EU Machinery Directive Starting in 2027: What Applies to Your Robotic Cell

On January 20, 2027, Regulation (EU) 2023/1230 will replace the Machinery Directive 2006/42/EC. As the operator of a robotic cell, this may sound like an issue for manufacturers and integrators. That’s true—until you make a significant change to your system. At that point, Article 18 applies, and the manufacturer’s obligations for the affected machine or part of the system are transferred to you.

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Table of Contents

- What Will Change on January 20, 2027
- Why the regulation does not initially apply to you as an operator
- Article 18: When You Become a Manufacturer Yourself
- What this means for typical modifications to robot cells
- Software, cybersecurity, and documentation
- ISO 10218, 2025 edition
- What needs to be clarified by January 2027
- Frequently Asked Questions

What Will Change on January 20, 2027

Regulation (EU) 2023/1230 takes effect on January 20, 2027, and replaces the Machinery Directive 2006/42/EC. As of that date, machinery may no longer be placed on the market for the first time in accordance with the old directive. However, products that were already lawfully placed on the market prior to this date may continue to be made available on the market. EC type-examination certificates issued under the Machinery Directive that are still valid will remain valid until their expiration.

The most important formal difference lies in the name. Each Member State had to transpose a directive into national law, which led to variations between countries. A regulation is directly applicable in all Member States. In Germany, the Machinery Regulation Implementation Act (MaschinenDG) supports its application but does not replace the regulation.

Certain articles take effect earlier. The provisions regarding conformity assessment bodies in Articles 26 through 42 have been in effect since January 20, 2024, to ensure that notified bodies are accredited in a timely manner. Article 50(1), concerning the penalties to be determined by the Member States, takes effect on October 20, 2026. For manufacturing practices, the effective date remains January 20, 2027.

A cell that was lawfully placed on the market or put into service before this date does not need to be re-CE-marked or retrofitted across the board solely because of the new Machinery Regulation. However, this does not constitute unrestricted grandfathering: According to the Industrial Safety Regulation, you must regularly review the risk assessment and protective measures, taking into account the state of the art and adapting them as necessary. As soon as the system is modified, you must also determine whether a substantial change has occurred.

Why the regulation does not initially apply to you as an operator

The Machinery Regulation is directed at economic operators such as manufacturers, authorized representatives, importers, and distributors. It also covers manufacturers who produce and put a machine into service for their own use. It does not recognize a separate role of “operator” with its own obligations.

The key term here is “placing on the market.” This refers to the first-time provision of a machine on the EU market. As long as you exclusively operate a cell that has been made available in compliance with the law, you are not placing anything on the market and therefore do not become a manufacturer.

Your obligations as an employer and plant operator are set forth in other regulations. In Germany, these stem from the Industrial Safety Regulation (BetrSichV) and the Occupational Safety and Health Act: risk assessment, safe provision and use of work equipment, training of employees, and inspections, to the extent required by the risk assessment and the provisions of the BetrSichV. Both sets of regulations operate in parallel, and this is precisely what regularly leads to confusion.

The Machinery Ordinance governs the conditions under which a machine may be placed on the market or put into service for the first time. The Industrial Safety Ordinance governs how you must use it thereafter. If you make modifications to the system yourself, the Industrial Safety Regulation always remains relevant. You only assume the role of a manufacturer under the Machinery Regulation if the modification meets the criteria for a substantial change or if you yourself manufacture a new machine or a set of machines for your own use.

Normally, this means that anyone commissioning a turnkey cell should receive it with a CE marking (Conformité Européenne) and an EU Declaration of Conformity for the entire system. However, who bears responsibility for conformity depends on the actual project structure and division of roles and must be clarified before placing the order. The points that need to be documented in writing are outlined in the article on selecting a supplier for robot cells.

Article 18: When You Become the Manufacturer Yourself

Article 18 of the Regulation governs substantial modifications. Anyone who makes such a modification is considered a manufacturer for the purposes of the Regulation and is subject to the obligations set forth in Article 10.

The Regulation defines a substantial change as consisting of four elements. It is a physical or digital change to a machine that the manufacturer neither intended nor planned. It occurs after the machine has been placed on the market or put into service. It compromises safety by creating a new hazard or increasing an existing risk. And it either requires additional protective devices—the installation of which necessitates a modification to the existing safety control system—or additional protective measures to ensure stability or mechanical strength.

All four components must be present. If one is missing, there is no substantial modification within the meaning of the Machinery Regulation:

- Not intended by the manufacturer: If the manufacturer describes a modification in the operating instructions, defines its limits, and the modification is carried out within those limits, this argues against it being a substantial modification. What is stated in the documentation is therefore directly worth its weight in gold.
- Physical or digital: Previous discussions often centered on mechanical aspects. The regulation now explicitly clarifies that a software modification can also constitute a substantial change.
- New hazard or increased risk: It must be determined whether a new hazard arises or an existing risk increases. Changes unrelated to safety are not considered.
- Additional qualified protective measures: In addition, either new protective devices must be required—which necessitate an intervention in the existing safety control system—or additional measures must be taken to ensure stability or mechanical strength.

This is not a mere formality. Anyone considered a manufacturer assumes the obligations under Article 10 that apply to the machine in question. These include, in particular:

- complying with the essential health and safety requirements and conducting a risk assessment
- preparing and retaining the technical documentation
- undergoing the appropriate conformity assessment procedure
- issuing the EU Declaration of Conformity
- affixing the CE marking and the required identification information
- provide the required instructions and information
- Fulfill corrective, informational, and cooperative obligations when risks are identified

In the case of a set of machines, this responsibility may be limited to the machine affected by the modification if the risk assessment shows that the modification has no impact on the safety of the rest of the set.

The regulation explicitly states one exception: A non-professional user who modifies their own machine for personal use is not considered a manufacturer. This exception does not apply in an industrial setting.

What this means for typical modifications to robot cells

Robot cells rarely operate unchanged for years. New products, new batch sizes, a different gripper: change is the norm. Whenever a modification is made, the first question is whether a new hazard arises or an existing risk increases. Furthermore, for a modification to be considered a “substantial change” under the Machinery Regulation, the complete four-point test specified in Article 3(16) must be met.

The answer is provided by the risk assessment, not by gut feeling. The following overview shows what the assessment examines for seven typical cases. It does not replace a case-by-case review.

The practical solution lies in the planning phase before the conversion. By specifying during the procurement phase which modifications the manufacturer will cover in the documentation, you can prevent a later conversion from being classified as a change not intended by the manufacturer. This requires that the documented limits be adhered to. The article on the costs of a turnkey robot solution demonstrates how to clearly define the scope of work for a project .

Software, Cybersecurity, and Documentation

The most significant changes in terms of content concern areas that played hardly any role in 2006: software, networked systems, and the format of the operating instructions.

Software with a safety function: Software placed on the market independently may be considered a safety-related component if it performs a safety function and meets the other requirements of the Regulation. Upon a justified request from a competent national authority, the source code or programming logic of safety-related software must be provided, to the extent necessary to verify conformity with Annex III. In principle, the manufacturer must retain this information. For you as an operator, therefore, the most important consideration is who can provide these documents in the event of an emergency.

Cybersecurity: For the first time, the regulation explicitly addresses the protection of safety-related machine functions against unintentional or intentional tampering. A cell whose safety function can be bypassed via the network does not meet the requirements. This applies to remote maintenance access, control updates, and network disconnection.

Digital Operating Instructions: The operating instructions may be provided digitally. They must be printable, downloadable, and savable. They must remain available online for the machine’s expected service life, but for at least ten years after it is placed on the market. If the user requests a paper copy at the time of purchase, it must be provided free of charge within one month. For machinery intended for non-professional users or that can reasonably be used by them, the safety information essential for safe commissioning and use must also be supplied in paper form. These requirements are set forth primarily in Article 10(7); Annex III governs the content and drafting of the instructions.

Higher Risk, Stricter Procedure: Annex I lists categories of machinery posing a particular risk. For the categories in Part A, a conformity assessment procedure involving a notified body is required. New additions to this list include safety components with fully or partially self-learning behavior based on machine learning that ensure safety functions. Also included are machines with embedded systems of this type that were not placed on the market independently—though only with respect to these systems. Traditional robotic cells are generally not covered. Not every AI-supported safety function automatically falls under Part A; the specified characteristics are decisive.

ISO 10218, 2025 edition

In parallel with the regulation, the core robotics standard has been revised. Since the 2025 revision, ISO 10218 no longer treats the “cobot” as a separate safety-related product category. Only a specific robot application can be designed, verified, and validated as collaborative.

Part 1 introduces two robot classes. Classification into Class I or Class II is based on the mass per manipulator, the maximum force, and the maximum speed, and is associated with different functional safety requirements. The risk assessment of the specific application is conducted separately from this. A robot that moves a sharp-edged sheet of metal at high speed is not a harmless application simply because it is colloquially referred to as a “cobot.”

The standard consists of two parts aimed at different audiences. ISO 10218-1 is intended for robot manufacturers, while ISO 10218-2 is intended for those who integrate the application or cell. Therefore, when discussing matters with suppliers, it is not useful to ask whether someone is proficient with cobots. It is more informative to ask which version they are using to conduct the risk assessment.

Standards are generally voluntary. A legal presumption of conformity arises only if a harmonized EN standard for the relevant legislation has been published in the Official Journal of the European Union. As of the publication date of this article, the official list for the Machinery Directive still listed EN ISO 10218-1:2011 and EN ISO 10218-2:2011, not the 2025 editions. The new editions may influence the state of the art but do not, on their own, establish an automatic presumption of conformity.

What needs to be clarified by January 2027

For existing installations, there is no blanket requirement to retrofit solely due to the new Machinery Regulation. The obligations under the Industrial Safety Regulation, including the review and necessary adjustment of protective measures, remain in effect. Additional requirements under product safety law apply to anything newly placed on the market or put into service for the first time as of the effective date, as well as to any substantial modifications made thereafter. There are six steps to take now:

- Take inventory of equipment: Identify which cells are in your inventory, who signed the declaration of conformity for each one, and where the operating instructions, declaration of conformity, and existing change documentation are located.
- Make documentation accessible: When performing a modification, you’ll need all available information from the manufacturer that’s necessary for a safe assessment and implementation. As a general rule, the manufacturer must retain the complete technical documentation for the authorities and does not automatically transfer it to the operator. If a modification makes you the manufacturer yourself, you must create your own technical documentation. Therefore, the necessary access to documents should be clarified contractually at an early stage.
- Schedule planned modifications: If an expansion is already planned, the timing makes a difference in terms of which product safety regulations apply. Before the effective date, the previous regulations apply; after that, the new regulation takes effect. However, even under the previous regulations, a significant change can trigger a new conformity assessment.
- Adjust procurement: In new requests for quotes, specify which version of the law applies to the delivery and what changes the documentation covers.
- Clarify software versions: Determine who is authorized to update safety-critical software and how compliance is documented during the process.
- Assign responsibility: One person in the company should be able to assess when a change reaches the threshold for a significant change.

Those who clarify these points before the next request will be able to have more precise discussions with suppliers. The article on the commissioning of turnkey robot solutions describes how a cell operates from planning through acceptance .

Frequently Asked Questions

When exactly does the EU Machinery Directive take effect?

Regulation (EU) 2023/1230 generally takes effect on January 20, 2027. Certain articles take effect earlier, including the provisions on conformity assessment bodies, which have been in effect since January 20, 2024, and Article 50(1) on penalties to be determined by Member States, which takes effect on October 20, 2026.

Do I need to retrofit my existing robotic cell?

The entry into force of the new Machinery Regulation alone does not automatically require a new CE marking or impose a blanket retrofitting obligation for a system that was previously placed on the market or put into service in compliance with the law. Operation continues to be governed by the Industrial Safety Regulation. According to this regulation, you must regularly review the risk assessment and protective measures, taking into account the state of the art, and adapt them as necessary. In individual cases, this may result in specific retrofitting.

When do I, as an operator, become a manufacturer?

You become a manufacturer if you make a substantial change as defined in Article 3(16) and Article 18. This refers to a physical or digital modification not intended by the manufacturer after the equipment has been placed on the market or put into service, which creates a new hazard or increases an existing risk and, in addition, requires either new protective devices that interfere with the existing safety control system or further measures to ensure stability or mechanical strength. In such cases, the manufacturer’s obligations under Article 10 apply to the affected machine or, where applicable, to the affected part of an assembly.

Is changing the gripper a substantial modification?

A gripper change cannot be classified across the board. The decisive factor is whether the complete statutory test is met: for example, whether a risk is increased due to a changed load capacity, a shifted center of gravity, or longer stopping distances, thereby requiring additional qualified protective measures. If the manufacturer has provided for the change in the documentation, defined its limits, and these limits are adhered to, this indicates that it is not a substantial modification.

Does a software update count as a significant modification?

A software update can constitute a significant modification. The regulation explicitly mentions digital modifications. The decisive factors are whether the manufacturer has provided for the change and whether all other criteria of the legal definition are met. Regardless of this, the employer must assess the safety-related implications of an update in accordance with the Industrial Safety Regulation.

What changes apply to the operating instructions?

The operating instructions may be provided digitally, but must be printable, downloadable, and savable. They must remain available online for the expected service life of the machine, but for at least ten years after it is placed on the market. If the user requests a paper copy at the time of purchase, it must be provided free of charge within one month. For machines intended for non-professional users or that are foreseeable to be used by them, essential safety information must also be provided on paper.

Do I need a notified body for my cell?

A notified body is not required for most robot cells. Its involvement is mandatory in the conformity assessment procedures for the categories listed in Annex I, Part A. These include certain safety components with fully or partially self-learning behavior based on machine learning, as well as corresponding embedded systems—in the case of the latter, only with respect to these systems. Traditional robot applications are generally not covered solely because of the robot used.

Who bears responsibility for conformity if the CE marking is missing for the entire system?

The party responsible under conformity assessment regulations is the one who actually manufactures the robotic cell or a set of machines—or has them manufactured—and places them on the market under their own name or manufactures them for their own use. Whether this is a system integrator, general contractor, or operator depends on the actual project structure and division of roles. Whether the project is awarded on a turnkey or split basis does not automatically determine this. The roles should therefore be clearly documented in a contract before the project begins. Civil liability, as well as regulatory or criminal liability, must be assessed separately. The article on selecting the end-effector outlines which points should be included in the contract .

Sources

- Regulation (EU) 2023/1230 on Machinery, in particular Article 3(16), Article 10, Article 18, Article 25, Article 50, Article 52, and Article 54, as well as Annex I and Annex III
- Corrigendum to Regulation (EU) 2023/1230
- ISO 10218-1:2025 and ISO 10218-2:2025, Robotics — Safety requirements, International Organization for Standardization
- Industrial Safety Regulation (BetrSichV), in particular Sections 3, 4, 10, and 14
- Occupational Safety and Health Act (ArbSchG)
- Machinery Ordinance Implementation Act (MaschinenDG), in particular Section 11
- BMAS Interpretation Paper “Substantial Modification of Machinery” for the law in effect until January 19, 2027
- BMAS Interpretation Paper “Assembly of Machinery”
- European Commission: Harmonized Standards for the Machinery Directive