CE Compliant Machines for Predictable Results
As experts in machine safety, we support you in demonstrably meeting all legal requirements for CE marking. We advise you on the necessary safety measures and help you choose cost-effective and compliant solutions.
Consulting and detailed assessment
at your facility
Professional execution
of the CE conformity assessment procedure
Innovative and clearly structured documentation
Legal compliance of your machines
through CE-compliant documents
Machines according to the Machinery Directive 2006/42/EC and the Machinery Regulation 2023/1230
Every manufacturer of a machine or system is required to place their product on the market in a safe and CE-compliant manner. They are responsible for accidents or health hazards caused by the machine or its use.
Therefore, it is essential that the manufacturer ensures that their product is not only technically safe, but also executed in accordance with the directives and, therefore, legally compliant.
The manufacturer is anyone who:
- Places a complete or incomplete machine on the market within the EU economic area.
- Modifies an existing machine or system in such a way that new hazards have arisen or the original risks have been significantly increased.
- Combines multiple machines into a whole.
- Anyone who makes a machine available for the first time in the European Economic Area through import or commissioning assumes the responsibility of the manufacturer and must ensure CE-Conformity.
You build the machine...
we provide the documentation
CE-Conformity of Your Machines
The CE conformity of a machine is the formal declaration by the manufacturer that the product complies with all applicable legal requirements.
This includes not only meeting safety and health requirements, but also the creation of comprehensive technical documentation that clearly demonstrates the machine's conformity.
The documentation includes:
- Risk Assessment
- Evaluation of the functional safety of safety devices
- Operating Manual
- Directive-compliant Declaration of Conformity
Steps to Conformity
We guide you through simple steps to achieve CE conformity for your machine
1
Step 1
Contact
After an initial assessment of your individual situation and machine configuration, we will provide you with an offer for the conformity evaluation.
2
Step 2
On-site Assessment at Your Facility
We review existing documentation, analyze potential hazards, and discuss concrete measures for risk reduction.
Our standardized questionnaires and checklists serve as the basis for standards research and later document creation.
Typically, the assessment takes a full working day.
3
Step 3
Draft Documentation
Approximately 2 to 4 weeks after the assessment, we will send you the drafts of the risk assessment and the operating manual.
You review the documents, add missing information, and send us your corrections along with any necessary images or other documents.
4
Step 4
CE-Compliant Machine
You will receive the complete documentation from us. Your machine now meets all applicable CE requirements and is legally compliant. You can fully focus on your core business.
Risk Assessment
The risk assessment is legally required – and your key to greater safety. It identifies hazards on the machine, evaluates risks, and defines appropriate protective measures.
We create a well-structured and compliant risk assessment for you and work with you to define measures for effective risk reduction.
For more information, see FAQs.
Operating Manual
Safe machines need clear instructions!
An unclear operating manual can lead to operator errors, accidents, and legal consequences. We create a professional and compliant operating manual for you – clearly written and tailored to your target audience.
Your Benefits:
Legal certainty & CE compliance
Clear structure & easy readability
Customized for the machine and user
Functional Safety for Machines
What is functional safety? The safety of a machine is ensured through a combination of various measures – including design and technical protective measures, user information, and safety-related controls.
These safety controls include, among others, emergency stop systems, light curtains, two-hand controls, safety mats, or door locks.
These systems typically consist of three functional components: sensor (detection), control logic (evaluation), and actuator (execution).
Plan Safely – Implement According to Standards!
We support you in implementing functional safety according to EN ISO 13849 – protecting people, machines, and production sustainably.
Safety Concepts for Machines
Control Validation
CE-Documentation
About Us
We are dedicated and innovative professionals specializing in machine safety. With many years of experience in mechanical engineering, automation, and process engineering, we bring in‒depth technical expertise and practical solutions to every project.
Our goal is to support companies in meeting the highest safety standards while simultaneously improving the efficiency of their production processes.
Our focus is on conducting CE conformity assessments, creating comprehensive risk assessments, and providing legally compliant operating manuals, all tailored to the specific needs of our clients.
We understand the complex challenges surrounding safety and health protection requirements – and deliver actionable, cost‒effective, and compliant solutions that ensure both legal certainty and machine safety.
Thomas Lorenz
CE-Coordinator (Tüv)
CMSE Certified Machine Safety Expert (Tüv)
Juan Garcia
Occupational Safety Specialist
Speaker at BG RCI
Radiation Protection Officer
Expert in Hazardous Substances and Storage
Customer Testimonials
Reliable Experts
We have already successfully completed several projects with the support of CE Expert.
Especially when it comes to the conformity assessment of technically demanding machines, reliability and clear communication are crucial – and this is exactly what stands out in our collaboration with CE Expert.
The risk assessments and operating manuals are clearly structured, clearly written, and both manufacturer- and operator-friendly.
We are very satisfied with the collaboration with Mr. Lorenz and CE Expert and look forward to further joint projects.
Uwe Winter
Managing Director of Widoberg GmbH
Frequently Asked Questions
Everything You Need to Know About CE-Conformity
When is a machine CE-compliant?
1. Safety according to the state of the art: The machine must be safe for humans and the environment, which implies that it must comply with the current state of the art (Annex I of the Directive).
2. Complete technical documentation: Technical documentation (including risk assessment, drawings, circuit diagrams, etc.) according to Annex VII must be provided.
3. Compliance with all other requirements of the Directive: This includes, among other things, the declaration of conformity, affixing the CE mark, and, if applicable, an EC type examination if required.
What are the steps to CE-Conformity?
1. Compilation of existing relevant documentation
2. Research on directives and standards
3. Determination of the conformity assessment procedure
4. Creation of the risk assessment
5. Evaluation of the functional safety of safety controls
6. Implementation of risk-reducing measures
7. Creation of the operating manual
8. Issuance of the declaration of conformity
9. Affixing the CE mark
Most of these steps involve several sub-steps that need to be considered.
How long does the complete CE conformity assessment procedure take at CE Expert?
Quality, efficiency, and fast implementation are our focus. Typically, you will receive the first draft of the documents within 2-3 weeks. The total project duration is usually 4-6 weeks, but it can take significantly longer. This depends on the complexity of the machine or system and what documents are already available.
How much does the conformity assessment procedure cost?
The cost of a conformity assessment procedure is difficult to estimate generally, as machines vary greatly depending on technology, design, size, and the documentation effort required.
For straightforward machines of medium complexity, the costs for the complete procedure typically range from 4,000 to 7,000 euros.
If a company carries out the CE marking process independently in-house, a similar cost range can be expected. This includes expenses for:
- Acquiring specialized software
- Internal time efforts for planning, coordination, and execution by qualified personnel.
What are the steps of a risk assessment?
1. description of the machine and all limits
2. identification of possible hazards
3. assessment of the risks of the respective hazards
4. risk assessment
5. definition of risk-reducing measures
6. renewed risk assessment and evaluation after measures have been taken
What is an incomplete machine?
Partly completed machinery is a product that already has the characteristics of machinery but cannot fulfill a specific function on its own.
It is intended to be combined with one or more complete or partly completed machines to form a functional complete unit.
Important:
Components such as ball bearings, couplings or gearboxes are not considered partly completed machinery, as they are not typical machine elements with independent mechanical movements or control functions.
Partly completed machinery is
- no CE marking
- no declaration of conformity, but a declaration of incorporation
- no operating instructions, but assembly instructions
- a marking that enables clear assignment to the manufacturer, declaration of incorporation and assembly instructions
- a risk assessment in accordance with the Machinery Directive
When is a machine “substantially” modified?
Whether a machine is subject to a significant modification depends on the type of modification. The actual extent of the modification only plays a subordinate role.
If the modification has created a new hazard or increased an existing risk and existing or very simple new protective measures are not sufficient, the machinery is substantially modified.
Does machine safety and CE marking affect me as a machine dealer?
Yes, as a machine dealer, machine safety affects you directly. Because:
As soon as you advertise, offer for inspection or sell a machine, you are placing it on the market - even if it is a used machine. If this takes place in the European Economic Area, the Product Safety Regulation (EU) 2023/988 applies, which stipulates that only safe products may be placed on the market.
As a rule, a CE-compliant machine with CE marking is considered safe within the meaning of the regulation.
Special feature for older machines:
Machines built before 1995 do not have a CE marking. In such cases, the responsibility lies with the dealer:
He must ensure that the machine can be operated safely according to the current state of the art.
Ideally, the dealer should draw up a risk assessment and document that sufficient risk-reducing measures have been taken.
I am an operator and would like to automate a machine - do I need a new CE marking?
In most cases, the answer is yes.
If an existing machine is automated, this can lead to new hazards or an increase in existing risks. If the original protective measures are no longer sufficient, the original CE conformity expires.
In this case, the machine is considered to be substantially modified - the operator legally becomes the manufacturer. This means that a new conformity assessment procedure must be carried out, which is concluded with a new CE marking.
Conclusion:
As soon as automation results in safety-relevant changes, the machine must be reassessed - including risk assessment, technical documentation and CE marking.
Why are risk assessment and operating instructions important for a machine?
The risk assessment and operating instructions for a machine are of central importance for several reasons, especially with regard to the Machinery Directive 2006/42/EC or Machinery Regulation 2023/1230 and CE conformity:
1. safety standards: a risk assessment ensures that potential hazards posed by the machine are identified, evaluated and documented. This makes it possible to take appropriate risk-reducing measures to minimize the remaining risk. Without a proper risk assessment, unsafe operating conditions may persist, which can lead to accidents or serious injuries.
2. legal requirements: The Machinery Directive and Machinery Ordinance require the risk assessment and operating instructions to be prepared and retained to ensure that machinery complies with the necessary safety requirements. Proof that these documents are available and have been drawn up correctly is necessary for CE marking and can be decisive in the event of an accident or inspection by the authorities.
