Certification Introduction

For robots exported to the European Union and placed on the market, CE certification is a mandatory unified market access requirement covering all EU member states, and regulatory requirements of all member states follow the EU's unified framework. Robots with AI functions need to additionally meet the classification and compliance requirements of the EU AI Act, and can only enter and circulate in the EU market after compliance and affixing the CE marking.

Laws and Regulations

Core Applicable Regulations: 1.Machinery Directive (2006/42/EC): The basic compliance framework for all industrial and service robots. 2.Additional Directives: Depending on product functions, the Low Voltage Directive 2014/35/EU and Electromagnetic Compatibility Directive 2014/30/EU are additionally applicable; robots used in explosive environments must comply with the ATEX Directive. New requirements from 2026: AI-powered robots must comply with the compliance requirements of the EU AI Act; robots with built-in batteries must comply with the new Battery Regulation (BMR); relevant requirements of the Carbon Border Adjustment Mechanism (CBAM) must be aligned with. Regulatory requirements are uniformly coordinated at the EU level, and each member state is responsible for market supervision and implementation, with no essential differences.

Technical Requirements

Core Safety Standards: General machinery safety EN ISO 12100:2023 (mandatory from January 1, 2026), special standard for industrial robots EN ISO 10218-1/2, collaborative robots additionally meet ISO/TS 15066 Other General Requirements: Control system safety complies with EN ISO 13849-1, electrical safety complies with EN 60204-1, networked intelligent robots meet the cybersecurity standard EN 303 645 Environmental Requirements: Meet the repairability and recyclability requirements of ecodesign, provide carbon footprint accounting (ISO 14067), and provide proof of recycled material content for battery-equipped products It is mandatory to complete a full life cycle risk assessment, and technical documents must be retained in the EU territory for 10 years.

Certification Process

Complete risk identification and assessment at the product design stage, and implement risk reduction measures;

Complete product testing in accordance with applicable standards and prepare structured electronic technical documents;

Select the assessment path according to the product risk level: low and medium risk robots can complete the self-declaration of conformity by the manufacturer; high risk robots require intervention by an EU Notified Body to complete type inspection and production compliance audit;

Sign the EU Declaration of Conformity, affix the CE marking to the product, and CE certification needs to be regularly updated every 5 years.

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