CE Marking for Machinery: Requirements, Procedures, and Documentation in Control Cabinet Manufacturing

As a manufacturer of switchgear with over 50 years of experience, we’ve compiled everything you need to know about the CE marking of machinery on this page—explained in an easy-to-understand way and organized with practical applications in mind.

  • ✓CE Marking Explained Simply
    Legal basis, mandatory requirements, and scope clearly outlined
  • ✓Safety & Legal Certainty
    Properly Implementing Conformity Assessment, Technical Documentation, and the Declaration of Incorporation
  • ✓Practical knowledge from 50 years of experience
    Directly from our switchgear experts

For design engineers and procurement professionals in the plant and machinery engineering sector, the CE mark on a machine does not indicate external certification by an independent body, but rather a self-declaration by the manufacturer based on a conformity assessment procedure that includes the evaluation of all relevant risks, in accordance with the Machinery Directive 2006/42/EC, implemented in Germany by the 9th ProdSV, the so-called Machinery Ordinance. The CE marking on a machine documents compliance with all applicable EU legal requirements and is a mandatory prerequisite for placing the machine on the market, making it available on the market, and putting it into service within the EU and EEA single markets. This obligation typically arises from the manufacture of new machinery, self-construction, a significant modification of an existing machine, the interconnection of multiple machines into a complete system, or importation from third countries. The following sections of this page cover the legal basis in detail, define the cases where this obligation applies, identify the respective responsible parties, describe the conformity assessment process, and outline the documentation required in control panel manufacturing—including the ECDeclaration of Conformity and Declaration of Incorporation—and outline the transition to the future EU Machinery Regulation (EU) 2023/1230, which will replace the current Directive as of January 20, 2027. This page is categorized under the Control Panel Construction Standards Hub.

Table of Contents

Your contact persons

Dirk Schütz

Dirk Schütz

Head of Switchgear Construction Department

T +49 2261 987-405
E-Mail | vCard

Felix Trommershausen

Felix Trommershausen

Sales Switchgear Construction

T +49 2261 987-413
E-Mail | Linkedin | vCard

Legal Basis and Significance of the CE Mark

On a desk lie the EU Machinery Directive and a laptop with a checklist for CE marking of machinery.
CE: The Key to the Free Movement of Goods

The Machinery Directive is the core piece of legislation governing machinery; however, it is supplemented by other EU directives whenever a product has additional features: If a machine contains electrical equipment operating in the low-voltage range between 50 V AC and 1,000 V AC or 75 V DC and 1,500 V DC, the Low-Voltage Directive 2014/35/EU also applies, while the EMC Directive 2014/30/EU governs electromagnetic compatibility, and the ATEX Product Directive 2014/34/EU applies when the machine is used in potentially explosive atmospheres. At the national level, the Product Safety Act complements these European requirements and establishes market surveillance. From a legal perspective, the CE marking is not a test label, but rather a declaration of conformity by the manufacturer addressed to the market surveillance authorities, which enables the free movement of goods within the internal market without requiring an external inspection each time a product is placed on the market. This is to be distinguished from voluntary test marks such as GS or DGUV-Test, which certify an additional, independent safety assessment but neither replace nor render the statutory CE requirement superfluous. In practice, the term “CE certification” persists—in fact, this is not certification in the legal sense, but rather a self-declaration made under the manufacturer’s own responsibility.

Machinery Directive 2006/42/EC and Essential Safety Requirements

A man in a blue work coat is reviewing technical drawings and a checklist at his desk.
Design Safely, Place on the Market in Compliance

The structure of the Machinery Directive is divided into the scope of application, which includes a definition of the term “machinery”; the essential health and safety requirements set forth in Annex I; and the conformity assessment procedures outlined in Annexes VIII through X, with Annex IV containing a list of particularly hazardous machinery for which the involvement of a Notified Body is mandatory. Annex I itself is divided into general principles and chapters on mechanical, electrical, and ergonomic hazards, supplemented by specific requirements for individual categories of machinery. Before placing the machinery on the market, the manufacturer must comply with all relevant requirements in Annex I; the interpretation of these requirements is always based on the current state of the art, as no rigid technical values are specified in this Annex itself. The presumption of conformity simplifies the process: If the manufacturer applies harmonized standards whose references are published in the Official Journal of the EU—such as DIN EN 60204-1 as a harmonized standard for Directive 2006/42/EC—the relevant safety requirement is deemed to have been met. The application of these standards remains formally voluntary, while compliance with the underlying safety objectives remains mandatory and can, in principle, also be demonstrated through other equivalent technical solutions.

Low-Voltage Directive and EMC Directive in Control Panel Construction

A man in work clothes is using a multimeter to check the wiring in an open control cabinet.
Multiple Directives, Seamless Compliance

The electrical equipment of a machine is subject to the safety objectives of the Low-Voltage Directive in addition to the Machinery Directive, since these legal acts may apply concurrently and the EC Declaration of Conformity must specify all relevant directives. If a switchgear assembly is placed on the market independently—that is, separately from the machine—the Low-Voltage Directive applies directly—particularly if the assembly itself does not contain any separate safety components as defined by the Machinery Directive. In addition, the EMC Directive 2014/30/EU regulates electromagnetic emissions and immunity, as specified, among other things, by the harmonized DIN EN 61000 series of standards, so that both directives regularly apply jointly to electrical equipment used in control cabinet construction. The key product standard for the electrical equipment of machines is DIN EN 60204-1 in the version effective since June 2019; it applies to rated voltages up to 1,000 V AC or up to 1,500 V DC and stipulates, among other things, that outlet circuits up to 20 A must generally be equipped with residual-current devices (RCDs) rated at a maximum of 30 mA. For self-contained low-voltage switchgear assemblies, the DIN EN 61439 series of standards is also applicable, covering rated voltages up to 1,000 V AC or 1,500 V DC. The application of these harmonized standards establishes a presumption of conformity with the relevant directives and thereby facilitates the provision of evidence in the conformity assessment procedure.

Requirements for the Affixing and Design of the CE Marking

A metal plate screwed into the control cabinet lists the manufacturer, model, serial number, year of manufacture, and CE marking.
CE Marking: visible, permanent, compliant with regulations

In addition to requiring compliance with the content, the Machinery Directive also specifies in detail the formal requirements for affixing the CE marking: It must be visibly, legibly, and permanently affixed—in practice, usually on the nameplate, immediately next to the manufacturer’s details, the machine’s designation, serial or model number, and year of manufacture. The graphic design must follow fixed proportions and have a minimum height of 5 millimeters; if the mark is reduced or enlarged, the specified proportions must be strictly maintained. Any marking that could be confused with the CE marking in terms of meaning or typeface is prohibited, as this would mislead market surveillance authorities and users regarding actual conformity. If a Notified Body was involved in the conformity assessment procedure—for example, for Annex IV machines—the CE mark must also include the body’s identification number. Before placing the product on the market, it must also be verified whether a complete machine exists at all: Partly completed machines may not bear the CE marking in accordance with the Machinery Directive, but must instead be accompanied by a Declaration of Incorporation.

When a CE Marking Is Required for Machinery

A machine shop shows automated production lines, several robotic arms, and open electrical cabinets as seen from above.
CE Marking Requirement: These Factors Are Decisive

Whether a machine requires a CE marking is determined based on several criteria that can be summarized as follows: The obligation arises when a complete machine is newly manufactured, as well as in the case of self-built machines or special-purpose machines—even if these are used exclusively within the company’s own operations and are never transferred to third parties. The same applies to the import of machinery from third countries into the EEA, to the integration of multiple individual machines into a complete system, and to substantial modifications to an existing system. Legally, a distinction must be made between the initial placing on the market—that is, the transfer to a third party, whether for consideration or free of charge—and the mere commissioning within one’s own company; however, both processes trigger obligations under the provisions governing placing on the market, regardless of each other. In contrast, used machinery that has already been placed on the market for the first time within the EEA and remains unchanged upon resale does not require a new CE marking, as there is no substantial modification within the meaning of the Machinery Directive in such cases.

New production, in-house manufacturing, and imports from third countries

In a factory, a welder joins metal profiles together to form a frame, while bright sparks fly.
Whoever manufactures or imports a product bears the responsibility

When manufacturing a new machine, the manufacturer bears full responsibility for conformity assessment, technical documentation, and CE marking, regardless of whether the machine is later sold or used exclusively within the company. Even building a custom machine for one’s own production facility triggers the same obligations, as the Machinery Directive does not distinguish based on whether a machine is supplied to third parties. When importing from third countries, the importer becomes the responsible economic operator with regard to placing the machine on the market and must verify, prior to making it available on the EEA market, that conformity assessment, technical documentation, and the EC Declaration of Conformity are in fact available. If this documentation is missing or if the importer acts under its own name, it assumes all manufacturer obligations in full, as if it had manufactured the machine itself. In contrast, pure distributors are subject only to limited verification and due diligence obligations, as they merely pass on the product unchanged without acting as a manufacturer or importer. In practice, this distinction often determines who, in cases of doubt, is held accountable by market surveillance authorities.

Linking Multiple Machines to Form a Single System

Several orange industrial robots are standing next to an open control cabinet on a series of interconnected conveyor belts.
Many machines, a shared responsibility

If several individual machines and partly completed machines are assembled and controlled in such a way that a functional relationship is established—for example, through a common material flow, a centralized control system, and shared safety functions, this combination is considered a “group of machines” within the meaning of the Machinery Directive 2006/42/EC. A key distinguishing criterion here is the system-wide emergency stop concept: DIN EN 60204-1 defines stop categories 0, 1, and 2 for this purpose, which must be uniformly effective across all component machines in interlinked systems and must not be considered in isolation for each individual machine. If such a system as a whole exists, a separate risk assessment, a separate EC Declaration of Conformity, and a separate CE marking are required for the system as a whole prior to placing it on the market; while the existing CE markings on the individual machines remain valid, they do not replace the overarching assessment of the system as a whole. The interfaces of the overarching control system and the central control cabinet are of particular importance here, as this is where all safety-related signals from the component machines converge and must be coordinated.

Partly Completed Machinery and the Declaration of Incorporation

An open gearbox with several gears, shafts, a motor, and visible wiring sits on a workbench.
Almost a machine—but still without a CE mark

Not every assembly used in plant engineering already meets the definition of a complete machine under the Machinery Directive 2006/42/EC. According to Article 2(g), an incomplete machine is defined as an assembly that almost constitutes a machine but cannot perform a specific function on its own because it lacks, for example, a drive, control logic, or integration into a specific process. Such assemblies may not bear the CE marking required by the Machinery Directive; instead, a Declaration of Incorporation in accordance with Annex II, Section 1(b), and assembly instructions in accordance with Annex VI must be prepared, supplemented by specific technical documentation in accordance with Annex VII, Part B. The Declaration of Incorporation specifies which essential requirements from Annex I have already been met and discloses which safety objectives the manufacturer of the final machine still needs to address. In practice, this often applies to control cabinets and sub-assemblies that are manufactured separately from the eventual complete machine and are only finally integrated at the plant manufacturer’s facility.

Significant modifications to existing machinery

A technician is working on an open electrical cabinet filled with densely packed cables, contactors, and a measuring device.
Retrofit or New Machine? The Legal Turning Point

The most relevant conflict in practice concerns modifications, retrofits, and performance upgrades to existing machines, as the line between permissible maintenance and a reassessment requiring CE marking is often unclear in these cases. According to the interpretation, a substantial change exists if an additional risk arises or an existing risk is increased that was not the basis of the original conformity assessment—for example, due to a modified control function, higher drive power, or a change in the type of use. If this is the case, the machine is legally considered to be newly manufactured, with the result that the party making the changes assumes the role of the manufacturer and must conduct a new risk assessment, conformity assessment, and CE marking in accordance with 2006/42/EC. This must be distinguished from mere maintenance, repair, and the replacement of identical spare parts, as these measures do not introduce new hazards and do not affect the original conformity status. The BMAS interpretation paper on substantial modifications to machinery serves as a basis for uniform assessment and is used as a recognized interpretive guide for operators, designers, and market surveillance authorities.

Criteria: new hazard, increased risk, change in intended use

Two experts are examining circuit diagrams in a workshop next to an open control cabinet and measuring instruments.
Three Questions That Will Determine Whether a New Exam Is Administered

Whether a significant change has actually occurred can be determined using a three-step assessment process based on the definition from the previous section. First, it must be determined whether the modification creates a new hazard or increases an existing risk. If the answer is yes, the second step is to determine whether the increased risk can be reduced back to its original level through simple protective measures without requiring a complete reassessment. Third, it must be assessed whether the intended use, function, or performance of the machine changes significantly. Typical examples from plant engineering include a control system retrofit with a new safety control system, an increase in feed rate or rotational speed, the retrofitting of an additional handling module, the reprogramming of a robot, or the expansion of the workspace. Even if the assessment ultimately reveals no significant change, this evaluation should be documented in order to provide market surveillance authorities with verifiable evidence of the assessment made.

Operator Responsibilities Under the Industrial Safety Regulation

An employee wearing a hard hat and a high-visibility vest is holding a clipboard next to an industrial machine.
From a Safe Product to Safe Operation

The operator’s obligation under the Occupational Safety and Health Act and the Industrial Safety Ordinance must be distinguished from the issue of a substantial change. While the risk assessment under the Machinery Directive, from the manufacturer’s perspective, concerns the safety of the machine prior to its placing on the market, the hazard assessment under the Industrial Safety Ordinance focuses on the specific use of the machine in the workplace: the work environment, employee qualifications, as well as inspection intervals and periodic inspections by qualified persons. These inspections build upon the initial inspection in accordance with DGUV Regulation 3, whereby the inspection intervals for stationary equipment are based on a four-year period, unless the hazard assessment justifies a shorter interval. If an operator makes a significant modification to an existing machine, they assume both roles simultaneously: They remain the operator with an ongoing obligation to conduct risk assessments and periodic inspections, but at the same time assume all manufacturer obligations under the Machinery Directive, including technical documentation and the preparation of a new EC Declaration of Conformity. This dual role assignment is often overlooked in practice, even though it determines who is actually liable.

Procedure for the Conformity Assessment Process

Circuit diagrams lie on a table next to a laptop and a control module; a factory floor is visible in the background.
From Product Concept to the CE Mark

The conformity assessment procedure essentially follows a fixed sequence of steps, even though its practical implementation may vary depending on the machine. The starting point is the determination of the intended use and any reasonably foreseeable misuse, followed by the identification of all applicable legal requirements and the actual risk assessment in accordance with EN ISO 12100. On this basis, the manufacturer selects appropriate harmonized standards and implements protective measures according to the three-step approach: inherently safe design, followed by technical protective measures, and finally user information. Next, it must be determined which procedure under Annexes VIII through X applies before the technical documentation in accordance with Annex VII and the operating instructions are prepared. The process concludes with the issuance of the Declaration of Conformity and the affixing of the CE mark. Important for practical application: This sequence is not a rigid, linear process but rather an iterative one—if, for example, a drive design or control function changes during the design phase, the risk assessment must be repeated and, if necessary, adjusted.

Risk Assessment According to EN ISO 12100

An employee is inspecting an open control cabinet with a tablet; a warning sign indicates the presence of electrical voltage.
Identify risks before they become a problem

The risk assessment according to DIN EN ISO 12100 forms the methodological core of the evaluation procedure described above and is itself designed as an iterative process. The first step is to define the machine’s boundaries—that is, its operational, spatial, temporal, and environmental boundaries—followed by the identification of hazards across all life cycle phases, including transport, assembly, setup, maintenance, and disposal. This is followed by risk estimation and risk assessment, from which the specific need for risk reduction is derived. A fixed hierarchy applies to the selection of protective measures: inherent safety in design takes precedence, followed by technical protective measures, including supplementary protective devices, and finally user information. It should be emphasized that the application of standards does not replace the risk assessment but merely supports its implementation; the results are a mandatory component of the technical documentation. For specific safety functions, EN ISO 12100—as a Type A standard—refers to relevant Type B and Type C standards, such as EN ISO 13849-1 for safety-related parts of control systems.

Notified Body and Annex IV Machinery

Two men are inspecting an industrial machine with a protective guard; one is shining a light inside, while the other is holding a tablet.
Appendix IV determines the test procedure

The key factor in selecting the conformity assessment procedure described in the previous section is whether a machine is listed in Annex IV of the Machinery Directive 2006/42/EC. For all machines not listed there, internal production control in accordance with Annex VIII—which the manufacturer carries out under its own responsibility—is sufficient, and no external inspection is required. The situation is different for Annex IV machines, which include, for example, presses, circular saws, injection molding machines, or certain lifting devices: If the relevant harmonized standards have been fully applied, there is a choice between several procedures; if they have not been applied or have not been applied in full, a Notified Body must be involved, either through the EC type examination under Annex IX or through the comprehensive quality assurance system under Annex X. The European NANDO database can be consulted to determine which bodies are notified for which procedures and which product categories. If a Notified Body was involved in the conformity assessment procedure, its identification number appears next to the CE mark on the nameplate.

Electrical Safety Certifications in Accordance with DIN EN 60204-1 and DIN EN 61439

A technician is using a handheld meter to measure the wiring in an open control cabinet for CE marking.
Thoroughly Tested: Documentation for Each Stop Category

At the documentation level, DIN EN 60204-1 “Safety of Machinery – Electrical Equipment of Machinery,” in its sixth edition (VDE 0113-1) effective as of June 1, 2019, specifies the mandatory electrical testing requirements and thereby supplements the safety objectives of the Low-Voltage Directive at the level of electrical equipment. According to Section 18, during installation, modification, and after repair, the following tests must be performed, among others: continuity testing of the protective conductor system, insulation resistance measurement, voltage testing, residual voltage testing, and functional testing of the safety and emergency stop functions. The emergency stop concept is based on stop categories 0, 1, and 2, which distinguish between uncontrolled immediate stop, controlled stop followed by power disconnection, and controlled stop while power remains connected. For switchgear assemblies, the DIN EN 61439-1 series of standards additionally requires a type test: Verification of thermal stability and short-circuit resistance is performed either through testing, comparison with a reference design, or calculation, supplemented by an individual verification test for each manufactured cabinet. In practice, CE-compliant design is also reflected in specific implementation details: continuous protection against accidental contact and safe clearances, strain relief at all cable entries, distinctive wire colors and labeling in accordance with VDE 0100-510, as well as the consistent separation of power and control circuits—requirements that, as experience has shown, can only be reliably implemented through consistent planning from the outset and not through retroactive adjustments.

Technical Documentation in Control Panel Construction

An open control cabinet with wired drives stands next to technical manuals and wiring diagrams.
CE Documentation: Ten Years of Mandatory Compliance, Zero Leeway

With regard to the interface with control cabinet construction, Annex VII of the Machinery Directive specifies the technical documentation, which includes a general arrangement drawing of the cabinet, complete wiring diagrams, the risk assessment documentation, and a list of the standards applied. For control cabinet construction, it is also recommended to include a bill of materials listing the installed components to facilitate traceability in the event of an inspection. In addition, operating instructions must be prepared that describe the assembly, operation, maintenance, and permissible operating conditions. Depending on whether the product is a complete machine or merely an incomplete assembly, this is followed by the EC Declaration of Conformity or the Declaration of Incorporation. At the verification level, the calculation and documentation of the short-circuit current in accordance with DIN EN 61439, as amended in 2019, are mandatory; and temperature verification in accordance with IEC 61439 or IEC 60890 is also required to prevent overheating during operation. Electrical tests in accordance with Section 18 of DIN EN 60204-1 must be performed during installation and after any modifications or repairs, and the results must also be recorded. The manufacturer must keep all technical documentation available to market surveillance authorities for ten years from the last date of manufacture; a permanent paper copy is not required, provided the documents can be submitted within a reasonable period of time.

Technical Documentation: Circuit Diagrams, General Arrangement Drawing, and List of Standards

Circuit diagrams and a multimeter are lying on a workbench next to an open electrical cabinet containing wiring.
Technical documentation that makes safety transparent

As part of the technical documentation required under Annex VII, Part A, the electrical documentation must include, in addition to the components already mentioned, a general arrangement drawing of the machine with details on the protective devices used, as well as complete circuit diagrams and terminal diagrams, supplemented by assembly and installation drawings of the control cabinet. In addition, there are bills of materials, equipment data sheets, as well as calculations and test results related to the tests required under Section 18 of DIN EN 60204-1: These include insulation resistance measurement, protective conductor resistance measurement, functional testing of the protective devices, and testing of the emergency stop function. Also included in the documentation are the risk assessment documents, the list of applied harmonized standards and other technical specifications, as well as evidence of the implemented safety functions. In practice, these documents are usually maintained as CAD and E-CAE documentation, whereby revision statuses and change tracking must remain traceable so that the documents always reflect the actual condition of the system as delivered. This detailed documentation also serves as the foundation for the operating instructions, as the content of both types of documentation must be consistent with one another.

Operating Instructions and Requirements for User Information

An employee is reviewing an open circuit diagram at a machine control panel in a factory.
Unlocking your device safely starts with the right instructions

According to Annex I, Section 1.7.4 of the Machinery Directive, every machine must be delivered with an original instruction manual in an official language of the country of use, containing information on the intended use, residual risks, transport, assembly, commissioning, operation, maintenance, and decommissioning; in addition, information on noise emissions must be included. The instruction manual must be supplied with the machine and may not be replaced by separate brief information sheets. For control panel construction, this results in specific requirements: instructions on safe disconnection, residual voltages on capacitors or DC links, and work on live circuits, which must be reserved exclusively for a qualified electrician using appropriate measuring and testing equipment. In addition, the documentation must include information on periodic inspection intervals as well as clear spare part identification so that safety-critical components can be replaced with identical ones. Warning labels and the labeling of control elements must correspond to the instruction manual so that users can clearly identify hazardous areas and functions. If the instructions are missing when the machine is placed on the market or are not available in the required language version, the machine is considered unfit for sale, regardless of its other technical specifications.

EC Declaration of Conformity and Distinction from the Declaration of Incorporation

A hand is signing a declaration of conformity at a desk, with open electrical cabinets visible in the background.
Compliance or Installation? The Crucial Difference

In a direct comparison, the two documents differ significantly in scope and substance. The EC Declaration of Conformity pursuant to Annex II, Section 1A contains the name and address of the manufacturer and the person authorized to prepare the documentation, the unambiguous identification of the machine including its serial number, a reference to all applicable directives and standards that have been met, where applicable, details regarding the involved Notified Body, as well as the place, date, and legally binding signature of an authorized representative. In contrast, the Declaration of Incorporation pursuant to Annex II, Section 1B is intentionally more concise: It merely confirms compliance with certain essential requirements from Annex I, includes a commitment to submit specific technical documentation to national authorities upon justified request, and expressly prohibits the putting into service of the subassembly until the final machine as a whole has been declared compliant. For plant engineering, this has a clear implication: Both documents must accompany each shipment so that market surveillance authorities and downstream manufacturers can fully trace the conformity status.

Transition to the EU Machinery Regulation (EU) 2023/1230

Three men are sitting at a table discussing circuit diagrams and the topic of “CE marking for machinery”; EU documents are spread out in front of them.
New Rules, New Standards Starting in 2027

With its entry into force on July 19, 2023, the transition period for the future EU Machinery Regulation (EU) 2023/1230, which will fully replace the Machinery Directive 2006/42/EC as of January 20, 2027. Unlike a directive, a regulation does not require national implementation but applies directly and uniformly in all Member States, meaning that in the future there will no longer be an intervening national implementing law. The date of placing on the market is the sole determining factor for applicability: If a machine is placed on the market before the cut-off date, it will continue to be assessed for conformity under the previous Machinery Directive even after that date, while machines placed on the market later will be subject to the new regulation. This cut-off date provision is particularly relevant in practice for projects with long lead times and delivery periods—such as in custom machine manufacturing—as well as for framework agreements and specifications that span several years: Engineers and procurement specialists should determine early on which legal framework applies to the respective delivery in order to avoid last-minute adjustments immediately before the cut-off date.

New Developments: High-Risk Machines, Cybersecurity, and Software

A technician is holding a device labeled “CYBERSECURITY” inside an open electrical cabinet.
High-Risk Machinery: Safety Goes Digital

In terms of content, the EU Machinery Regulation (EU) 2023/1230 introduces a fundamental restructuring of the risk classification system compared to the previous Machinery Directive: The previous Annex IV is replaced by Annex I, which consists of two parts; for certain high-risk categories, it will be mandatory to involve a Notified Body in the future. New requirements have also been added regarding cybersecurity and protection against tampering with safety-critical functions, the evaluation of software updates, and machines with self-learning or AI-supported behavior. These regulations are supplemented by provisions on autonomous and networked systems as well as on human-robot collaboration, which were not addressed in this form in the previous legal framework of Directive 2006/42/EC. Of particular note to design engineers and procurement professionals is a structural difference: For the first time, significant changes are regulated directly within the text of the regulation itself, rather than being specified—as was previously the case—through subsequent interpretive documents and guidance materials. For procurement decisions in plant and mechanical engineering, this means that software-based and networked machine functions should, in the future, be assessed for compliance with the new requirements as early as the tender phase.

Digital Operating Instructions and Documentation Requirements Starting in 2027

A technician is checking a circuit diagram on a tablet; a QR code for the machine's CE marking is affixed to the control cabinet.
Digital First, Paper Upon Request: New Rules Starting in 2027

Effective January 20, 2027, the EU Machinery Regulation (EU) 2023/1230 generally permits the digital provision of operating instructions, thereby eliminating the previous requirement for them to be provided exclusively in paper form. However, safety-related information must still be provided in paper form free of charge upon the user’s request, and additional protective measures apply to non-professional users, as digital availability cannot be readily assumed in these cases. The digital manual must be easy to find, downloadable, and permanently storable; the regulation specifies that it must remain available for ten years after the machine is placed on the market. This has practical implications for control cabinet manufacturers and plant engineers: Structured document management is required, as are QR codes on the nameplate that link to the corresponding digital instructions, along with traceable versioning and archiving throughout the entire required period. Since the transition affects technical processes, web hosting, and internal responsibilities, it is advisable to adapt documentation processes early on, before the new regulations become mandatory.

Additional Information on Standards in Control Panel Construction

Several open control cabinets are standing in a factory, while employees are working at workbenches.
Correctly Classifying CE Within the Standards Framework

The CE marking on a machine does not stand alone; rather, it is part of a comprehensive regulatory system that, particularly in control cabinet construction, links several sets of regulations. With regard to electrical equipment, it is important to note that immunity and emission tests are mandatory unless components that are already CE-marked are used. For low-voltage switchgear assemblies, DIN EN IEC 61439-1 (VDE 0660-600-1) serves as the foundational standard, providing the “General Requirements”; it completely replaced the previous DIN EN 60439 as of November 2014 and is supplemented by product-specific sub-standards. Design engineers and purchasers can find the entire scope of related standards —including DIN EN 61439, DIN EN 60204-1 for the electrical equipment of machines, and DIN VDE 0100 for installation regulations for electrical systems—summarized on the parent Hub page “Control Cabinet Construction: Standards.” In summary: The CE mark is a self-declaration by the manufacturer, triggered by new construction, modification, integration, or import, and is always based on a documented risk assessment.

Additional Standards for Control Panel Construction

This page is part of our series on standards. For a comprehensive overview, see the page on Control Cabinet Construction Standards; for details on the other standards:

Do you need a control cabinet manufactured in accordance with standards? Unitechnik is your partner for control cabinet and switchgear construction —UL-certified for over 50 years.

Your contact persons

Dirk Schütz

Dirk Schütz

Head of Switchgear Construction Department

T +49 2261 987-405
E-Mail | vCard

Felix Trommershausen

Felix Trommershausen

Sales Switchgear Construction

T +49 2261 987-413
E-Mail | Linkedin | vCard

FAQ

How does linking multiple machines together to form a complete system affect CE marking?

If several individual machines and partly completed machines are connected in such a way that a functional relationship is established—for example, through a shared material flow, a common control system, and shared safety functions—this combination is considered a “group of machines” within the meaning of the Machinery Directive 2006/42/EC. A key requirement here is a system-wide emergency stop concept based on stop categories 0, 1, and 2, which must operate uniformly across all component machines.

The following are required for such a system:

  • a separate risk assessment for the entire system
  • a separate EC Declaration of Conformity
  • a separate CE marking prior to placing the system on the market

Although the existing CE markings on the individual machines remain in place, they do not replace the overarching overall assessment. The interfaces between the higher-level control system and the central control cabinet are of particular importance here, as this is where all safety-related signals from the sub-machines converge and must be coordinated.

Who is responsible when an operator makes significant modifications to an existing machine?

If an operator makes a substantial modification to an existing machine, the operator assumes all manufacturer obligations under the Machinery Directive 2006/42/EC, since the machine is legally considered to be newly manufactured. The operator thereby becomes the “modifier” as defined by the Directive and is responsible for:

  • a new risk assessment
  • a complete conformity assessment
  • preparing the technical documentation
  • Issuing a new EC Declaration of Conformity
  • affixing a new CE marking

At the same time, the operator remains responsible for ongoing risk assessments and periodic inspections in accordance with the Industrial Safety Regulation. This dual role is often overlooked in practice, yet it plays a decisive role in determining actual liability toward market surveillance authorities.

What constitutes a "significant change" to a machine within the meaning of the Machinery Directive?

A modification to an existing machine is considered a significant change if it creates an additional risk or increases an existing risk that was not taken into account in the original conformity assessment. A three-step assessment process is used to evaluate this:

  • Does a new hazard arise, or is an existing risk increased?
  • Can the increased risk be reduced back to its original level through simple protective measures?
  • Does the intended use, function, or performance of the machine change significantly?

Typical examples include a control system retrofit with a new safety control system, an increased feed rate or rotational speed, an additional handling module, the reprogramming of a robot, or an expansion of the working area. Pure maintenance, repairs, or the replacement of identical spare parts do not introduce a new hazard and are not considered a significant modification.

What role does the Machinery Directive 2006/42/EC play in CE marking?

The Machinery Directive 2006/42/EC is the key piece of legislation that defines the conformity assessment procedure for machinery and thus forms the basis for CE marking. Implemented in Germany by the 9th ProdSV, it defines the structure of the conformity assessment process: the scope of application, including the definition of “machinery”; the essential health and safety requirements set forth in Annex I; and the conformity assessment procedures outlined in Annexes VIII through X. Annex IV lists particularly hazardous machinery for which the involvement of a Notified Body is mandatory. If the manufacturer applies harmonized standards whose references are published in the Official Journal of the EU, a presumption of conformity applies with regard to the respective safety and health requirements. The Directive remains binding until it is superseded by the EU Machinery Regulation (EU) 2023/1230 on January 20, 2027.

Who is authorized to affix the CE mark to a machine?

The manufacturer of a machine is solely responsible for the CE marking, as this is not, legally speaking, a form of external certification but rather a self-declaration following a conformity assessment procedure. In this context, a “manufacturer” also includes anyone who builds a custom machine themselves, links multiple machines together to form a complete system, or makes substantial modifications to an existing machine. Other economic operators may assume the role of manufacturer, such as importers from third countries or operators in the case of substantial modifications. Pure distributors merely resell the machine without modification and do not assume any manufacturer’s obligations. The marking itself is applied by physically affixing the CE mark in a visible, legible, and permanent manner—in practice, usually on the nameplate, immediately next to the manufacturer’s information, the designation, serial or model number, and year of manufacture of the machine, with a minimum height of 5 millimeters while maintaining the specified proportions.

When is a CE marking required by law for a machine?

A CE marking is required by law as soon as a machine, as defined by the Machinery Directive 2006/42/EC, is placed on the market or put into service. This requirement applies in particular to:

  • The manufacture of a new complete machine
  • In-house construction or custom-built machines, even if used exclusively for internal operations
  • Importing a machine from a non-EEA country
  • The integration of several individual machines into a complete system
  • Significant modification of an existing machine

It is irrelevant whether the machine is transferred to a third party for a fee or free of charge. In contrast, used machines that were first placed on the market within the EEA and remain unchanged upon resale do not require a new CE marking.

What exactly does the CE marking mean for machinery?

The CE marking on a machine is not an external certification by an independent body, but rather a self-declaration by the manufacturer. It is based on a conformity assessment procedure that includes the evaluation of all relevant risks and documents compliance with all applicable EU legislation, in particular the Machinery Directive 2006/42/EC, implemented in Germany by the 9th ProdSV. Legally, the CE marking is a declaration of conformity addressed to market surveillance authorities; it is not a test sticker. It is a mandatory requirement for placing a product on the market, making it available on the market, and putting it into service within the EU and EEA internal markets, and must be distinguished from voluntary test marks such as GS or DGUV-Test.

What are the potential consequences of a missing or incorrect CE marking?

If the CE marking is missing or is incorrect, the machine is considered unfit for placement on the market; market surveillance authorities may prohibit its placement on the market, order its withdrawal from the market, or retroactively prohibit its prior distribution. Under the Product Safety Act, fines may also be imposed; in serious cases involving personal injury, the manufacturer or operator may also face criminal liability. Under civil law, the responsible party is liable to injured parties as well as under product liability provisions. The same consequences apply to operators who make a significant modification without a new conformity assessment, as they thereby assume the manufacturer’s obligations. Additionally, they risk losing insurance coverage and suffering reputational damage with customers and business partners.

What changes will take effect starting in January 2027 under the new EU Machinery Regulation (EU) 2023/1230?

Effective January 20, 2027, the EU Machinery Regulation (EU) 2023/1230 will fully replace the previous Machinery Directive 2006/42/EC. Since a regulation, unlike a directive, is directly applicable, national implementation via the 9th ProdSV will no longer be required. The date of placing on the market determines applicability: Machinery placed on the market prior to that date remains subject to the old law.

Among other things, the following changes will take effect:

  • New risk classification: Annex IV is replaced by a two-part Annex I, with expanded high-risk categories and mandatory involvement of Notified Bodies.
  • New requirements regarding cybersecurity, tamper resistance, software updates, and AI-supported machine behavior.
  • For the first time, direct regulation of “substantial changes” is included in the text of the regulation itself.
  • Digital operating instructions are permitted under certain conditions.

For design engineers and procurement professionals, this means that software-based and networked functions must be taken into account as early as the bidding phase.

What must an EC Declaration of Conformity include?

According to Annex II, Section 1A of the Machinery Directive 2006/42/EC, the EC Declaration of Conformity is the key document issued by the manufacturer of a complete machine. It must contain the following information:

  • Name and address of the manufacturer and, if applicable, the authorized representative
  • a unique identification of the machine, including the serial number
  • Reference to all applicable EU directives, in particular the Machinery Directive
  • A list of the harmonized standards and technical specifications applied
  • Information on the Notified Body involved, if it participated in the conformity assessment procedure
  • Place, date, and the legally binding signature of an authorized representative

Only complete machines receive an EC Declaration of Conformity; for incomplete machines, a Declaration of Incorporation is required instead.

When must a Notified Body be involved in the conformity assessment procedure?

Under the Machinery Directive 2006/42/EC, a Notified Body must always be involved whenever a machine is listed in Annex IV—such as presses, circular saws, injection molding machines, or certain lifting devices, and the relevant harmonized standards have not been applied, or have not been applied in full. In this case, either an EC type examination in accordance with Annex IX or a comprehensive quality assurance system in accordance with Annex X must be carried out. If, on the other hand, the harmonized standards have been fully applied, there is a choice between several procedures. For all machinery not listed in Annex IV, internal production control in accordance with Annex VIII, under the sole responsibility of the manufacturer and without external inspection, is sufficient.

What are the essential health and safety requirements set forth in Annex I of the Machinery Directive?

Annex I of the Machinery Directive 2006/42/EC sets forth the essential health and safety requirements that a machine must meet before being placed on the market. It is divided into general principles and chapters on mechanical, electrical, and ergonomic hazards, supplemented by specific requirements for individual categories of machinery, such as food-processing machinery or portable machinery. The annex itself does not contain fixed technical values; the interpretation is based on the current state of the art. The requirements are formulated as minimum protection objectives, the specific technical implementation of which is left to the manufacturer, whereby only the hazards actually present in the respective machine are relevant, and requirements that cannot be met may be disregarded.

What is a risk assessment according to EN ISO 12100, and why is it necessary?

The risk assessment in accordance with DIN EN ISO 12100 is the methodological core of every conformity assessment under the Machinery Directive 2006/42/EC and is carried out as an iterative process. It involves defining the boundaries of the machine, identifying all hazards throughout all life cycles, and subsequently assessing and evaluating the risks. This process determines the need for risk reduction, with measures implemented in a fixed order of priority: first, inherently safe design; second, technical protective measures; and finally, user information.

This process is necessary because, without this systematic hazard analysis, compliance with the essential safety requirements set forth in Annex I cannot be demonstrated; its results are a mandatory component of the technical documentation and a prerequisite for CE marking.

How does the conformity assessment procedure for a machine work?

The conformity assessment procedure follows a fixed sequence of steps: First, the manufacturer defines the intended use and any reasonably foreseeable misuse, identifies all applicable legal requirements, and conducts the risk assessment in accordance with EN ISO 12100. Based on this, suitable harmonized standards are selected, and protective measures are implemented according to the three-step approach: inherently safe design, followed by technical protective measures, and finally user information. Next, it is determined which procedure under Annexes VIII through X of the Machinery Directive applies, before technical documentation in accordance with Annex VII and the instruction manual are prepared. The process concludes with the Declaration of Conformity and CE marking. The process is iterative: if design details change, the risk assessment must be repeated.

Do machines imported from non-EU countries also require CE marking?

Yes. When importing a machine from a third country into the EEA, the importer becomes the responsible economic operator for the purposes of placing the machine on the market and must verify, prior to making it available on the EEA market, that the conformity assessment, technical documentation, and EC Declaration of Conformity are in fact available. If this documentation is missing or if the importer acts under their own name, they assume all of the manufacturer’s obligations in full, as if they had manufactured the machine themselves—including risk assessment, technical documentation, and CE marking.

In contrast, pure distributors, who merely resell the product without modification, are subject only to limited verification and due diligence obligations. In practice, this distinction often determines who is accountable to market surveillance authorities.