Answer: Yes. The legal requirements of the Machinery Regulation (EU) 2023/1230 explicitly mandate a risk assessment for every machine. Every product must comply with the essential health and safety requirements defined by the European Union. The risk assessment is the mandatory prerequisite for demonstrating this compliance and serves as the indispensable foundation for the safety of every machine. It is not a mere formality but a central and legally required document that must be kept as part of your technical file.

Our Service: We support you in creating a standard-compliant risk assessment that meets all current regulatory criteria. We can manage the entire process for you, even during time-critical projects, to provide significant relief to your design department. Alternatively, we offer interactive workshops where we develop the risk assessment together with your team. This collaborative approach not only ensures full legal certainty but also fosters a lasting learning effect and deeper safety expertise within your company.

Answer: The process should begin as early as possible. Ideally, you should start during the initial design phase. At this stage, hazards can often be eliminated most easily through fundamental design changes. In contrast, performing a risk assessment only on a finished machine often leads to expensive retrofits such as additional protective barriers or complex control solutions. It is absolutely essential that the risk assessment is fully completed before the machinery is placed on the market or put into service for the first time.

Our Service: We accompany your design process from the very beginning. By reviewing your CAD designs or concepts at an early stage, we can identify critical safety issues in good time. We help you integrate safety directly into the architecture of your machine according to the Safety by Design principle, thus avoiding unnecessary costs at the end of the project. Even for machines that are already completed, we provide comprehensive support. While we cannot retroactively change the core design, we identify all remaining risks and implement measures to limit your liability as much as possible.

Answer: To prepare a high-quality risk assessment, the limits of the machinery must first be clearly defined. For this, we require detailed information on the intended use as well as reasonably foreseeable misuse. At a technical level, mechanical design drawings are essential. If available at an early stage of the project, pneumatic, hydraulic, and electrical circuit diagrams are also critical for the assessment. Furthermore, functional descriptions and data regarding purchased components help us to evaluate the machine accurately and comprehensively.

Our Service: We make data collection as flexible as possible for your team. Machine data can be recorded either at your premises or, to save time, via online meetings using your digital models. Ideally, we begin our work based on initial design sketches. If the machinery is already complete, we analyze the current status directly on-site.
The time required varies depending on the complexity of the machine and the quality of the preparatory work. While the actual document creation can often be completed within a few days, project-accompanying support during the design phase typically takes several weeks, depending on your progress and the necessary coordination cycles. We would be happy to provide a reliable time estimate based on your available documents and will, of course, sign a Confidentiality Agreement (NDA) in advance.

Answer: The selection of appropriate protective measures follows a legally mandated hierarchy. The so-called Three-Step Method in accordance with Section 6.1 of EN ISO 12100 defines this legal sequence. The first priority is to eliminate risks through inherently safe design. Only if this is not feasible are technical protective measures such as safety fences or light curtains implemented in the second step. The final resort consists of informative measures provided in the instructions for use or directly on the machine. Compliance with the current state of the art is the decisive factor for achieving full legal certainty.

Our Service: We analyze the complex landscape of standards for you and identify the specific requirements relevant to your product. On this basis, we develop customized safety concepts that strike the perfect balance between safety and cost-effectiveness. Even the legislator requires that technical and economic requirements are taken into account during the safety integration process. We consistently implement this requirement on your behalf. Our objective is to achieve the optimum balance between maximum legal certainty, minimized liability, and economic rationality. We help you avoid unnecessarily expensive technical solutions by prioritizing intelligent design approaches.

Answer: Section 7 of EN ISO 12100 specifies that the risk assessment must document the results achieved. However, neither the standard nor the legislator mandates a specific visual design or layout. For verification purposes and to serve as valid proof of your duty of care, the documentation must be maintained in either digital or physical written form. This documentation is essential to protect your company in the event of a liability claim.
Important note on disclosure: As a manufacturer, you are under no legal obligation to provide the risk assessment to your customers under the Machinery Regulation (EU) 2023/1230. It remains a strictly internal component of your technical documentation. Conversely, if you are a purchaser and wish to receive a supplier's risk assessment, this must be explicitly defined in the purchase contract. Without such a clause, there is no legal entitlement to these internal documents.

Our Service: We adapt seamlessly to your existing infrastructure to ensure that you can continue to work effectively with the results. We are proficient in all common formats, whether you utilize standard software like Word and Excel or specialized safety solutions such as Safexpert. If your company does not yet have an internal template, we can develop a customized, standard-compliant template for you. In every case, you receive a legally secure document for your internal records. This approach ensures that your proprietary technical know-how remains protected within your company while you fulfill all legal documentation requirements.