CE-Conformity assessment | CE Expert | Risk assessment for mechanical engineering companies. Europe, Asia and USA

CE Compliant Machines for Predictable Results

As specialists in machine safety, we support you in achieving full compliance with all legal requirements for CE marking. We work side-by-side with you to create smart, cost-effective solutions that are clear, compliant, and proven to deliver results.

On-site consulting and detailed assessment of your machine

Professional execution

of the CE conformity assessment procedure

Innovative, clearly structured documentation for easy understanding

Verified legal compliance through CE-compliant technical files

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for CE Conformity

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

Risk Assessment

Operating Manual

Functional Safety

Declaration of Conformity

Legally Compliant Documents

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for CE-Conformity

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.

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for CE-Conformity

Risk Assessment

A risk assessment is not only a legal obligation - it is a powerful tool for improving safety. It enables you to identify hazards on your machine, evaluate potential risks, and define effective protective measures. A clear, well-structured risk assessment supports informed decision making, contributes to long-term risk reduction, and forms an essential part of the CE-technical documentation required under the Machinery Directive 2006/42/EG. For more details, see our FAQs.

Operating Manual

Clear instructions are essential for CE-compliance and the safe use of your machine.

A precise, well structured manual prevents errors, ensures proper handling and operating, and demonstrates that your machine meets legal requirements.

Your Benefits:

CE compliant & legally secure

Easy to read, clear structure

Customized for your machine and its users

Functional Safety for Machines

What is functional safety? It ensures that a machine operates safely even when faults ocur. It is achieved by combining design features, technical protective measures, user information, and safety related controls. Common safety controls include emergency stop systems, light curtains, two-hand controls, safety mats, and door interlocks.

Plan Safely and Implement According to Standards!

We help you implement functional safety in line with EN ISO 13849, protecting people, machines, and production sustainably.

Safety Concepts for Machines

Control Validation

CE-Compliant Documentation

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for CE-Conformity

We are dedicated and innovative professionals specializing in machine safety. With extensive experience in mechanical engineering, automation, and process engineering, we deliver technical expertise and practical solutions for every project.

Our mission is to help companies meet the highest safety standards while improving production efficiency. We focus on:

CE conformity assessments
Comprehensive risk assessments
Legally compliant operating manuals, customized for each client

We understand the complexities of safety and health requirements and provide actionable, cost-effective solutions that ensure both legal certainty and machine safety.

About Us

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

Through continuous training and close collaboration with industry experts, we stay up to date with the latest technologies and legal requirements. Rely on our experience and commitment to ensure your machines are both safe and efficient.

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 Machinery Directive: The machine must be safe for humans and the environment, which implies that it must comply with the Essential Health and Safety Requirements (Annex I of the Directive).

2. Complete technical documentation: Technical documentation (including risk assessment, drawings, circuit diagrams, etc.) according to Annex VII, Machinery Directive, 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?

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 5,000 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?

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 has

- 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?

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 old 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 one of my machines. 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?

Risk assessment and operating instructions are essential for machine safety, legal compliance, and CE conformity, particularly under the Machinery Directive 2006/42/EC and Machinery Regulation 2023/1230.

1. Safety Standards A risk assessment ensures that potential hazards posed by the machine are identified, evaluated, and documented. This allows for the implementation of appropriate risk-reducing measures, minimizing residual risk. Without a proper risk assessment and a clear operating manual, unsafe operating conditions may persist, potentially leading to accidents or serious injuries.

2. Legal Requirements Both the Machinery Directive and Machinery Regulation require that risk assessments and operating instructions are prepared, retained, and available. Proper documentation is necessary for CE marking and can be decisive in the event of an accident or regulatory inspection.

Arrange your non-binding consultation on the CE marking of your machines.

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for CE-Conformity