When is CE conformity the user's responsibility?
Machine safety
When building, substantially modifying or assembling a production line, the user/integrator can legally become the manufacturer. We explain in which scenarios this happens and how to secure final responsibility contractually and technically.
More often than you might think, as a user/integrator you are yourself the manufacturer within the meaning of CE legislation. This is the case when you build a machine, substantially modify it or combine machines into an assembly of machinery (production line). The manufacturer's obligations then rest with you: risk assessment, compiling the technical file, the (EU) declaration of conformity and CE marking.
Situations examined more closely:
1) You build a machine yourself for your own use
You are the manufacturer and follow the full CE route: risk assessment, selecting the applicable standards, compiling the technical file, drawing up the (EU) declaration of conformity and affixing the CE marking. This obligation does not lapse because you do not sell the machine; putting a machine into service is enough to fall under the obligation.
2) You modify a machine
The impact of the modification determines the approach:
- Minor modification (within the intended use, no impact on safety functions/risks): document it; the existing CE can be retained.
- Substantial modification (performance/use changes, new hazards, changes to safety functions/architecture): treat it as a new or substantially modified machine → you become (co-)manufacturer of the modified part or the whole. Start with a risk assessment; it determines the further conformity steps.
3) You have an existing machine modified or extended
- By the original manufacturer/integrator: stipulate contractually that they deliver the entire line CE-compliant (updated declaration and file).
- By another supplier: keep an eye on the overlap between scopes of supply. If nobody takes on the integration CE, the responsibility falls to you. Explicitly define who is the manufacturer with final responsibility.
Read more on this: Do you become a manufacturer when you modify a machine?
4) You build an installation with several suppliers
The line is an assembly of machinery. Someone must demonstrate that the whole complies as a single system (interfaces, emergency stop chain, reset logic, functional safety, instructions). Explicitly appoint a line integrator who acts as manufacturer of the assembly and issues an (EU) declaration of conformity for the assembly, or act as manufacturer of the assembly yourself.
