Should the EC Declaration of Conformity be replaced by the CE Declaration of Conformity?
The Machinery Directive uses two abbreviations: CE certification and EC Declaration of Conformity. Nowadays, people more commonly use the terms CE certification or CE marking, while EC simply stands for Declaration of Conformity. Products covered by the Machinery Directive must first complete an EC Declaration of Conformity before they can bear the CE marking.
Steps to complete CE certification
Product Classification
The following points should be noted when classifying products:
Is the product covered by the Machinery Directive?
Does this product fall under the scope of Annex IV of the Machinery Directive? The machinery products listed in Annex IV are usually of the "particularly dangerous" category, such as presses, woodworking machinery, and freight elevators. In the absence of corresponding harmonized standards, these products must undergo EC type testing or full quality assurance.
Is this product a subsystem or a semi-finished machine?
For example, if a robot is considered a semi-finished product, the manufacturer must issue a combination statement according to Appendix II B; simultaneously, the manufacturer must conduct a risk assessment of the semi-finished machine according to Appendix VI and provide an assembly manual. The manufacturer's combination statement prohibits the use of subsystems or semi-finished machines independently;
Is this product a safety-related component?
Annex V of the Machinery Directive is a list of safety-related components, and all safety-related components must undergo CE certification.
Confirm any other applicable additional instructions
If a machine also complies with other EU directives (which include CE certification as well as other requirements), it should be ensured that it meets the requirements of the other directives before obtaining CE certification. For example, if a machine contains electrical equipment, it should also comply with the Low Voltage Directive and the EMC (Electromagnetic Compatibility) Directive.
Ensure that safety rules are met
Under Annex I of the Machinery Directive, machine manufacturers are obligated to comply with basic health and safety requirements. While Annex I requirements are relatively abstract, more detailed guidance can be obtained from other relevant EU product standards.
Execute risk assessment process
Depending on the intended use, when a machine is first put on the market, all relevant hazards throughout the machine's lifecycle must be identified, including the hazards faced by all different groups who may come into contact with the machine, such as operators, cleaners, or maintenance workers.
For each hazard, a risk assessment and judgment are conducted. Then, based on standards and current technological levels, risk reduction measures are developed until the residual risk is reduced to an acceptable range, meeting safety level requirements.
The EN ISO 12100 standard provides a general procedure for risk assessment.
verify
Validation refers to checking and verifying the actual application to ensure that all risk mitigation measures have been fully implemented and that the application is set up and ready for delivery.
For example, for each safety function, verify whether it meets the performance level (PLr) required during the design phase. Performance level verification can be easily performed using Pilz's PAScal tool.
Writing technical documents
According to the requirements of the Machinery Directive, the technical documents specifically include:
Overall mechanical drawings and control circuit diagrams
Complete, detailed drawings (including all calculations, test results, etc., to check that the machine meets basic health and safety requirements).
A list of basic requirements that should be followed in mechanical design, including requirements in directives, standards, and other technical specifications, as well as protective measures to eliminate hazards posed by the machine (generally included in the risk analysis).
Technical reports or certificates, and other reports and test results demonstrating eligibility.
Machine Operation Manual
EC Declaration of Conformity, or a combination declaration with an assembly manual
Declaration of conformity for the machine or parts thereof
Technical documentation does not need to be provided in physical form. However, due to its importance, it must be readily available when needed and provided to the relevant authorities in EU member states within 10 years of the production date.
In the case of mass production, the count starts from the production date of the last machine.
Technical documents must be written by authorized personnel within the EU.
Issue EC Declaration of Conformity
Only manufacturers or authorized representatives can sign the EC Declaration of Conformity.
By issuing this statement, it is implied that the manufacturer has met all the directives applicable to the product.
An authorized representative is a natural or legal person established within the EU, authorized in writing by the manufacturer to perform procedures related to the Machinery Directive on behalf of the manufacturer, either fully or partially. Once the EC Declaration of Conformity is signed, the legal responsibility of the natural or legal person becomes effective.
Affix CE marking
After issuing an EC declaration of conformity, the CE mark can be affixed to the machine.
It is worth noting that the CE marking for a complete machine is significantly different from other CE markings (such as for components). To avoid confusion, it is recommended that the CE marking for a complete machine be affixed to the nameplate, which should also include the manufacturer's name and address.
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