Under the terms of the Machinery Directive 2006/42/EC, we refer to an assembly of machinery when individual machines interact or are arranged in such a way that they are considered to be a self-contained unit.
To assess whether an assembly of machinery is present, it is necessary to clarify whether any production or safety-related relationship exists.
1. Production relationship?
| Yes | Continue to 2. |
| No | EC declaration of conformity and CE marking for the individual machines |
2. Safety-related relationship?
| Yes | Assembly of machinery under the terms of the Machinery Directive, EC declaration of conformity and CE marking for the assembly of machinery |
| No | EC declaration of conformity and CE marking for the individual machines |
If an “assembly of machinery” exists and an EC declaration of conformity must be issued, the person who builds the “assembly of machinery” from the individual or partly completed machinery, or has it built, is considered to be the manufacturer. This may be the manufacturer of an individual machine or partly completed machinery, or the operator of the resulting “assembly of machinery”. It is important to have this agreed contractually, otherwise the operator will be considered to be the manufacturer.
The person who acts as manufacturer of the “assembly of machinery” is responsible for ensuring that the assembly as a whole meets the health and safety requirements of the Machinery Directive (MD) 2006/42/EC.
The tasks of the manufacturer of the “assembly of machinery” include:
- Compile the technical file: In accordance with Annex VII of the Machinery Directive (MD) 2006/42/EC, the manufacturer compiles the required technical file.
- Risk assessment and risk reduction: The particular focus lies on the interfaces between the connected machines.
- Produce the instructions for use: The manufacturer produces comprehensive instructions for use for the “assembly of machinery” as a whole. The operating and maintenance instructions for the individual machines are also part of the overall documentation.
- Carry out the conformity assessment procedure: In accordance with Article 12 and Annex VIII-X of the Machinery Directive (MD) 2006/42/EC, the manufacturer carries out the relevant procedure for the conformity assessment of the “assembly of machinery”.
- Produce and sign the EC declaration of conformity: In accordance with Annex II of the Machinery Directive (MD) 2006/42/EC, the manufacturer produces the EC declaration of conformity for the “assembly of machinery”.
- Affix the type label and CE mark: The manufacturer affixes a separate type label with the prescribed information and the CE mark to the “assembly of machinery” in accordance with Annex III of the Machinery Directive (MD) 2006/42/EC.
- Integrate the documentation: The EC declarations of conformity and instructions for use for completed machinery, as well as declarations of incorporation and assembly instructions for partly completed machinery that has been incorporated into the “assembly of machinery”, are added to the technical file for the “assembly of machinery”.
It is important to follow these steps carefully in order to guarantee the safety and conformity of the “assembly of machinery”.