CE certification is the EU's safety certification, a license for products to enter the EU market, and the EU's supervision method for products entering the EU market. Products affixed with the CE mark indicate that the products comply with EU regulations on safety, health, and environmental protection, and can be legally marketed in the 27 EU member states, 4 countries in the European Free Trade Zone, as well as the UK and Turkey.

According to EU regulations, different products use different evaluation methods to affix the CE mark. There are mainly two ways: most products can be affixed with the CE mark if the manufacturer adopts the self-declaration method; some products with relatively higher risks The CE mark can only be affixed after a conformity assessment by a third-party agency authorized by the EU, that is, a Notified Body.

The EU has formulated different regulations (directives) for different products, such as children's toys, low-voltage electrical appliances, personal protective equipment, medical devices, etc., all have corresponding regulations (directives). EU regulations (directives) stipulate the basic requirements for the quality and safety of the corresponding products, as well as the listing process and conformity assessment procedures.

CE directive introduction:

Radio Equipment Directive (RED) - 2014/53/EU

Low Voltage Directive (LVD) - 2014/35/EU

Electromagnetic Compatibility Directive (EMC) - 2014/30/EU

Medical Device Directive (MDD) - 2007/47/EC

Active Implantable Devices Directive (AIMD) - 90/385/EEC

In Vitro Diagnostic Medical Devices Directive (INVMD) - 98/79/EC

Machine Directive (MD) - 2006/42/EC

Restriction of the use of certain hazardous substances (RoHS) - 2011/65/EU

Waste Electrical and Electronic Equipment Directive (WEEE) - 2012/19/EU

Battery Directive (BATTERY) - 2006/66/EC

Potentially Explosive Atmosphere Equipment (ATEX) - 2014/34/EU

EcoDesign Requirements for Energy Related Products (ECODESIGN) - 2009/125/EC

Energy-Related Products Labelling Directive (LERP) - 2010/30/EU

Packaging and Packaging Waste Directive (Waste) - 2015/720

General Product Safety Directive (GPSD) - 2001/95/EC

Personal Protective Equipment Directive (PPE) - 2016/425/EU

Toy Safety Directive (TOY) - 2009/48/EC

Directive on Civilian Explosives (ECU) - 2014/28/EU

Pyrotechnic Articles Directive (PTA) - 2013/29/EU

Measuring Instruments Directive (MID) - 2014/32/EU

Non-Automatic Weighing Instruments Directive (NAWI) - 2014/31/EU

Specification for Cableway Installations (CWI) - 2016/424

Lifts and Lift Safety Components Directive (LIFTS) - 2014/33/EU

Simple Pressure Vessel Directive (SPVD) - 2014/29/EU

The process of affixing the CE mark to the product by the manufacturer's self-declaration: The manufacturer must ensure that its products comply with EU regulations, that the products are safe and effective, and establish relevant technical documents, sign the declaration of conformity, and register with the competent authorities of the member states. You can affix the CE mark to the product and enter the EU for sale.

The process of affixing the CE mark to the product after the conformity assessment of the notified body: The product manufacturer applies to the notified body, and the notified body provides the manufacturer with conformity assessment services. If the manufacturer and the product meet the regulatory requirements, the manufacturer will be issued a CE certificate. . The manufacturer signs the declaration of conformity according to the CE certificate, and the product can enter the EU market after affixing the CE mark. The responsibilities of the EU, competent authorities of member states, notified bodies and manufacturers are listed.

European Union (EU): Develops EU regulations (directives) and coordinates the activities of the member states.

Member State Competent Authority (CA): Responsible for the implementation of the corresponding regulations (directives) in the country, authorize the notified body in conjunction with the European Union, supervise the behavior of the notified body, and conduct post-market supervision of the product.

Notified Body (NB): Conduct compliance audit and issue CE certificate.

Manufacturer Manufacturer: Ensure that their products meet the requirements of EU regulations (directives), make self-declarations or apply for conformity assessment of notified bodies, affix CE marks, and be responsible for product quality and safety.