5. Complementation of your technical construction file
6. Draw up directions for use
7. Draw up declaration of conformity
8. Affixing of the CE-marking
Step 1. Which directives / standards apply?
There are a number of directives installed for groups of products. A producer, by using CE-marking, gives a promise to market safe products and provide relevant information about risks and precautions. This research focuses on the three most apparent directives in industry settings: Machinery Directive (MD) 2006/42/EC, Low Voltage Directive (LVD) 2014/35/EU, Electromagnetic Compatibility (EMC) directive 2014/30/EU. On a voluntary basis certain norms can be applied to prove conformity with these directives. There is a long list of norms.
Which directives (required) will apply to your product?
Machine Directive (MD) 2006/42/EC
► Does your product fall within the scope or is it excluded, as described in article 1 and 2? Low Voltage Directive (LVD) 2014/35/EU
Applies to all electrical equipment intended for a nominal AC voltage between 50 V and 1000 V and a nominal direct current between 75 V and 1500 V, with the exception of the material and the phenomena included in annex II. Electromagnetic Compatibility (EMC) directive 2014/30/EU
Does your product fall within the scope, as described in article 2 (definitions) or is it excluded, as descriped in article 1?
Step 2. Execute conformity assessment:
In each directive a procedure is included for a conformity assessment, often captured in a flowchart. The complete CE-process is made up of modules, from module A, internal production control, until module H, full quality assurance by a notified body. Dependent on the type of product and the safety risks, a certain module has to be followed (modules A, BC, BD, BE, BF, G, H). Along with this choice, an assessment is made whether a notified body is necessary or not, or maybe recommendable, to use.
Step 3. Apply safety requirements:
In the applicable directives the minimal essential safety requirements are given. The applicable essential safety requirements should be processed in a risk-analysis (template).
Step 4. Execute risk analysis:
To assess which risks can arise and whether the safety requirements will be met, a risk analysis should be conducted. See Step 3.
Step 5. Complementation of Technical Construction File (TCF):
Each applicable directive contains the criteria that have to be attended in the TCF.
Annex VII of the Machinery Directive explains which elements your Technical Construction File should contain.
Step 6. Draw up directions for use:
Criteria that have to be addressed in the directions for use:
MD (Machine Directive): Appendix I, essential safety requirement 126.96.36.199.
Step 7. Draw up declaration of conformity:
For each applicable directive the elements that have to be attended in the declaration of conformity are included. With a declaration of conformity a manufacturer states that a product is in conformity with the applicable directives and thus with European safety legislation.
► MD (Machine Directive): Appendix II, Paragraph 1A.
► LVD (Low Voltage Directive): Appendix III, Paragraph B.
► EMC (Electro Magnetic Compatibility): Appendix IV, Paragraph 2.
Step 8. Affixing of the CE marking:
If all steps are completed, CE-marking can be affixed to a product. The official CE-mark (mandatory shape) has to be affixed, see Machine Directive, appendix III.
When these eight steps are carefully executed, a product should comply with the Legal requirements and the CE mark can be legitimately affixed. As a result a buyer may expect that the product is conform product safety legislation. The potential risks for using a product should have been assessed and been prevented from occurring or proper warnings should have been issued with the product. So when using a product, unsafe situations must be prevented.
Example of a correct CE-mark:
When the CE marking is reduced or enlarged, the proportions given in the above image have to be maintained.
The components of the CE marking must have approximately the same height, namely minimum 5 mm. The CE marking must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same technique.
All machinery must be marked visibly, legibly and indelibly with the following minimum particulars:
► the business name and full address of the manufacturer and, where applicable, his authorised representative,
► designation of the machinery,
► the CE Marking,
► designation of series or type,
► serial number, if any,
► the year of construction, that is the year in which the manufacturing process is completed.
It is prohibited to pre-date or post-date the machinery when affixing the CE marking.