Seven Steps to a CE Mark: 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 with the new Machinery Directive coming into force, some new 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.

Potential assessment procedures in accordance with the new Machinery Directive.