Certification Introduction
For robots exported to the European Union (EU) and placed on the EU market, CE certification is a mandatory unified market access requirement that covers all EU member states, and regulatory requirements of all member states follow the EU's unified framework. Robots with AI functions must additionally meet the classification and compliance requirements of the EU AI Act, and can only enter circulation in the EU market after achieving compliance and affixing the CE marking.
Laws and Regulations
Core applicable regulations:
- Machinery Directive (2006/42/EC): The basic compliance framework for all industrial and service robots
- Additional directives: The Low Voltage Directive 2014/35/EU and Electromagnetic Compatibility Directive 2014/30/EU apply based on product functions; robots used in explosive environments must comply with the ATEX Directive
- New requirements effective 2026: AI-powered robots must meet 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 satisfied Regulatory requirements are uniformly coordinated at the EU level, with each member state responsible for market supervision and implementation, and there are no essential differences between member states.
Technical Requirements
- Core safety standards: General machinery safety EN ISO 12100:2023 (mandatory from January 1, 2026), dedicated standards for industrial robots EN ISO 10218-1/2, collaborative robots must 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 protection requirements: Meet the repairability and recyclability requirements for ecodesign, provide carbon footprint accounting (ISO 14067), and provide proof of recycled material proportion for battery-equipped products
- Full life cycle risk assessment is mandatory, and technical documents must be retained within EU territory for 10 years.
Certification Process
- Complete risk identification and assessment in the product design phase, and implement risk reduction measures
- Complete product testing in accordance with applicable standards, and prepare structured electronic technical documents
- Select the conformity assessment path based on product risk level: Low and medium-risk robots can complete the Declaration of Conformity by the manufacturer; high-risk robots require intervention from 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 requires regular update every 5 years
WANVE, as a professional technical service organization, provides one-stop full compliance support for enterprise export.