Mechanical CE certification is a mandatory safety compliance certification for mechanical products to enter the EU market. The core basis is the EU 2006/42/EC Machinery Directive (MD Directive). After passing the certification, a CE mark is affixed, allowing the product to freely circulate within the EU and the European Economic Area (EEA). It is the "entry permit" for products to enter the European market. 

Core regulations and scope of application

Core directives and standards

Basic directive: 2006/42/EC Machinery Directive (MD), covering health and safety requirements throughout the entire process of mechanical design, manufacturing, and use, applicable to single machines, interchangeable equipment, safety components, semi-finished machinery, etc. 

Related instructions: Electrical mechanical equipment must simultaneously comply with the Low Voltage Directive (LVD 2014/35/EU), the Electromagnetic Compatibility Directive (EMC 2004/108/EC); explosion-proof scenarios must comply with the ATEX Directive (2014/34/EU). 

Core General Standard: EN ISO 12100:2023 (to be mandatory from January 1, 2026, replacing the previous version), stipulates the general principles for mechanical safety risk assessment and risk reduction, and adds safety requirements for human-machine collaboration and AI-controlled machinery. 

Priority level: Class C (specific product-specific standards, such as EN 12415 for machine tools) > Class B (general safety components standards, such as guards and interlock devices) > Class A (basic standards applicable to all categories), with Class C having the highest authority. 

New regulation update: The EU 2023/1230 Machinery Directive will officially replace the 2006/42/EC Directive on January 20, 2027. During the transition period, enterprises need to gradually adapt to the new requirements, including full life cycle risk assessment, product unique identification code (UDI) traceability, etc.