1、 The Legal Status of CE Certification
CE certification is a mandatory entry threshold for laser marking machines into the EU market. Without a CE certificate and a CE mark, products
cannot freely circulate in the European Economic Area (EEA). After the full implementation of the new version of the EU General Product Safety
Directive in 2026, the inspection rate of customs for uncertified or non standardized products has significantly increased, and compliance has
become a prerequisite for obtaining orders.
2、 Main EU directives involved
Laser marking machines belong to high-risk industrial equipment and usually need to meet the following instructions simultaneously:
Machinery Directive (MD) 2006/42/EC: Safety design requirements for structures containing mechanical components or moving parts will be
replaced by Machinery Regulation (EU) 2023/1230 on January 20, 2027
Low Voltage Directive (LVD) 2014/35/EU: Applicable to electrical equipment with rated voltage of 50V~1000V AC or 75V~1500V DC
Electromagnetic Compatibility Directive (EMC) 2014/30/EU: requires equipment to not generate excessive electromagnetic interference and
to have sufficient anti-interference capability
RoHS Directive 2011/65/EU: Restrictions on the Use of Hazardous Substances such as Lead, Mercury, Cadmium, etc
Laser Product Safety Directive: Specific Implementation through EN 60825 Series Standards
3、 Core testing standards
The CE certification of laser marking machines shall comply with the following coordinated standards:
EN 60825-1 (Laser Product Safety Part 1: Equipment Classification, Requirements, and User Guidelines): The core standard classifies lasers into
Class 1 to Class 4 levels based on wavelength, output power, and pulse characteristics. Industrial laser marking machines usually belong to Class 4
(high power), and direct or diffuse reflected light may cause serious harm to human eyes and skin
EN ISO 12100 (Principles and Risk Assessment for Mechanical Safety Design): General Standard for Mechanical Safety Design
EN 60204-1 (Safety Requirements for Mechanical and Electrical Systems): General Requirements for Electrical Safety
EN 11553 (Basic Requirements for Laser Processing Equipment): Special Safety Requirements for Laser Processing Equipment
EN 60825-4 (Laser Protection Devices): Requirements for Laser Protection Systems
EMC related standards: EN 55032, EN 55035, EN 61000 series, etc
EN ISO 21254 series: Laser damage threshold testing, evaluating the tolerance of optical components under laser irradiation
4、 Special precautions for the new regulations in 2026
Single fault analysis requirement: Even for devices with a nominal Class 1 rating, if intelligent functions such as facial recognition or driver monitoring
are involved, single fault analysis must be conducted to ensure that the radiation limit that the human eye can withstand still meets the standard under
extreme conditions such as hardware failure
Full lifecycle compliance: EU regulation has been upgraded from simple "sample testing" to "full lifecycle compliance", and technical documents must
be kept for at least 10 years
Normalization of market spot checks: Even if the CE mark has been affixed, products may still be randomly checked, and technical documents must be
available for reference at all times
5、 Certification process
Step 1: Project Evaluation and Data Preparation
Submit an application form, providing product specifications (including laser wavelength and power), circuit diagrams, laser path diagrams, laser head
specifications, key component lists, and BOM tables
Step 2: Sample testing
Send the complete prototype to a laboratory with ISO/IEC 17025 qualifications for laser radiation measurement, beam divergence angle determination,
safety interlock device functional verification, and label durability testing
Step 3: Preparation of Technical Documents
Based on test data, issue a laser safety level report to determine the final product category
Step 4: Rectification and retesting (if necessary)
If the initial test fails (common issues such as insufficient attenuation of the protective cover), rectification is required before retesting
Step 5: Sign the Declaration of Conformity (DoC)
The manufacturer or authorized representative signs the EC conformity declaration to confirm that the product complies with relevant directives and
standards
Step 6: Attach CE mark
Legally affix the CE mark on the product body and packaging
Cycle: In the case of complete data and passing the test in one go, the regular cycle is 1-3 weeks; For high-power ultraviolet/picosecond laser
equipment or those that require rectification and verification, the cycle may be extended to 3-5 weeks
6、 List of Technical Documents
Product model list, high-definition appearance photos (including internal structure diagram), explosion diagram, assembly diagram
Multi language instruction manual (must include safety operation instructions)
Circuit schematic, PCB layout, laser path diagram
List of key components (including laser source specifications, specifying wavelength and power range)
Laser label electronic file (warning label, instruction label)
Risk assessment report (based on EN ISO 12100)
Full test report (electrical safety, EMC, laser radiation, etc.) RoHS）
EC Declaration of Conformity (DoC)
EU authorized representative information (non EU companies must specify)
Production and Quality Control Records
7、 Compliance risks and precautions
Beware of false certificates: There are cases in the market where CE certificates are issued without actual testing, and such certificates are invalid
in customs inspections or market supervision, and may even lead to product seizure or recall
Timeliness of standards: Using expired standards will result in the invalidation of the CE mark, and it is necessary to ensure the use of the latest
version of the standard (such as IEC 60825-1:2026)
EU Authorized Representative: Non EU manufacturers must designate an authorized representative within the EU to manage CE certification related
matters and document archiving
Sample quantity: Usually 1-2 complete test prototypes are required; It is recommended to prepare 10 samples for the laser light source section to
verify the accuracy of data such as luminous flux maintenance rate
