I. Applicable Directives
Determining applicable directives: Based on EU regulatory practice, the directives are identified as follows: Machinery Directive (MD) 2006/42/EC (mandatory for mechanical products with power systems—such as the mechanical structure/safety guarding of machinery and non-standard automated assembly lines; note that this was superseded by the new Regulation 2023/1230 in January 2023, with a transition period allowing the use of the current directive until January 20, 2027);
Low Voltage Directive (LVD) 2014/35/EU (governs electrical safety for equipment operating at 50–1000V AC or 75–1500V DC; requires testing for leakage current, insulation, withstand voltage, temperature rise, and earth continuity, as well as cabinet protection ratings of IP55 or higher and triple-layer overload protection); Electromagnetic Compatibility Directive (EMC) 2014/30/EU (ensures equipment does not interfere with nearby appliances and meets standards for both immunity and low emissions; testing covers radiated/conducted emissions, electrostatic immunity, and conducted interference; separation of high- and low-voltage circuits is a key design factor); Combined Certification—most machinery requires a “three-in-one” CE certification covering MD, LVD, and EMC (processed simultaneously), as integrated certification across multiple directives has become the norm for complex equipment (e.g., an automated assembly line must comply with MD for mechanical safety, LVD for electrical safety, and EMC for interference/immunity)—specifically for non-standard assembly lines, the three directives (MD, LVD, and EMC) must be processed together to obtain certification.
II.
Application Process
The application process steps are as follows.
Based on industry-standard certification practices, the process unfolds as follows: Assessment—submission of product details for a quote (the initial step in the “Maoyiqitong” process, requiring mechanical schematics, circuit diagrams, and BOM lists); Application—completion of the CE certification application form and submission of required data (model specifications, parameters, and intended use); Testing—on-site product testing and review (prototype testing/assessment and on-site inspection; for TÜV Rheinland certification: document review, prototype assessment, and on-site inspection; type testing to obtain the test report); Rectification—product and documentation adjustments for general machinery, or on-site review by foreign engineers for high-risk machinery (safety protection function testing, electrical safety checks, and on-site audit requirements); Review—submission of materials for overseas review (comprehensive evaluation based on document review results and test/assessment reports); Certification—issuance of the certificate by a Notified Body (NB) (e.g., TÜV Rheinland, SGS, etc.). The six-step process—assessment and quotation, application, prototype testing, rectification and review, overseas review, and NB certification—culminates in obtaining the certificate.
III.
Risk Assessment Documentation
What to look for in risk assessment and technical documentation.
Regarding machinery safety practices, the documentation process is as follows: Risk Assessment—conducted in accordance with EN ISO 12100 (covering basic design principles and risk assessment methodology, hazard identification, risk estimation and evaluation, and hazard elimination or adequate risk reduction); identification of applicable harmonized standards (e.g., EN ISO 12100 for risk assessment, EN ISO 13850 for emergency stops, EN ISO 12100 for noise testing, and standards for safety guards/protective enclosures); Technical Construction File (TCF)—including mechanical structural drawings, circuit diagrams, risk assessment reports, user manuals, CE certificates for critical components (e.g., the “three-piece set” of technical documents, circuit diagrams, and test reports for film blowing machines), design drawings, and test reports (following the Huayu testing process); Testing—laboratory type testing (covering leakage current, insulation, withstand voltage, temperature rise, earth continuity, radiated and conducted emissions, electrostatic discharge immunity, and conducted interference) and obtaining test reports; Rectification—addressing non-compliance through design or material adjustments (e.g., adding safety guards, safety circuits, or emergency stop devices)—and finally, the “four-piece set” of risk assessment documentation: EN ISO 12100 risk assessment, TCF technical documentation (structural drawings, circuit diagrams, manuals), type test reports, and rectification records;
approval is granted only when this complete set of four documents is in order.
IV. Declaration and Marking
What to look for regarding the Declaration of Conformity and the CE mark.
Based on EU practice, the marking process involves the following: Declaration of Conformity (DoC)—an EC Declaration of Conformity (must include the manufacturer’s or authorized representative’s full name and address; product identification such as model, serial, and batch numbers; applicable EU directives/regulations like the Machinery Directive, Low Voltage Directive, and EMC Directive; the Notified Body identification number; a legally binding signature; documentation in English or the official language(s) of the target EU member state(s); and retention for at least 10 years as proof of compliance); Signing—low-risk machinery can be self-certified by the manufacturer, while medium- to high-risk machinery requires signing based on a Notified Body’s inspection report (retain the signed/stamped document); CE Marking—clear and permanent marking on the equipment itself and its packaging (font size ≥ 5mm; screen printing or etching recommended; adhesive labels are not accepted), with the Notified Body code added for medium- to high-risk machinery; Archiving—finalizing and retaining technical documentation (accessible to EU market surveillance authorities at any time). The marking and declaration process comprises three steps: signing the DoC (including the Notified Body number), applying the CE mark (clear, permanent screen printing or etching), and archiving records for 10 years;
completing these three steps closes the compliance loop.
V. Risk Classification and Selection of Notified Body
Determining risk classification and selecting the appropriate Notified Body.
Based on industry certification practices, the selection process is as follows: Risk Classification—ordinary machinery undergoes self-declaration (self-certification) via internal production control procedures, while hazardous machinery requires certification by a Notified Body (high-risk machinery listed in Annex IV—such as injection molding machines, presses, and film blowing machines—requires Notified Body involvement, including type testing, factory inspections, safety function testing, electrical safety testing, and on-site audits); Organizations—third-party testing and certification bodies (e.g., TÜV Rheinland, SGS, UL, Shifu Testing, Huayu Testing, Xunke Standards) and Notified Bodies (which issue certificates and conduct on-site reviews by foreign engineers); Costs and Timelines—determined by machinery complexity (starting from tens of thousands of RMB for ordinary machinery; higher for high-risk machinery) and a duration ranging from 20 days to several weeks (strategy for obtaining certification for film blowing machines in 20 days: technical documentation, circuit diagrams, test reports, Declaration of Conformity, CE marking, EU manuals; quote and assessment come first); Materials—prepare technical documentation first (mechanical structure diagrams, circuit diagrams, risk assessment reports, user manuals, CE certificates for critical components)—Risk Classification involves three key aspects: self-declaration for ordinary machinery, NB involvement for high-risk machinery, and a timeline starting from 20 days, with classification based on the Annex IV list.
Conclusion
How do you obtain CE certification for non-standard assembly lines?
The conclusion is a five-step process: Directives, Procedures, Documentation, Marking, and Classification.
Directives—A “three-in-one” approach covering the Machinery Directive (MD) 2006/42/EC (safety guarding; transition to 2023/1230 by Jan 2027), Low Voltage Directive (LVD) 2014/35/EU (electrical safety for 50–1000V; IP55 cabinet rating), and Electromagnetic Compatibility (EMC) Directive 2014/30/EU (interference immunity, low emissions, and separation of high/low voltage circuits); Process—Quotation, application submission, prototype testing (document review, prototype assessment, and on-site inspection), rectification (standard fixes vs. on-site review by foreign engineers for high-risk cases), overseas review, and certification by a Notified Body (NB); Documentation—EN ISO 12100 risk assessment, TCF technical file (structural drawings, circuit diagrams, manuals, test reports, CE certificates for critical components), type-test reports, and rectification records; Marking—Declaration of Conformity (DoC) (manufacturer details, product ID, regulations, NB number, signature, 10-year retention) and CE labeling (font size ≥5mm; screen printing or etching; NB code required for medium-to-high risk products); Classification—Self-declaration for standard machinery vs. NB type-testing and factory inspection for high-risk machinery under Annex IV (e.g., injection molding machines, presses, blown film machines);
timeline starts at 20 days, with costs based on complexity.
In short, the CE process follows this formula: three directives, a six-step workflow, a four-part document set, and appropriate classification/agency selection—clear these four hurdles, and the CE mark is secured.
