The Seven of CE Marking Explained: Step 7- Affix the CE Mark

Step 7: Affix the CE marking



CE mark characteristics 


The CE mark may be affixed once the EC declaration of conformity has been issued. It’s important that CE marking for the complete machine is clearly distinguishable from any other CE markings, e.g. on components. To avoid confusion with any other markings, it is advisable to affix the CE marking for the complete machine to the
machine type plate, which should also contain the name and address of the manufacturer.

The Seven Steps of CE Marking Explained: Step 6- Issue the Declaration of Conformity

Step 6: Issue the declaration of conformity

By issuing the EC declaration of conformity the manufacturer declares that they have considered all the directives that apply to the product. The person signing an EC declaration of conformity must be authorized to represent their company. This means that the signatory is legally entitled to execute a legal transaction, such as signing the EC declaration of conformity, on account of their job function.

When an authorized employee of the company adds their valid signature to an EC declaration of conformity, they trigger the liability of the natural responsible person and, if applicable, the company as a legal entity.

The declaration may also be signed by an authorized representative, who is established in the EU.

The new Machinery Directive requires the declaration to name the person authorised to compile the technical documentation. This person must be established in the EU.

The Seven Steps of CE Marking Explained: Step 5- Compile The Technical Documentation

Step 5: Compile the technical documentation

In accordance with the Machinery Directive, technical documentation specifically comprises:

• An overall drawing of the machinery and drawings of the control circuits
• Full, detailed drawings (accompanied by any calculation notes, test results, etc.) required to check the conformity of the machinery with the essential health and safety requirements 
• A list of the essential requirements of this directive, standards and other technical specifications used in the design of the machinery, a description of the protective measures implemented to eliminate hazards presented by the machinery (generally covered by the risk analysis)
• Technical reports or certificates; reports or test results showing conformity
• The machine's operating instructions

Under the new Machinery Directive, the following are also required:

• A general machine description
• Declaration of conformity or declaration of incorporation plus the assembly instructions
• Declarations of conformity for the machines or devices incorporated into the machinery

This documentation does not have to be permanently available in material form. However, it must be possible to assemble it and make it available within a period of time commensurate with its importance. It must be retained for at least ten years following the date of manufacture and be available to present to the relevant national authorities. In the case of series manufacture, that period shall start on the date that the last machine is produced.

The Seven Steps of CE Marking Explained: Step 4- Perform the Risk Assessment

Step 4: Perform the Risk Assessment

The manufacturer is obliged to carry out a risk analysis to determine all the hazards associated with his machine. The result of this analysis must then be considered in the design and construction of that machine. The contents and scope of a hazard analysis are not specifi ed in a directive, but standards EN ISO 14121 and EN ISO 12100 describe the general procedure.
All relevant hazards must be identifi ed, based on the intended use – taking into consideration all the lifecycles once the machine is placed on the market. All the various groups who come into contact with the machine, such as operating, cleaning or maintenance staff for example, are also considered.
The risk is assessed and evaluated for each hazard. Risk-reducing measures are established in accordance with the state of the art and in compliance with the standards. The residual risk is assessed at the same time: If it is too high, additional measures are required. This iterative process is continued until the necessary safety is achieved.

The Seven Steps of CE Marking Explained: Step 3- Ensure that Safety Regulations are Met

Step 3: Ensure that safety regulations are met

It is the responsibility of the machine manufacturer to comply with the essential health and safety requirements in accordance with Annex I of the Machinery Directive. The formulation of these requirements is relatively abstract, but specifics are provided through the EU standards.
The EU publishes lists of directives and the related harmonized standards. Application of these standards is voluntary, but compliance does provide presumption of conformity with the regulations. This can substantially reduce the amount of evidence required, and a lot less work is needed to incorporate the risk assessment.