EU Machinery Regulation 2027: what applies to your robot cell
On 20 January 2027, Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC. If you operate a robot cell, this sounds like a topic for manufacturers and integrators. That holds true until the moment you modify your installation. From then on Article 18 applies, and the manufacturer's obligations pass to you.
Reading time approx. 11 minutes
What changes on 20 January 2027
Regulation (EU) 2023/1230 applies from 20 January 2027 and replaces the Machinery Directive 2006/42/EC in full. For placing machinery on the market under the old rules, the option ends on exactly that day. The regulation provides no transition period beyond it.
The most important formal difference sits in the name. A directive had to be transposed into national law by each member state, which produced differences between countries. A regulation applies directly in every member state. Germany, for example, supplements it with a national enforcement act, but that act does not replace the regulation itself.
Some articles already apply. The provisions on conformity assessment bodies in Articles 26 to 42 have applied since 20 January 2024, so that notified bodies are accredited in time. Article 50(1) on market surveillance applies from 20 October 2026. For day-to-day manufacturing, 20 January 2027 remains the date that matters.
A cell that was lawfully placed on the market or put into service before that date keeps its status. Legacy status covers the condition in which the installation was assessed. Once that condition changes, the legal position changes with it.
Why the regulation does not address you as an operator
The Machinery Regulation addresses economic operators who bring a product to market: manufacturers, authorised representatives, importers and distributors. It defines no separate role for the party who simply runs the machine.
The key concept here is placing on the market, meaning the first making available of a machine on the Union market. As long as you only operate a cell, you place nothing on the market.
Your duties as an employer and operator sit in different legislation. Across the EU they follow from the Use of Work Equipment Directive 2009/104/EC and its national implementations, covering risk assessment at the workplace, safe provision of work equipment, periodic inspection and staff instruction. Both frameworks run in parallel, and that is exactly what causes confusion.
The Machinery Regulation governs the conditions under which a machine may be placed on the market. Workplace legislation governs how you operate it afterwards. Only when you intervene in the installation yourself do you move from the second world into the first.
In the normal case this means that whoever orders a turnkey cell receives it with CE marking and a declaration of conformity for the complete installation. Who carries that responsibility belongs in writing before the order. Which points to record is covered in the article on choosing a system integrator for your robot cell.
Article 18: when you become the manufacturer
Article 18 of the regulation governs substantial modification. Anyone who carries out such a modification is considered a manufacturer for the purposes of the regulation and takes on the obligations set out in Article 10.
The regulation defines substantial modification through three elements. It is a physical or digital change to a machine that the manufacturer neither foresaw nor planned. It happens after the machine was placed on the market or put into service. And it affects safety, either by creating a new hazard or by increasing an existing risk.
All three elements have to come together. If one is missing, there is no substantial modification:
- Not foreseen by the manufacturer: if the manufacturer describes a modification in the instructions and defines its limits, no substantial modification arises. What sits in the documentation therefore carries direct commercial value.
- Physical or digital: earlier debates centred on mechanics. The regulation now states explicitly that a software change can constitute a substantial modification.
- New hazard or increased risk: the only yardstick is whether the safety level deteriorates. Changes without a safety dimension stay outside the definition.
The consequence goes beyond paperwork. Whoever counts as the manufacturer takes on five obligations before the modified product is placed on the market or put into service:
- carry out a new risk assessment
- compile the technical documentation
- complete the conformity assessment procedure
- sign the EU declaration of conformity
- affix the CE marking
The regulation names one explicit exception. A non-professional user who modifies their own machine for personal use does not count as a manufacturer. In an industrial setting that exception does not apply.
What this means for typical modifications to robot cells
Robot cells rarely run unchanged for years. New products, new batch sizes, a different gripper: modification is the normal case, and each one meets the same three-part test from Article 18. With every intervention, the decisive question is whether a new hazard arises or an existing risk increases.
The risk assessment answers that question, not intuition. The table below shows what the assessment examines for seven typical interventions. It replaces no case-by-case review.
| Intervention in the cell | What the assessment examines |
|---|---|
| Fitting a heavier gripper | Do payload and centre of gravity change, and with them overtravel and stopping distance? Does the safety distance still hold? |
| New workpiece, same gripper | Do new hazards arise from the shape, edges, weight or temperature of the part? |
| Raising cycle rate or speed | Higher speed changes stopping distances and, in collaborative operation, force and pressure values |
| Updating safety-related software | A digital change within the meaning of Article 18. Check whether the manufacturer foresaw the update |
| Moving or removing a safeguard | A direct intervention in the safety concept, in practice almost always subject to assessment |
| Linking a second cell to the existing one | An assembly of machinery arises, with its own analysis of the interfaces |
| Relocating the robot to another site | Usually uncritical without changes to function and safety equipment, though surroundings and linking need fresh review |
The practical leverage sits before the modification. Anyone who establishes at procurement stage which changes the manufacturer covers in the documentation moves later modifications outside the definition of substantial modification. How to define the scope of a project cleanly is covered in the article on the cost of a turnkey robot solution.
Software, cybersecurity and documentation
The largest substantive changes concern areas that barely mattered in 2006: software, connected installations and the form of the instructions.
Software with a safety function: the regulation treats software that performs a safety function as a safety-related component. On a reasoned request from a competent national authority, the source code or programming logic of that software has to be provided. For you as an operator, what matters most is who holds those records if it comes to that.
Cybersecurity: for the first time, the regulation addresses tampering with machinery through industrial communication systems. A cell whose safety function can be disabled over the network does not meet the requirements. Remote maintenance access, controller updates and network segmentation all fall within scope.
Digital instructions: instructions for use may be supplied in digital form. They have to be printable, downloadable and storable, and must stay available online for the expected lifetime of the machine, and for at least ten years after it was placed on the market. On request, a paper version has to be supplied free of charge within one month. These requirements sit in Annex III.
Higher risk, stricter procedure: Annex I lists machinery categories carrying particular risk. For the categories in Part A, a notified body has to be involved, for instance through EU type-examination. New to this list are safety components with fully or partially self-evolving behaviour based on machine learning. Conventional robot cells generally fall outside it, AI-driven safety functions do not.
ISO 10218 in its 2025 edition
Alongside the regulation, the central robotics standard has been revised. Since the 2025 edition, ISO 10218 no longer separates industrial robots from collaborative robots.
Part 1 introduces two risk classes instead, each with its own requirements for safety, control and integration. The assessment covers the application, not the product category. A cobot moving a sharp-edged sheet at speed is not a harmless application merely because the nameplate says collaborative.
The standard has two parts with different audiences. ISO 10218-1 addresses the robot manufacturer, ISO 10218-2 the party integrating the cell. In supplier conversations, the useful question is therefore not whether someone handles cobots. It is more revealing to ask which edition they base their risk assessment on.
What applies in Great Britain and Northern Ireland
Regulation (EU) 2023/1230 applies in the European Union. For the British market the position differs, and it differs by nation.
Great Britain, meaning England, Scotland and Wales, continues to run its own regime under the Supply of Machinery (Safety) Regulations. The United Kingdom recognises CE marking for machinery indefinitely, a decision announced in August 2023 and set in law in October 2024. Manufacturers placing machinery on the GB market can therefore use either CE or UKCA marking. An amending instrument covering the supply of machinery was made in 2026 and applies from 20 January 2027, the same day as the EU regulation.
Northern Ireland follows EU product rules, so Regulation (EU) 2023/1230 applies there directly.
For anyone supplying machinery into the European Union, the practical answer stays simple. Whoever places a cell on the EU market meets the EU requirements, regardless of where the company is based.
What to settle before January 2027
Existing installations carry no retrofit obligation. Six points can be worked through now, because action is required for anything newly placed on the market from the cut-off date of 20 January 2027, and for every modification after it:
- Take stock of installations: record which cells you run, who signed the declaration of conformity for each, and where the technical documentation sits.
- Make documentation accessible: any modification requires the manufacturer's records. Missing documentation is the most common reason a simple modification turns into a project.
- Schedule planned modifications: if an extension is coming anyway, timing makes a difference. The old rules apply before the cut-off date, the new ones after it.
- Adjust procurement: new enquiries should state which legal framework the delivery follows and which changes the documentation covers.
- Settle software responsibility: define who may update safety-related software and how conformity is documented when they do.
- Name an owner: one person in the company should be able to judge when a change crosses the threshold into substantial modification.
Working through these points before the next enquiry produces a sharper conversation with suppliers. How a cell runs from planning through to acceptance is described in the article on commissioning turnkey robot solutions.
Frequently asked questions
When exactly does the EU Machinery Regulation apply?
Regulation (EU) 2023/1230 applies from 20 January 2027. Some articles apply earlier, including the provisions on conformity assessment bodies since 20 January 2024 and the market surveillance rule in Article 50(1) from 20 October 2026. The date governs placing machinery on the market, not the operation of machinery already in service. A cell running on your shop floor on 19 January 2027 may keep running on 20 January without any change.
Do I have to retrofit my existing robot cell?
No retrofit obligation applies. An installation lawfully placed on the market or put into service before the cut-off date keeps its status in the condition in which it was assessed. Its operation continues to follow workplace legislation. The exception is your own intervention: once you modify the cell substantially, Article 18 applies and the assessment starts again under the new rules.
When do I become the manufacturer as an operator?
You become the manufacturer as soon as you carry out a substantial modification within the meaning of Article 18. That means a physical or digital change the manufacturer did not foresee, through which a new hazard arises or an existing risk increases. The manufacturer's obligations in Article 10 then apply to you.
Is fitting a different gripper a substantial modification?
A gripper change resists a blanket answer. What matters is whether it creates a new hazard or increases a risk, for instance through altered payload, a shifted centre of gravity or longer stopping distances. Where the manufacturer foresaw the change in the documentation and defined its limits, no substantial modification generally arises.
Does a software update count as a substantial modification?
A software update can amount to a substantial modification. The regulation names digital changes explicitly. What decides is whether the change is safety-related and whether the manufacturer foresaw it. A controller update released and documented by the manufacturer stays within the foreseen scope. Reprogramming a safety function yourself, or raising a speed limit set in the safety controller, does not.
What changes for the instructions for use?
Instructions may be supplied digitally, but have to be printable, downloadable and storable. They must stay available online for at least ten years after the machine was placed on the market. On request, a paper version has to be supplied free of charge within one month.
Does my cell need a notified body?
Most robot cells require no notified body. Their involvement covers the categories in Annex I Part A, including safety components with self-evolving behaviour based on machine learning. Conventional robot applications usually fall outside that list. Whoever performs the conformity assessment establishes the category, which is one more reason to settle that role in the contract before the order.
Does the regulation apply to machinery supplied to the United Kingdom?
Great Britain runs its own regime under the Supply of Machinery (Safety) Regulations and recognises CE marking for machinery indefinitely. Northern Ireland follows EU product rules, so Regulation (EU) 2023/1230 applies there directly. Anyone placing machinery on the EU market meets the EU requirements regardless of company location.
Who is liable if the CE marking for the complete installation is missing?
Responsibility sits with whoever places the complete installation on the market or puts it into service. In a turnkey project that is the system integrator. Where several trades are contracted separately, it passes to the operator. Which points belong in the contract is covered in the article on selecting an end effector.
Sources
- Regulation (EU) 2023/1230 on machinery, Official Journal of the European Union, in particular Article 10, Article 18, Article 54, Annex I and Annex III
- ISO 10218-1:2025 and ISO 10218-2:2025, Robotics, Safety requirements, International Organization for Standardization
- Directive 2009/104/EC on the use of work equipment by workers at work, Official Journal of the European Union
- Placing UKCA or CE marked products on the market in Great Britain, GOV.UK guidance
