The Seven Steps of CE Marking Explained: Step 2- Check the Application of Additional Directives

Step 2: Check the application of additional directives

Where machinery is also subject to other EU directives, which cover different aspects but also provide for the affixing of the CE mark, the provisions of these directives must be met before the CE mark is applied. If the machine contains electrical equipment, for example, it will often be subject to the Low Voltage Directive and, possibly, the EMC Directive too.

The Seven Steps of CE Marking Explained: Step 1- Categorize the Product

Step 1: Categorize the product
The CE marking process starts by categorizing the product.
The following questions need to be answered:

• Is the product subject to the Machinery Directive?

Here it's important to note that, when the new Machinery Directive comes into force, some products have been introduced (e.g. pressure vessels, steam boilers and funicular railways), while others have been omitted (e.g. electrical household and office equipment).

• Is the product listed in Annex IV of the Machinery Directive?

Annex IV of the Machinery Directive lists machinery that is considered “particularly hazardous”, such as presses, woodworking machinery, service lifts, etc. In this case, CE marking and the declaration of conformity must meet special requirements.

• Is the machine a subsystem or partly completed machinery?

Manufacturers issue an EC declaration of conformity for functional machines that meet the full scope of Annex I of the Machinery Directive. For subsystems, e.g. robots, which cannot yet meet the full scope of Annex I, the manufacturer issues a manufacturer's declaration in accordance with Annex II B.
The new Machinery Directive refers to subsystems as “partly completed machinery”. From the moment the new Machinery Directive becomes valid, all partly completed machinery must be accompanied by a declaration of incorporation in accordance with Annex II. At the same time the manufacturer must perform a risk assessment and provide assembly instructions in accordance with Annex VI. Effectively the manufacturer's declaration or declaration of incorporation bans the subsystem from being put into service, as the machine is incomplete and as such may not be used on its own.

• Is it a safety component?

Under the old Machinery Directive, safety components are treated separately and are not awarded a CE mark, although it is necessary to produce a declaration of conformity. Under the new Directive they will be treated as machinery and will therefore be given a CE mark.

Seven Steps to a CE Mark

Check out these seven steps to CE marking

Decision trees and analysis for safety hazards

Essentially the Machinery Directive describes the requirements for new machinery. However, if a machine is modified to such an extent that new hazards are anticipated, an analysis will need to be carried out to determine whether the upgrade constitutes a significant modification. If this is the case, the measures to be taken will be the same as those for new machinery. The analysis usually follows a decision tree format, as seen above.

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New machine or old machine? Does it need to be CE Marked?

When a machine is imported from a third country for use within the EU, that machine must comply with the Machinery Directive when it is placed on the market and when put into service. Anyone who places a machine on the market for the first time within the European Economic Area must have the necessary documentation to establish conformity, or have access to such documentation. This applies whether you are dealing with an “old machine” or new machinery.

My machines are CE marked, do I still need to certify my plant?

On large production lines a machine may often consist of several individual machines assembled together. Even if each of these bears its own CE mark, the overall plant must still undergo a CE certification process.

Do you need to CE certify?

Irrespective of the place and date of manufacture, all machinery used in the European Economic Area for the first time beginning January 1, 1995 is subject to the EU Machinery Directive and as such must be CE certified.

Safety Planning Tip

It’s important that the manufacturer considers the safety aspect early, as the contracts are being formulated or in the components’ requirement manual. The documentation shall not be compiled solely from the point of view of machine performance. The manufacturer is responsible for the whole of the technical documentation and must determine the part that each of his suppliers are to undertake in this process.