Overview
The European Union implements a comprehensive regulatory framework that requires products to comply with various directives and regulations before they can be placed on the market. The CE marking indicates that a product meets all applicable EU requirements and can move freely within the European Economic Area. Different product categories are subject to specific directives that outline essential safety, health, and environmental protection requirements.
Required Certifications
CE
Safety, EMC, Radio, etc.
The CE (Conformité Européenne) mark indicates that a product complies with all applicable EU directives and regulations. Depending on the product category and applicable directives, certification can be performed through self-declaration (for lower-risk products) or may require Notified Body involvement (for higher-risk products). Common directives include the Low Voltage Directive (LVD) for electrical safety, Electromagnetic Compatibility Directive (EMC), Radio Equipment Directive (RED), Machinery Directive, and Restriction of Hazardous Substances (RoHS) Directive. Technical documentation must be maintained, and an EU-based authorized representative is required for manufacturers outside the EU.
Mandatory
Yes
Follow-up Inspections
Not Required
Validity Period
N/A
Mark Required
Yes
Local Representative
Required
RED
Radio Equipment
The Radio Equipment Directive (RED) applies to products that intentionally transmit or receive radio waves for communication or radiodetermination. This includes wireless devices, IoT products, mobile phones, and more. Compliance involves demonstrating that the equipment meets essential requirements for safety, EMC, and efficient use of radio spectrum. For most radio equipment, Notified Body involvement is required to assess conformity with the directive.
Mandatory
Yes
Follow-up Inspections
Not Required
Validity Period
N/A
Mark Required
Yes
Local Representative
Required
RoHS
Environmental
The Restriction of Hazardous Substances (RoHS) Directive restricts the use of certain hazardous substances in electrical and electronic equipment. Products must not contain more than the maximum permitted concentrations of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and certain phthalates. Compliance involves material testing, documentation, and ensuring the supply chain meets requirements.
Mandatory
Yes
Follow-up Inspections
Not Required
Validity Period
N/A
Mark Required
No
Local Representative
Required
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