CE marking of machinery and process plants
In Danish
Get an overview of the requirements and ensure that your machine or plant is correctly CE marked, documented, and ready for the market.
CE marking of machinery and process plants is the manufacturer's responsibility. However, the process is rarely simple. It requires a systematic risk assessment, comprehensive technical documentation, a correct instruction manual, and an EC declaration of conformity documenting that the product fulfills the essential health and safety requirements of the new Machinery Regulation (EU) 2023/1230.
For many machinery manufacturers, the challenge is not only understanding the requirements, but translating them into practice: What must the documentation contain? Is the risk assessment sufficient? Who bears the responsibility when multiple partially completed machines are assembled into a single plant?
Danish Technological Institute helps you navigate the requirements and ensure that your machine or process plant is correctly CE marked, safe, and ready for the market.
Do you recognize these challenges?
CE marking of machinery and process plants often highlights issues that are difficult to address without in-depth knowledge of the requirements:
- The risk assessment is incomplete or unsystematic. Many manufacturers struggle to document that all relevant hazards have been identified and addressed in accordance with essential requirements.
- Documentation does not meet the requirements. Technical documentation lacks coherence, or important elements such as calculations, test results, or standard references are incomplete.
- Assembled machinery creates gray areas. When several sub-machines or partly completed machinery are assembled into one plant, it is often unclear who carries the CE marking responsibility for the overall plant.
- Software, CE marking, and cybersecurity. When there is a risk of corruption or tampering, the Cyber Resilience Act (CRA) regulation may be relevant.
- The instruction manual is inadequate. The instruction manual does not meet the requirements of the directive, or it fails to cover the risks identified in the risk assessment.
- Uncertainty about standards. It is unclear which harmonized standards are relevant and whether they have been applied correctly.
- Third-party testing and Type examination. There are new requirements regarding when a machine or safety system must undergo type examination. For example, safety systems with self-learning behavior (AI) must involve a notified body.
- The Machinery Regulation is approaching. The manufacturer knows that requirements are changing, but is uncertain about what this means in practice and when the new requirements apply.
How we help you with CE marking
Danish Technological Institute's specialists advise and assist you throughout the entire CE marking process. We adapt our effort to your situation, whether you need help with the entire process or selected parts:
- Risk assessment. We help you perform a systematic risk assessment in accordance with the Machinery Directive and relevant harmonized standards, ensuring all essential hazards are identified and documented.
- Technical documentation. We review or prepare the technical documentation, including design documentation, calculations, test results, and standard references.
- Instruction manual. We evaluate or draft the instruction manual to ensure it meets requirements and covers the risks identified in the risk assessment.
- Declaration of conformity. We ensure that the declaration of conformity is correctly drafted and refers to the relevant directives and standards.
- Assembled machinery and process plants. We advise on the division of responsibility and CE marking when several machines or partly completed machinery are combined into a single plant.
- Sparring on standards. We help you identify and correctly apply the relevant harmonized 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 specific to your product is a good place to start.
What you get out of collaborating with Danish Technological Institute
CE marking is a legal requirement, but the right advisory services can make the process more than just a formality:
- Lawful market access. You gain assurance that your machine or plant meets essential requirements and can be CE marked and legally sold throughout the EU.
- Stronger documentation. A thorough risk assessment and well-structured technical documentation strengthen not only your CE marking, but also your position in product liability cases, recalls, or authority inspections.
- Reduced risk. A systematic review of safety requirements early in the process can prevent costly changes later in the design or production phase.
- Clarity regarding responsibility. Especially for assembled machinery and process plants, our advice creates clarity on who is responsible for what and how documentation should connect.
- Prepared for the future. By taking the upcoming requirements of the Machinery Regulation into account now, you avoid having to rework documentation from scratch when the regulation enters into force.
- Impartial advisory services. Danish Technological Institute is a self-owning, impartial institution with no commercial interest in how the machine is designed or sold.
Responsibility for CE marking lies with whoever places the machinery on the market in the EU. This is typically the manufacturer, but for assembled machinery or imported products, the distribution of responsibility can be more complex.
When several machines or partly completed machinery are combined into a single process plant, the party assembling and placing the complete plant on the market generally holds the CE marking responsibility for the whole. This requires a comprehensive risk assessment and a declaration of conformity covering the complete plant.
Danish Technological Institute advises on the division of responsibility and helps you ensure that all parties have the necessary documentation in place.
From the Machinery Directive to the Machinery Regulation
The Machinery Directive (2006/42/EC) is being replaced by the Machinery Regulation ((EU) 2023/1230), which is scheduled to apply from January 20, 2027. For manufacturers and plant builders, this transition means, among other things:
- Stricter requirements for risk assessment and documentation
- New requirements for machinery with digital components, software with self-learning functions (AI), and risks of corruption/tampering
- Expanded list of machinery requiring type examination by a notified body (MR Annex I, Part A & B)
- Machinery and assembly of machinery that undergo substantial modification must be fitted with a new CE mark
- Modified requirements for instruction manuals, including the option for digital instruction manuals
Danish Technological Institute monitors developments closely and helps you evaluate what these changes mean for your products and existing documentation.
Contact us
Do you need to CE mark a machine or a process plant, or do you need to strengthen your existing documentation? Contact Danish Technological Institute's specialist, Frits Fynbo, for an initial discussion about your needs.