Conformity Assessment

The Structured Path to CE Marking

CE marking is the mandatory gateway to the European Single Market and is also recognized by many countries outside of Europe. We guide you safely through every stage of the regulatory process to ensure your machinery achieves legally compliant market access, while meeting all requirements of current legislation.

From Design to a Legally Compliant Declaration of Conformity

The Conformity Assessment procedure for machinery is the legally prescribed path to CE marking. Before a product can be placed on the market or put into service, the manufacturer must demonstrate that all relevant health and safety requirements have been met. This process is far more than a formal final inspection. It begins in the design phase and accompanies the product until its completion. European Regulations and Directives define clear milestones for this journey. These include performing the risk assessment, compiling the technical documentation, creating the Instructions for Use, and finally issuing the EU Declaration of Conformity.

Only those who document this process seamlessly are legally protected. We provide this expertise not only for machinery but also support you with procedures for other technical products.

Many companies underestimate the complexity and the time required for this process. Especially during time-critical projects or when internal resources are limited, we take over the full process management for you. We ensure that all formal and technical requirements are fulfilled before the final signature is applied.

We define the correct path for your product and provide measurable relief for your team.

Questions, Answers, and Our Conformity Assessment Services

When Is a Conformity Assessment Required?

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.

What Steps Are Involved in Achieving CE Marking?

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.

What Legal Framework Applies to My Product?

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.

Who Is Authorized to Sign the EU 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.

Does the Procedure Also Apply to Other Technical Products?

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.

Our Working Method at a Glance

Research & Strategy

First, we define the exact legal framework for your project. We identify all directives, regulations, and standards relevant to your specific product and document the results transparently in our proprietary CE Data Sheet. This approach creates a solid foundation for the entire process and ensures that no regulatory requirements are overlooked.

Operational Implementation

We manage the operational workload on your behalf. Our team performs the comprehensive risk assessment, verifies the existing technical documentation, and either creates or optimizes your instructions for use. We handle the entire process efficiently, while ensuring that your internal resources remain focused on your core business.

Completion & conformity

We deliver the finalized documentation to you. You receive the completed EU Declaration of Conformity in a signature-ready format. We ensure that all formal requirements for your signature are strictly met to pave the way for the legally compliant CE marking of your product.

Your Free Initial Consultation

Secure Your Market Access. Whether you are planning to manufacture, import, or build machinery for your own internal use, we manage the entire Conformity Assessment process from start to finish. Our team prepares all required technical documentation and ensures that your product meets every legal requirement of the current Machinery Regulation.


Contact us today for a no-obligation initial consultation to discuss your specific project. We provide the expertise you need to achieve legally compliant CE marking, while avoiding costly delays and minimizing your liability risks.

Further Components of Machinery Safety

The Conformity Assessment process consists of several sub-disciplines that must be closely interlinked to be effective. We provide expert support in all these areas from a single source to ensure a seamless and efficient workflow.

Risk Assessment

The risk assessment forms the technical core of the entire procedure. In this document, we demonstrate that all relevant safety requirements have been met in accordance with EN ISO 12100. It is the mandatory prerequisite for issuing a valid EU Declaration of Conformity.

Instructions for Use

These instructions are a mandatory component of your technical documentation. We create documentation according to current harmonized standards to provide users with clear guidance. We ensure that all residual risks identified in the risk assessment are communicated in a comprehensible and legally compliant manner.

CE Coordination

The conformity process is a complex project involving many internal and external stakeholders. We manage the entire lifecycle for you by coordinating departments and suppliers, while keeping a close watch on all milestones and deadlines until the final signature.