13. May 2022
|
Certificates

CE certification for machines

CE certification for machines, among other things


"The safety requirements that apply in the field of plant, equipment and mechanical engineering are as diverse as the solutions available there."

CE certification reflects conformity with EU directives regarding product safety as well as product liability. Accordingly, CE certification concerns all manufacturers who distribute a product within Germany or the EU and are affected by the CE directives.  In simple terms, the directives refer to the necessary protection directives related to "ensuring the safety of humans, domestic animals and livestock or in relation to goods".

Products subject to labelling mostly belong to the categories below:

  • Toys
  • Safety articles
  • Medical products
  • Machines

In a large number of product segments, the CE directives are uniform throughout Europe due to the harmonisation process. As a result, it can be said that the CE Directives provide guidance for manufacturers on how products should be manufactured safely and that the documentation is fully set out. In addition, CE certification and the resulting compliance with the directives minimise the liability risks of manufacturers. This is because manufacturers, by signing the declaration of conformity, comply with and vouch for all applicable European directives.

CE as a guideline


The CE symbol is not a seal of quality, but the approval of the given guidelines. This is the sole responsibility of the manufacturer, subsequently the manufacturer does not need permission to use the symbol.

However, the manufacturer must be able to demonstrate the following:

  • The conformity of all necessary EU directives
  • Checking whether you are allowed to test your products yourself or whether you need to involve an external body to check them.
  • Be able to provide the necessary technical documentation showing conformity with the directives.
  • Finally, an "EU Declaration of Conformity" must be written, as well as signed

After ensuring the conformity and marking of the product, you, as the manufacturer, must provide the national authorities with all necessary documents.

Assessment of the machinery (conformity)


Before proceeding with the assessment procedure, it is important to clarify whether you, as the manufacturer, can assess your product yourself or whether you need to involve a Notified Body.

The Machinery Directive 2006/42/EC provides for the intervention of a Notified Body if the product to be assessed falls into one of the 23 categories listed in Annex IV and is not in conformity with a harmonised European standard covering all relevant health and safety requirements.

In this case, the manufacturer shall seek the assistance of a notified body. If this is not the case, the manufacturer himself carries out internal checks on the product.

A notified body verifies the conformity of a product by carrying out a conformity assessment. It also ensures that the technical documentation sufficiently demonstrates the conformity of the product. If the notified body is involved in the production control phase, its identification number will be placed after the CE marking.

If the notified body is satisfied that the product conforms, it issues a certificate of conformity to confirm this. The manufacturer then issues the declaration of conformity to declare conformity with the relevant directive on his own responsibility. The declaration of conformity is legally binding.

The declaration of conformity must contain information on the manufacturer, such as name and address, essential characteristics to which the product conforms, all European standards and performance data and the identification number of the notified body, as well as a legally binding signature on behalf of the organisation, if applicable.

Carrying out the conformity assessment yourself as a manufacturer is free of charge, but you must bear the costs if you have it carried out by an external inspection body. The decision to do it yourself or to give the work to a notified inspection body is prescribed for you depending on the product and the applicable EU directives. The costs vary depending on the product to be tested, the certification procedure and the complexity of sourcing your product.

Visibility of the CE symbol is important

The CE symbol must be "visible, legible and indelible".  The marking must include the two letters "C" and "E", which must reflect identical size and proportions, namely at least 5 mm, as long as nothing else is mentioned. In addition, the proportions may not change with a reduction or enlargement of the symbol and must be adhered to. The colour of the symbol may be changed as long as legibility and visibility are not affected.

13. May 2022
|
Certificates

CE certification for machines

CE certification for machines, among other things


"The safety requirements that apply in the field of plant, equipment and mechanical engineering are as diverse as the solutions available there."

CE certification reflects conformity with EU directives regarding product safety as well as product liability. Accordingly, CE certification concerns all manufacturers who distribute a product within Germany or the EU and are affected by the CE directives.  In simple terms, the directives refer to the necessary protection directives related to "ensuring the safety of humans, domestic animals and livestock or in relation to goods".

Products subject to labelling mostly belong to the categories below:

  • Toys
  • Safety articles
  • Medical products
  • Machines

In a large number of product segments, the CE directives are uniform throughout Europe due to the harmonisation process. As a result, it can be said that the CE Directives provide guidance for manufacturers on how products should be manufactured safely and that the documentation is fully set out. In addition, CE certification and the resulting compliance with the directives minimise the liability risks of manufacturers. This is because manufacturers, by signing the declaration of conformity, comply with and vouch for all applicable European directives.

CE as a guideline


The CE symbol is not a seal of quality, but the approval of the given guidelines. This is the sole responsibility of the manufacturer, subsequently the manufacturer does not need permission to use the symbol.

However, the manufacturer must be able to demonstrate the following:

  • The conformity of all necessary EU directives
  • Checking whether you are allowed to test your products yourself or whether you need to involve an external body to check them.
  • Be able to provide the necessary technical documentation showing conformity with the directives.
  • Finally, an "EU Declaration of Conformity" must be written, as well as signed

After ensuring the conformity and marking of the product, you, as the manufacturer, must provide the national authorities with all necessary documents.

Assessment of the machinery (conformity)


Before proceeding with the assessment procedure, it is important to clarify whether you, as the manufacturer, can assess your product yourself or whether you need to involve a Notified Body.

The Machinery Directive 2006/42/EC provides for the intervention of a Notified Body if the product to be assessed falls into one of the 23 categories listed in Annex IV and is not in conformity with a harmonised European standard covering all relevant health and safety requirements.

In this case, the manufacturer shall seek the assistance of a notified body. If this is not the case, the manufacturer himself carries out internal checks on the product.

A notified body verifies the conformity of a product by carrying out a conformity assessment. It also ensures that the technical documentation sufficiently demonstrates the conformity of the product. If the notified body is involved in the production control phase, its identification number will be placed after the CE marking.

If the notified body is satisfied that the product conforms, it issues a certificate of conformity to confirm this. The manufacturer then issues the declaration of conformity to declare conformity with the relevant directive on his own responsibility. The declaration of conformity is legally binding.

The declaration of conformity must contain information on the manufacturer, such as name and address, essential characteristics to which the product conforms, all European standards and performance data and the identification number of the notified body, as well as a legally binding signature on behalf of the organisation, if applicable.

Carrying out the conformity assessment yourself as a manufacturer is free of charge, but you must bear the costs if you have it carried out by an external inspection body. The decision to do it yourself or to give the work to a notified inspection body is prescribed for you depending on the product and the applicable EU directives. The costs vary depending on the product to be tested, the certification procedure and the complexity of sourcing your product.

Visibility of the CE symbol is important

The CE symbol must be "visible, legible and indelible".  The marking must include the two letters "C" and "E", which must reflect identical size and proportions, namely at least 5 mm, as long as nothing else is mentioned. In addition, the proportions may not change with a reduction or enlargement of the symbol and must be adhered to. The colour of the symbol may be changed as long as legibility and visibility are not affected.

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