Certification of machinery - key information and practical tips for manufacturers and users

Estimated reading time: approx. 10 minutes

TL;DR:

• Machine certification confirms that the equipment complies with the Machinery Directive 2006/42/EC and safety standards.
• It is the responsibility of the manufacturer or importer to comply with legal requirements, and a lack of certification can mean penalties and risks for workers.
• The conformity assessment process includes, among other things, risk analysis, technical documentation and CE marking.
• When extending or modernising machinery, compliance with legal requirements must be re-verified.
• Working with experts (e.g. Michale Automatics) streamlines the certification process and minimises the risk of errors.

Table of contents

• What is machine certification and why is it so important?
• Legal basis - Machinery Directive 2006/42/EC
• Who is responsible for machine certification?
• What is the step-by-step process of machine certification?
• Key challenges and issues in machinery certification
• Is it worth using specialists?
• Certification of machinery and robotisation and automation
• Impact of certification on subsequent operation of machinery
• Certification of machinery in practice - example situations
• Costs and benefits of machine certification
• The most common errors during machine certification
• How does machine certification affect the planning of new investments?
• Compliance assessment support - what does collaboration with Michale Automatics look like?
• Overview of important elements of machine certification - in summary form
• Practical tips for companies planning machine certification
• Summary
• FAQ

Introduction

The certification of machinery is today one of the most important elements in the marketing of equipment in the European Union. It is what confirms the conformity of machinery with the provisions of the Machinery Directive 2006/42/EC. For entrepreneurs in the manufacturing industry, as well as for project managers and company owners, any mistake at the certification stage can mean not only an administrative penalty, but also a real threat to human safety and the continuity of plant operations.

In the following article, prepared by the Michale Automation team, we look at the most important aspects of machine certification and show why compliance with safety standards is so important for modern organisations. Readers will learn exactly what the whole process entails, how to carry out a risk assessment correctly and how to link certification to planned automation or robotisation developments.

With this knowledge, you will gain an insight into the key legal and technical elements, as well as practical tips to help you ensure that your machinery is marketed or used in a completely legal and safe manner.

What is machine certification and why is it so important?

Machine certification is the official confirmation that equipment meets the requirements set out in European safety regulations - mainly the Machinery Directive 2006/42/EC. In Polish reality, it is primarily a confirmation of compliance with national regulations and standards harmonised with the directive.

For a manufacturer or a person who is placing machinery on the EU market for the first time (e.g. importing from a non-EU country), the certification process is mandatory. Machinery that has not undergone conformity assessment, does not have a CE marking and lacks an EC Declaration of Conformity cannot be legally sold or used.

Human safety is an equally important aspect. Machines without proper labelling and approval are not guaranteed to meet stringent standards. As a result, they can be a potential source of mishaps and legal consequences for the company. Certification prevents these scenarios by ensuring that equipment is equipped with the protective measures and safeguards required by law.

Legal basis - Machinery Directive 2006/42/EC

The most important document regulating the requirements for machinery in the countries of the European Union is the Machinery Directive 2006/42/EC. It defines the so-called essential health and safety requirements that any machine put into service or placed on the market in the Community must meet.

The Machinery Directive contains, inter alia:

• Definitions of what should be considered as machinery and in which cases conformity assessment should be carried out.
• Health and safety requirements.
• Description of conformity assessment procedures (depending on the type of machinery).
• Technical documentation requirements.

It is also important to remember that the Machinery Directive does not operate in a vacuum. There are other regulations (e.g. on electromagnetic compatibility or pressure equipment) that may overlap with the scope of the Machinery Directive. Overall, however, it is the focal point from which any manufacturer should start when planning to put machinery on the market.

Who is responsible for machine certification?

Under current legislation, the responsibility for carrying out the certification process lies with the manufacturer of the machine or the importer (if the manufacturer is based outside the European Union). It is these entities that must demonstrate that the equipment has been designed and manufactured in accordance with the directives and meets the requirements in the area of safety.

As part of these obligations, the manufacturer or importer:

• Identifies all key regulations and standards applicable to a specific type of machine.
• Carries out a risk assessment and verifies (or has experts do so) that the design complies with legal requirements.
• Draws up technical documentation and keeps it in the EU if necessary (if a non-EU manufacturer appoints a so-called authorised representative).
• It makes the CE marking on the nameplate and issues an EC Declaration of Conformity, certifying compliance with the requirements of the Machinery Directive.

Additional attention should be paid to upgrades or modifications that may alter the technical parameters of the machine. If the nature of the changes is such that the machine starts to meet the criteria for 'new machinery', then it is necessary to go through the conformity assessment procedure again.

What is the step-by-step process of machine certification?

1. Identification of regulations and standards

The first step is to determine which directives and harmonised standards apply to the machine in question. For most industrial equipment, this will be the Machinery Directive 2006/42/EC, and often related standards (e.g. ISO 12100, ISO 13849, etc.).

2 Risk analysis

This is the key moment when the possible risks that may arise from the use of the machine are identified and risk-reducing measures are implemented (e.g. the use of additional guards, interlocks, automation solutions to prevent uncontrolled movements, etc.).

3. development of technical documentation

Full documentation must be prepared, including operating descriptions, electrical and pneumatic diagrams, component lists, operating instructions, replacement drawings, safety test results, records of the risk analysis process. The documentation must be kept for a specified period of time (usually at least 10 years after the machine is released).

4. CE marking and issuing of the EC Declaration of Conformity

Once the conformity assessment has been carried out, the manufacturer affixes the CE marking to the machine and then issues an EC Declaration of Conformity, confirming compliance with the requirements of the Directives. This document must accompany the machine when it is sold or handed over to the end user.

Key challenges and issues in machinery certification

Despite clearly defined procedures and standards, there is no shortage of difficulties in practice. Here are the most important ones:

• Ignorance of legal requirements: This is especially true for smaller companies that do not have specialised engineering departments. This can result in shortcomings that later require costly corrections.
• Errors in risk analysis: Failure to recognise potential hazards means failing to provide adequate safeguards and, ultimately, not allowing the machine to be used.
• Complex modifications: Machine upgrades, especially if they affect the basic functions or parameters of the machine, often require almost the entire procedure from scratch.
• Incomplete or poorly organised documentation: Without consistent technical documentation, even the best machine can be found to be non-compliant.

Is it worth using specialists?

Companies in the mechanical engineering sector, including Michale Automatics, with their experience in developing and implementing equipment for the market, often help entrepreneurs with the certification process. Working with external experts minimises the risk of errors and allows the focus to be on production and integration. Examples of support include:

• Conceptual consultation at the design stage.
• Comprehensive risk analysis of machinery and production lines.
• Preparation of the documentation necessary for issuing the EC Declaration of Conformity.
• Development of safety solutions (guards, safety systems, programmable control systems).

Michale Automation is concerned with the safety and legality of the use of the machines it designs. As a company that also specialises in the creation of robotic workstations and entire production lines, it is able to anticipate potential risks even at the design stage.

Certification of machinery and robotisation and automation

Today's factories and industrial plants are increasingly turning to robotisation and automation to increase process efficiency and precision. However, machines integrated with industrial robots or cobots (cobots) are also subject to the Machinery Directive.

Every robotic workstation - whether it is a welding line, a packaging line or an assembly task - must be equipped with appropriate safety features (light curtains, physical barriers, emergency stop systems, etc.). As a result, when planning automation, it is worth discussing the certification scenario at the outset.

If you would like to find out more about the robotisation services on offer, we encourage you to visit the website: Robotics services in Michale Automation

Solutions such as SIASUN robots, which Michale Automatika distributes in Poland, provide an advanced level of automation. However, even then, it is always necessary to check that the entire station and work line meets the requirements of the Machinery Directive.

Impact of certification on subsequent operation of machinery

Employer's liability

If you are in charge of a production facility and operate machinery, it is your responsibility to ensure a safe working environment. This means that the mere fact that you have the CE marking does not absolve you from the obligation to regularly check the condition of the equipment, service it, follow the manufacturer's recommendations and train your employees.

Periodic audits and maintenance

According to Polish and European law, the employer must monitor the safety condition of machinery throughout its lifetime. If a new line contains robotic elements, it is worthwhile to take care of specialised maintenance and servicing. For more information on maintaining production workstations, click here: Service and maintenance stands

Particularly in the case of machines that passed certification several years earlier, technological changes may require checking additional issues - for example, whether modifications to the controls have affected the original risk assessment.

Certification of machinery in practice - example situations

Newly designed production line

Company X decided to launch a new production line using industrial robots. All the equipment was designed and manufactured by the Michale Automatika team and then integrated into the existing plant equipment. Before the line reached the end user, Michale Automatika carried out a risk analysis, implemented safety measures (guards, sensors, emergency buttons) and coordinated the entire conformity assessment process on behalf of the client. As a result, the machines were CE-marked as one consistent system.

Modification of an existing machine

Company Y decided to upgrade an older machine model to increase the speed and precision of its production processes. After adding new control modules and installing a vision system, it was determined that the existing risk assessment was no longer valid. A further revision was required, taking into account the extent of the modifications and the change in parameters. The end result was revised documentation and a new EC Declaration of Conformity.

Machines imported from outside the EU

Entity Z, importing machinery from the Far East, was obliged to carry out a conformity assessment of the machinery before reselling it in Poland. As the manufacturer of the machinery was not based in the EU, the importer became the entity responsible for carrying out the certification. Due to the lack of technical documentation in Polish and insufficient safeguards, it was necessary to modify and fill in the gaps in the documentation.

Costs and benefits of machine certification

Cost characteristics

• Design costs: Design improvements, introduction of better materials and safety features, safety testing.
• Consultancy costs: Assistance from external experts for risk analysis or documentation creation.
• Time costs: The project can get longer if non-compliant machine components come to light during the work.

Long-term benefits

• Legality and no sanctions: Certified machines meet EU standards, preventing administrative penalties and the risk of production stops.
• Greater safety: Fewer accidents mean lower costs in terms of insurance, absenteeism and potential claims.
• Customer confidence: The ability to offer CE-certified machines and lines is a competitive advantage.
• Scalability of the process: Once a company has mastered the certification procedure, it is easier for it to design further machines and modifications.

The most common errors during machine certification

1. insufficient risk analysis.
2. the late inclusion of safety experts in the design of the machine - often key comments are made when the line is already 90% complete.
3. outdated documentation.
4 Underestimation of the costs and time needed to implement the requirements of the Machinery Directive.
5. omitting or downplaying the impact assessment of even minor modifications.

How does machine certification affect the planning of new investments?

Machine certification and its costs should be built into the design phase of any new investment. This applies not only to building machines from scratch, but also to implementing robotisation processes for repetitive production. If you would like to find out how robotisation can improve processes while maintaining the highest safety standards, visit: Robotisation of repetitive production

Investment planning that takes into account legal requirements and safety standards translates into a lower risk of line downtime, restrictions on access to qualified personnel or financial penalties.

Compliance assessment support - what does collaboration with Michale Automatics look like?

At Michale Automatika, we focus on ensuring that the machine design and integration process complies with the Machinery Directive from the very first stages of the engineers' work. As a result:

• We minimise risk by providing comprehensive industrial automation solutions.
• We work with the client to help them select security solutions for their specific application.
• We focus on documentation transparency - we provide all instructions and drawings to customers so that, in the event of changes or inspections, there is no doubt that the machines are legal and safe.

We invite you to learn more about our full range of services for the construction and certification of automated workstations: Our services

Overview of important elements of machine certification - in summary form

• Machinery Directive 2006/42/EC: The main document required for conformity assessment of machinery in the EU.
• Risk analysis: A starting point for identifying potential risks and necessary safeguards.
• Technical documentation: The basis for issuing an EC Declaration of Conformity. It should include, among other things, diagrams, parts lists, operating instructions, test reports.
• CE marking: Final confirmation that the machine is ready for the EU market.
• The role of the producer/importer: This entity is responsible for the proper conduct of the procedure.
• Need for recertification: For major modifications, there is an obligation to go through the procedure anew.
• Expert service: Working with professionals (such as Michale Automatics) speeds up and simplifies certification.

Practical tips for companies planning machine certification

1. start with a legislative analysis
Check which regulations apply to your type of machinery before you start your design work. Also take into account possible conflicts with other directives - e.g. low voltage (LVD) or electromagnetic compatibility (EMC).

2. Regularly review safety progress
The certification process is worth including in the project schedule. Scheduling regular meetings with security engineers reduces the risk of painful revisions at the end of the work.

3. document each stage
Create detailed documentation: assembly photos, copies of component declarations of conformity, test notes, health and safety instructions. This meticulousness will speed up the conformity assessment procedure and avoid documentation gaps.

4. rely on service and condition monitoring of machines
Remember that certification does not end when the Declaration of Conformity is issued. Maintenance and periodic audits are needed for the equipment to remain safe.

5. consult experienced professionals
If you are creating complex process lines - especially involving industrial robots - consider working with teams that know the subject from practice. This could be Michale Automation, for example, which has experience in building machines and production lines, including robotic solutions.

Summary

Machinery certification is the foundation for the legal and safe operation of equipment in the European Union. Whether you are bringing brand new machinery onto the market, modifying existing solutions or importing equipment from outside the EU, you must always ensure that the Machinery Directive 2006/42/EC is assessed.

The key benefits associated with certification are:

• Ensuring employee safety and minimising the risk of accidents.
• Avoiding costly sanctions and legal problems.
• Strengthening the credibility of the company.
• Facilitate the development of new system designs and production lines with the knowledge gained on safety standards.

We encourage:

• Check the details of our offer for the modernisation and construction of robotic workstations: Service and maintenance stands.
• Preparing the company for comprehensive robotisation with the highest safety standards - more information: Robotisation of repetitive production.
• Make the article accessible to those who may need to know about the machinery certification process.

Machine certification should not be seen as a formality or an unpleasant chore. It is an investment in the safety, growth and reputation of your company. Conscious planning of this process, backed up by expert knowledge and experience, protects your company and employees from unnecessary risks.

If you would like more details on machine integration, production line design or are planning robotic workstations, please contact us via our website. The Michale Automation team will be happy to help you choose the optimum technical solutions and ensure compliance with legal requirements.

Thank you for reading this article. We hope that the knowledge you have gained will translate into safe and effective machine implementations in your company. If you have any questions, please feel free to comment or contact us - we will be happy to dispel any doubts!

FAQ

Does the certification of machinery also apply to equipment used only on site?
Yes. Even if the machine does not leave the plant, it should comply with safety requirements so that it does not pose risks to workers and does not expose the company to legal sanctions.

What are the company's penalties for failing to certify machinery?
This can result in a ban on further use of the equipment, financial penalties and, in the case of accidents at work, criminal consequences and compensation claims.

Do all modifications to the machine require a reassessment of conformity?
Not every modification necessitates re-certification, but significant changes in design or functionality that affect safety may trigger it. When in doubt, it is worth consulting a specialist.

How long does the machine certification process take?
The time depends on the complexity of the device and the completeness of the documentation. It can be several weeks, but with larger systems even several months.

Where can I find support for robotisation and certification?
You can turn to the Michale Automation team, which offers both machine design and integration as well as expert advice on conformity assessment.