Consultancy on CE marking of machinery - Requirements, process, and documentation
In Danish
Get an overview of the requirements in the Machinery Directive and Machinery Regulation to ensure that your machine is correctly documented, risk assessed, and ready for CE marking.
CE marking of machinery is the manufacturer's responsibility, but the process is rarely straightforward. It requires that you identify the relevant directives and standards, perform a systematic risk assessment, prepare technical documentation, and draft a correct declaration of conformity. Every step depends on the previous ones being executed correctly.
Many manufacturers find it difficult to translate requirements into practice, particularly when the machinery is complex, when multiple directives are involved, or when it is the company's first time going through the process.
Danish Technological Institute advises manufacturers on CE marking in accordance with the new Machinery Regulation (EU) 2023/1230, which manufacturers should begin preparing for now. We help you understand the requirements, structure the process, and ensure that your documentation is in order.
From legal requirements to practice: where the challenges arise
CE marking often raises questions that require specialist knowledge to answer. Here are the challenges we encounter most frequently:
- Uncertainty about which directives apply. Many machines are covered by several EU directives simultaneously, e.g., the Machinery Directive, the Low Voltage Directive, and the EMC Directive. It is not always clear which requirements apply and how they interact.
- The risk assessment is unsystematic or incomplete. The manufacturer has assessed some risks, but the process is insufficiently documented, or relevant hazards have been overlooked.
- Uncertainty regarding harmonized standards. Navigating which standards are relevant for a specific machine and whether they have been applied correctly can be difficult.
- Incoherent technical documentation. Design drawings, calculations, test results, and instruction manuals are prepared independently of one another and lack cohesion.
- The instruction manual does not meet requirements. The instruction manual is inadequate, outdated, or fails to cover the risks identified in the risk assessment.
- The declaration of conformity is incorrect. The declaration refers to incorrect directives or standards, or it is not formatted properly.
- The Machinery Regulation creates uncertainty. The manufacturer knows new requirements are coming, but is uncertain about what this means for existing products and processes.
Consultancy tailored to your situation
Danish Technological Institute's specialists advise you through the necessary steps to correctly CE mark your machine. We adapt our efforts to your situation, whether you need help with the entire process or a single step:
- Identification of relevant directives and requirements. We map out which EU directives apply to your machine and help you understand what each directive requires.
- Scoping requirements related to software, CE marking, and cybersecurity. When there is a risk of corruption or tampering, the Cyber Resilience Act (CRA) regulation may be relevant.
- Evaluation of the need and requirements for third-party testing by a notified body.
- Risk assessment. We help you execute a systematic risk assessment in accordance with DS/EN ISO 12100 and relevant C-type standards, ensuring all essential hazards are identified, evaluated, and documented.
- Selection and application of harmonized standards. We help you identify relevant standards and evaluate whether they are applied correctly in your design.
- Review or preparation of technical documentation. We ensure that design documentation, calculations, test results, and standard references are cohesive and meet requirements.
- Instruction manual. We review or help prepare the instruction manual so that it meets requirements and covers the risks identified in the risk assessment.
- Declaration of conformity. We ensure that the declaration is correctly drafted and refers to the relevant directives and standards.
- Preparation for the Machinery Regulation. We advise on what the transition from the Machinery Directive to the Machinery Regulation means for your products and documentation. A GAP analysis specifically for your product is a good place to start.
More than a declaration of conformity
CE marking is a legal requirement, but the right advisory services create value beyond the mark itself:
- Clarity in a complex process. You gain an overview of the requirements and a structured plan for what needs to be done and in what order. This saves time and reduces uncertainty.
- Stronger documentation. Thorough and cohesive technical documentation strengthens not only your CE marking, but also your position in product liability cases, customer complaints, or authority inspections.
- Fewer errors and costly corrections. When the risk assessment and application of standards are correct from the start, it reduces the risk of design changes or recalls later.
- Safety for employees and users. A systematic CE marking process ensures that the machine meets safety requirements in practice, not just on paper.
- Prepared for new requirements. By taking the upcoming requirements of the Machinery Regulation into account now, you avoid having to start from scratch when the regulation enters into force.
- Impartial advice. Danish Technological Institute is a self-owning, impartial institution. We advise based on requirements, not commercial interests.
The CE marking process step by step
CE marking of machinery follows a systematic process based on the requirements of the Machinery Directive (2006/42/EC):
- Identify relevant legislation. Determine which EU directives and regulations apply to the machine, and which essential requirements apply.
- Find relevant harmonized standards. Identify the standards that support the essential requirements and evaluate whether they can be applied to your machine.
- Perform a risk assessment. Identify hazards, assess risks, and determine the necessary risk-reduction measures.
- Prepare technical documentation. Compile design documentation, calculations, test results, risk assessment, and the instruction manual into a technical dossier.
- Draft the declaration of conformity. Declare that the machine fulfills the relevant directives and standards.
- Affix the CE mark. Affix the CE mark visibly to the machine.
Danish Technological Institute can assist you with all steps or selected parts, depending on your needs and resources.
Contact us
Do you need to CE mark a machine, or are you unsure whether your current documentation holds up? Contact Danish Technological Institute's specialist, Frits Fynbo, for an initial discussion about your situation.
FAQ