Who becomes the manufacturer of an installation: the operating company, the integrator or the main contractor?
The manufacturer is whoever designs, builds or combines a machine or installation into a functional unit and places it on the market or puts it into service under their own name. This role does not depend on the sign above the door but on what a party actually does: an operating company becomes the manufacturer as soon as it links machines together itself or modifies them substantially.
Which role carries which duties?
| Role | When it applies | Main duties |
|---|---|---|
| Manufacturer | Designs, builds or combines into a unit and places on the market under their own name | Risk assessment, technical documentation, instructions for use, conformity assessment, EU declaration of conformity, CE marking |
| Authorised representative | Appointed in writing by the manufacturer | Keeps the technical documentation available, contact for authorities. Does not take on design responsibility |
| Importer | Brings machinery from third countries onto the EU market | Checks that the manufacturer has carried out the conformity assessment. Carries duties of care of their own |
| Distributor | Passes machinery on without modifying it | Checks marking and accompanying documents. Becomes the manufacturer as soon as they sell under their own name or modify the machine |
| System integrator / main contractor | Combines individual machines into a functional unit | Full manufacturer duties for the whole installation, in addition to the declarations of the individual suppliers |
| Operating company | Operates the installation | Workplace risk assessment, instruction of staff, inspections. Becomes the manufacturer as soon as it links machines or modifies them substantially |
Do I become the manufacturer unintentionally as an operating company?
This is the most common case in practice, and it rarely happens deliberately. Typical triggers:
You buy several machines separately and have the linking done by your own maintenance department or by changing service providers. In doing so you combine the installation into a functional unit.
You extend an existing line by an additional station and integrate it into the existing control system.
You carry out a retrofit in which the control system is replaced or a safety function is changed.
You put an installation from a third country into service for which no valid EU declaration of conformity exists.
In all these cases manufacturer duties arise for the modified or newly created scope: risk assessment, technical documentation, instructions for use, declaration of conformity and CE marking.
How do I clarify the role before the project starts?
What changes with the Machinery Regulation from 2027?
The roles themselves remain essentially the same but are spelled out more clearly. The Machinery Regulation describes the duties of manufacturer, authorised representative, importer and distributor in more detail than the Machinery Directive and names them as economic operators in their own right.
What is new above all is the legal definition of substantial modification in Art. 3(16). It makes the transition from operating company to manufacturer more traceable, and therefore easier to check.
For operating companies this means in practice: the point at which your own interventions trigger manufacturer duties is more clearly defined from 2027 than before. Document changes to your installations accordingly.
Sources and standards
- Machinery Regulation (EU) 2023/1230: duties of economic operators, Art. 3(16)
- Interpretation paper on assemblies of machinery (BMAS, BAuA, DGUV, VDMA, 2011)
- German Ordinance on Industrial Safety and Health (BetrSichV), Section 3: workplace risk assessment
- EN ISO 12100: risk assessment and risk reduction
Editions of standards and their harmonised status change continuously. Check standard numbers and editions against the current list in the Official Journal of the EU before applying them. This article is a technical classification and does not replace legal advice.
Frequently asked questions
What is the difference between operator duties and manufacturer duties?
Manufacturer duties concern the product before it is placed on the market: risk assessment, design, documentation, declaration of conformity, CE marking. Operator duties concern safe operation: workplace risk assessment, instruction of staff, recurring inspections, maintenance.
Do I need a workplace risk assessment despite CE marking?
Yes. CE marking is a manufacturer's declaration about the product. The workplace risk assessment concerns the specific use at the workplace: installation site, ambient conditions, qualification of staff, interaction with other work equipment. Neither replaces the other.
Can I shift the manufacturer role by contract?
Only to a limited extent. You can agree who owes the whole installation and issues the declaration. But whoever actually combines it and puts it into service remains liable towards the outside world. A contract does not protect you from having become the manufacturer in fact.
What if my supplier only provides a declaration of incorporation?
Then it is partly completed machinery. It must not be put into service on its own. Whoever incorporates it has to assess and document the final machinery and issue the declaration of conformity for it.
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This article was produced with AI assistance and reviewed for technical accuracy before publication. Editorial responsibility within the meaning of Art. 50(4) of the AI Act (EU) 2024/1689 lies with Heinrich Knutas.
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