Answer: A group of machines is considered a single unit if a technical connection exists between several machines in terms of production and safety. The decisive factor is that the interconnection creates a closed unit with close interactions. For this reason, the hazards of the group as a whole are not covered by the conformity of the individual machines. As a result, it is essential to issue a new Declaration of Conformity to confirm that the assembly as a whole is safe in accordance with the current state of the art.

Our Service: Before we provide support in the complex conformity assessment procedure for an assembly of machinery, we carefully check whether it actually constitutes an assembly in the legal sense. We support you in the early stages of the project and evaluate options for avoiding an assembly of machinery in a legally compliant manner. This allows you to rule out future costs and liability risks for machinery from other manufacturers. We are also happy to mediate between you and your clients to clarify the question of an assembly of machinery in a neutral manner.

Answer: The manufacturer of the assembly is the party responsible for linking several individual units of machinery. This is often a general contractor, an integrator, or the operator itself, provided that it carries out the interconnection independently. This new manufacturer assumes full responsibility for the safety of the entire system. It must ensure that the interaction of the individual machinery does not give rise to any unacceptable risks and that interfaces are controlled in terms of safety. In addition, the manufacturer is responsible for carrying out the conformity assessment procedure.

Our Service: We support you in fulfilling your complex manufacturer responsibilities in a legally compliant manner. We take over the operational implementation of the conformity assessment procedure for your entire system. We prepare the necessary risk assessment and evaluate the interactions between the individual machinery. You will receive documentation ready for decisions on the basis of which you can sign the declaration of conformity for the entire system with confidence. Furthermore, we are happy to review the contract and mediate between all parties involved to clearly identify the responsible entities. If you do not wish to act as the manufacturer of an assembly of machinery, it is necessary to address the legal framework at an early stage.

Answer: Please do not remove the markings and type plates from the individual machinery when you link them together to form a complete system. The original CE markings and declarations of conformity for the individual machinery remain valid but are no longer sufficient in the context of the assembly. The documentation for the individual machinery becomes a mandatory part of the new technical documentation for the entire system. The CE marking for the entire system thus encompasses the individual machinery and their interfaces. This creates something greater than the sum of the individual parts.

Our Service: First, we review and consolidate the documentation for the individual machinery. In doing so, we identify gaps in the interface considerations of the original manufacturers and carry out the necessary new analyses. We then integrate all certificates and evidence into new uniform technical documentation for the entire system that meets all legal requirements. We are also happy to support you in purchasing to ensure all relevant documents are requested when procuring individual machinery, which facilitates the creation of the overall documentation.

Answer: When creating an assembly of machinery, a new conformity assessment procedure is required. This procedure includes a new risk assessment that specifically applies to the assembly. In addition, proof of the functional safety of the common control system and the respective performance level must be provided. Master instructions for use, a new type plate, and a new EU declaration of conformity for the entire system are also mandatory. In principle, the procedure is the same as for a single unit of machinery. The difference lies in the complexity as risks associated with purchased parts or machinery from other manufacturers are often unknown. Without a solid documentation basis, the effort required to assess conformity often increases exponentially.

Our Service: We create all the necessary documents from a single source, including the overarching risk assessment, the validation of common safety functions, the new declaration of conformity, and the overarching instructions for use. We ensure that the documents are consistent and free of contradictions. You do not have to deal with the various standards and documentation for the individual machinery. Ideally, you should involve us at an early stage of the project. This allows us to define the scope of delivery for purchased machinery in advance with precision so that a seamless and cost-effective integration into the overall system is achieved.

Answer: Yes, classification can be avoided if the criteria of an assembly of machinery are not fully met. The decisive factor is often the so-called safety-related connection. If it is possible to separate the individual machinery from each other in terms of safety, there is no assembly within the meaning of the Machinery Regulation (EU) 2023/1230. In practice, we often achieve this by decoupling the individual machinery from each other in terms of safety and using them as independent safe units. As long as an event on one unit does not lead to a hazard on the adjacent machinery, no new CE marking is required for the entire system.

Our Service: We advise you right from the layout phase of your system. We analyze the planned interlinking and develop concepts for the safety-related decoupling of the individual machinery. We show you ways in which you can legally avoid the manufacturer obligations for an assembly by using intelligent interface design. If decoupling is not technically feasible, we efficiently guide you through the necessary conformity procedure.