. The CE mark is not a quality mark and does not indicate conformity to a standard; rather it indicates conformity to the legal requirements of the EU directives. CE marking now provides a product access to 32 countries with several other nations also requiring conformance to EU product safety, health, and environment legal mandates.
Because there is no comprehensive list of the products that require CE marking, it is the manufacturer's responsibility to determine if their product requires a CE mark. 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.
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
On the other hand, the following are 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. 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.
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.
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. 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.
Retrieved 02/13/2014 from Export.gov: CE Marking - Program Overview