Specific to the Machinery Directive
Essentially, the Machinery Directive says that every piece of machinery which falls within its scope must be CE marked to show that it is safe. However, some machines are supplied as components or sub-assemblies for other, bigger machines and cannot be considered as safe when delivered by the manufacturer, so the manufacturer can't legitimately CE mark them. The Declaration of Incorporation plugs this gap.
The Declaration of Incorporation is a document which accompanies incomplete machinery and states;
- this piece of machinery is incomplete and only complies with some parts of the directive.
- It therefore cannot be CE marked by us.
- the manufacturer of the complete machine must ensure it complies with the whole Machinery Directive.
- The Manufacturer must then complete a Declaration of Conformity
The Directive also requires the manufacturer to identify which aspects of the equipment they are taking responsibility for, by declaring the Essential Requirements which have been fulfilled by them. Compliance with the other Essential Requirements will be the responsibility of the person who assembles (and CE marks) the complete machine.
Additionally, the manufacturer of partly completed machinery must make a statement undertaking to deliver their technical file directly to the authorities when requested. This is to ensure that the authorities can obtain a complete file for the final machinery without the manufacturer of the partly completed equipment having to provide the proprietary details of their products to their customers.
The concept of the Declaration of Incorporation only exists within the Machinery Directive, which is a shame since it's actually quite a useful concept which could be extended to other CE marking directives, in particular the Low Voltage Directive.
The basic rule when choosing between the Declaration of Conformity and the Declaration of Incorporation is whether or not the assembly is CE marked under the Machinery Directive. If it is marked, a Declaration of Conformity must be completed. If it is not marked under the Machinery Directive (even if it carries a CE logo to show conformity with other Directives) it must be accompanied by a Declaration of Incorporation.
The choice between whether to issue a Declaration of Conformity or a Declaration of Incorporation is sometimes finely balanced, but the key deciding factors are as follows:
- As supplied, the equipment must be incapable of operating.
- The supplier must expect the installer to carry out a further conformity assessment procedure before the complete machinery is brought into service. If the manufacturer supplies machinery without some components but gives full instructions how to complete the machinery and make it compliant then it is “machinery without a drive system” and must be CE marked.
- Declarations must be either typewritten or hand-written in block capitals
- Declarations must be written in the same language as the instructions supplied with the machine.
- A unique Declaration should be supplied with each machine in a series production situation.
It is common to combine the declarations for all applicable directives into one document.
With this in mind, we have prepared a series of documents which will help you to draft declarations for the most common Directive.These editable drafts (in Word.docx format) are available for a small charge from our online shop - see the links below for the relevant draft declaration.
the Machinery Directive
the Declaration of Conformity