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Answer: The legislator stipulates that this procedure is mandatory for specific products before they are placed on the market or put into service for the first time within the European Economic Area (EEA). Traditionally, this obligation lies with the manufacturer. However, importers who distribute products under their own brand or companies that build machinery purely for their own internal use are also deemed manufacturers under the law. Without proof of a successfully completed procedure, market access is illegal and poses significant liability risks.
Our Service: We begin by analyzing your exact role as an economic operator. We clarify whether you are acting as a manufacturer, authorized representative, importer, or distributor and identify the specific obligations associated with that role. We guide you safely through the requirements to prevent you from unknowingly assuming liabilities that do not apply to you. Furthermore, we determine if a formal assessment is required for your product at all to help you avoid unnecessary costs.
Answer: The path to CE marking follows a logical and legally defined sequence. First, we identify the specific European regulations, directives, and harmonized standards applicable to your product. From this legal and normative framework, we derive the exact requirements your machinery must fulfill. A fundamental step is the risk assessment, which documents all potential hazards and the corresponding mitigation measures. Simultaneously, the technical documentation must be compiled and the instructions for use must be prepared. Only after all relevant requirements are successfully met may the manufacturer issue the EU Declaration of Conformity and affix the CE mark to the product.
Our Service: We provide structured support through every single stage of the process. Our team determines the applicable legal framework, researches the latest standards for your product, and performs the necessary risk assessment. We verify your technical documentation for completeness and ensure that your instructions for use are fully compliant with current laws. Finally, you receive an EU Declaration of Conformity ready for signature. We ensure that no step is overlooked and that your product reaches the market in full compliance with the law.
Answer: Many manufacturers focus solely on the Machinery Regulation (EU) 2023/1230 when assessing their products. However, this approach is often insufficient because a single product is frequently subject to several EU regulations simultaneously. In addition to machinery-specific requirements, other laws such as the EMC Directive, the Radio Equipment Directive, or the RoHS Directive often apply. For a valid CE marking, all relevant directives and regulations must be identified and applied without exception. Failure to comply with even one applicable regulation invalidates the entire Declaration of Conformity.
It is also vital to understand the difference between the two legal levels: Regulations and directives define the law regarding what must be fulfilled, while harmonized standards provide the technical solution on how to fulfill it. Only the correct application of both levels creates true legal certainty.
Our Service: We analyze your product holistically and identify all relevant European directives and regulations. We document these findings in our specially developed "CE Data Sheet". This document consolidates the complete legal and normative framework, the manufacturer specifications, and the precise definition of the intended use. As a result, the CE Data Sheet forms the binding foundation for the subsequent risk assessment and the final Declaration of Conformity.
Answer: To be legally binding, the declaration must be signed by the manufacturer, represented by the management or a specifically authorized person within the company. By signing this document, the manufacturer assumes full responsibility for the product's conformity. As your consultant, we cannot take this step for you because the signature is inextricably linked to the legal role of the manufacturer. A fundamental prerequisite for a legally valid signature is a precise and documented knowledge of the entire legal framework.
Our Service: We prepare the EU Declaration of Conformity for you in a signature-ready format. The content is based on the previously developed CE Data Sheet, which transparently lists and correctly assigns all applicable directives, regulations, and harmonized standards. You receive a document that accurately reflects the legal framework of your specific product. We provide you with the confidence of knowing exactly what you are signing, while minimizing your personal liability risk through technical and legal precision.
Answer: Yes. The requirement for CE marking is not limited to machinery. A wide range of technical products, including lighting systems, control cabinets, and pressure equipment is subject to Union harmonization legislation. This includes regulations and directives such as the Low Voltage Directive (LVD), the EMC Directive, or the Pressure Equipment Directive (PED). For these products, a specific conformity assessment must be completed, technical documentation must be prepared, and a formal Declaration of Conformity must be issued before market placement.
Our Service: Our expertise extends far beyond mechanical engineering. We support you with the CE marking process for products that fall outside the scope of the Machinery Regulation (EU) 2023/1230. We identify all applicable directives such as the LVD, EMC, or the Radio Equipment Directive (RED) and prepare the necessary evidence for compliance. Whether you are developing purely electrical devices or complex process engineering systems, we ensure that your product is fully marketable within the European Single Market.