Generally, the CE certification is a mandatory certification in the EU. The EU market has specific regulations. All products exported to the EU must obtain CE certification. The CE certification serves as a pass for products to enter the EU market and is a must-have. Without it, products will not be able to clear customs and sold in the EU market.
The EU has established different regulations (directives) for various products, such as children's toys, low-voltage electrical appliances, personal protective equipment, and instruments, each with its corresponding regulations (directives). These EU regulations (directives) outline the basic quality and safety requirements for the respective products, as well as the procedures for market entry and qualification assessment.
CE Directive Overview:
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 Medical Device Directive (AIMD) - 90/385/EEC
In Vitro Diagnostic Medical Devices Directive (INVMD) - 98/79/EC
Machine Directive (MD) - 2006/42/EC
Limitation of the Use of Certain Hazardous Substances (RoHS) - 2011/65/EU
WEEE Directive - 2012/19/EU
Battery Directive (BATTERY) - 2006/66/EC
Explosive Atmospheres Equipment (ATEX) - 2014/34/EU
Energy-related products EcoDesign requirements (ECODESIGN) - 2009/125/EC
Energy-Related Products Labelling Regulation (LERP) - 2010/30/EU
Packaging and Packaging Waste Directive (Waste) - 2015/720
General Product Safety Directive (GPSD) - 2001/95/EC
Personal Protective Equipment (PPE) Directive - 2016/425/EU
Toy Safety Directive (TOY) - 2009/48/EC
Regulation on Civil Explosives (ECU) - 2014/28/EU
Fireworks Products Directive (PTA) - 2013/29/EU
Measurement Instrument Directive (MID) - 2014/32/EU
Non-Automatic Weighing Instruments Directive (NAWI) - 2014/31/EU
Cableway Installation Specification (CWI) - 2016/424
Lifts and Lift Safety Components Directive (LIFTS) - 2014/33/EU
Simple Pressure Vessel Directive (SPVD) - 2014/29/EU
The process for manufacturers to self-declare and affix the CE mark to their products: Manufacturers must ensure their products comply with EU regulations, are safe and effective, establish relevant technical documents, sign a conformity declaration, and register with the competent authorities of the member states before they can affix the CE mark to their products and sell them in the EU.
