What the Machinery Regulation is and when it applies
The Machinery Regulation (EU) 2023/1230 sets the safety requirements that a machine must meet when it is placed on the market or put into service in the EU. As a regulation rather than a directive, it applies identically in every Member State.
The date of application is 20 January 2027, as reported by the European Agency for Safety and Health at Work (EU-OSHA). The original text stated 14 January; the date was corrected by a corrigendum published in July 2023. Some parts already apply earlier, for example the rules on notified bodies.
For robots already in circulation, article 52 matters: Member States may not prevent the making available of products placed on the market in conformity with Directive 2006/42/EC before the application of the regulation. A G1 or a Go2 sold today with documentation conforming to the directive does not need to be "made compliant again" in 2027.
Who is the manufacturer and who signs the declaration
The EU declaration of conformity and the CE marking are the responsibility of the manufacturer (art. 10). The regulation, however, identifies other parties who can take on that role:
- Importer (art. 13): before placing the robot on the market, verifies that the manufacturer has carried out the conformity assessment, drawn up the technical documentation and affixed the CE marking.
- Distributor (art. 15): must exercise due diligence as regards conformity.
- An importer or distributor who sells under their own name or trademark, or who modifies the product in a way that affects conformity, becomes the manufacturer (art. 17).
- Anyone who makes a substantial modification becomes the manufacturer for that machine (art. 18).
Even those who assemble several machines that work together for the same result create an "assembly of machinery" (art. 3), which in turn is a machine with its own manufacturer. This is the typical case of a robot integrated into a cell with conveyors, guards and a safety PLC.
When a modification is substantial
The definition in article 3, point 16, is precise. A modification is substantial when, by physical or digital means, after being placed on the market:
- it is not foreseen or planned by the manufacturer;
- it affects safety by creating a new hazard or increasing an existing risk;
- it requires new guards or protective devices involving a modification of the safety control system, or new measures for stability or mechanical strength.
For a Unitree robot, the cases to assess carefully are:
- a locomotion controller written or trained by you in place of the factory one;
- an end effector or a load that changes the centre of gravity and stability;
- use in an area shared with people that the manufacturer had not foreseen.
Repair and maintenance that do not affect conformity are not substantial modifications (recital 26 of the regulation). A non-professional user who modifies their own machine for their own use does not become the manufacturer. A company or a laboratory, however, are professional users.
What changes compared with Directive 2006/42/EC
Software and digital components
The regulation defines a "safety component" also as a digital component, including software, placed on the market separately (art. 3, point 3). Software modifications expressly fall among those that may be substantial.
Protection against tampering (Annex III, point 1.1.9)
- The connection of another device, even remote, must not create hazardous situations.
- Safety-critical software and data must be identified and protected against accidental or intentional alteration.
- The machine must be able to indicate the installed safety software and keep evidence of interventions, whether legitimate or not.
Control systems (Annex III, point 1.2.1)
Control systems must also withstand reasonably foreseeable deliberate attempts by third parties. Versions of safety software loaded after placing on the market must be traceable for five years. For systems with self-evolving behaviour:
- they must not perform actions beyond the defined task and movement space;
- they must record data on safety decisions, to be kept for one year;
- they must be able to be corrected at any time.
Autonomous mobile machinery (Annex III, part 3)
A quadruped that patrols an area autonomously (for example an AS2 or an A2 on inspection) may fall within the definition of autonomous mobile machinery. Two options are foreseen, single or combined according to the risk assessment:
- work in an area enclosed by a perimeter guard;
- have devices that detect people and obstacles nearby.
Where needed, a remote supervision function must be foreseen, limited to stopping, starting and putting into a safe position.
Digital instructions (art. 10, par. 7)
Instructions may be provided in digital format, downloadable and accessible for at least 10 years. On request at the time of purchase, the manufacturer provides them free of charge in paper format within one month.
Notified body
The categories in Annex I, part A, require a procedure involving a notified body (art. 25, par. 2). These include machines integrating systems with fully or partially self-evolving behaviour, based on machine learning, that ensure safety functions, limited to those systems. A controller that has been trained and then frozen is not automatically a self-evolving system: the classification must be made on the concrete case.
AI Act and Cyber Resilience Act
- AI Act (Regulation (EU) 2024/1689). An AI system acting as a safety component of a machine may be high-risk (art. 6, par. 1). The Regulation (EU) 2026/1744 (Digital Omnibus on AI), published in the Official Journal of the EU on 24 July 2026, moved the Machinery Regulation into section B of Annex I of the AI Act. In practice, the AI Act requirements for AI integrated into machinery will be brought into the Machinery Regulation through delegated acts, which the Commission must adopt by 2 August 2028 (Cuatrecasas summary). The delegated acts have not yet been issued: the framework should be re-checked at the time of purchase.
- Cyber Resilience Act (Regulation (EU) 2024/2847). It concerns products with connected digital elements. According to the European Commission, the reporting obligations apply from 11 September 2026 and the main ones from 11 December 2027.
Reference technical standards
- ISO 12100: general principles for risk assessment and risk reduction.
- ISO 10218-1 and ISO 10218-2 (2025 edition): safety of industrial robots and their applications.
- ISO/TS 15066: human-robot collaboration.
- ISO 13482: personal care robots.
- IEC 62443: cybersecurity of industrial automation systems.
For humanoids and quadrupeds, a dedicated standard is still missing. ISO 25785-1, on industrial mobile robots with actively controlled stability (with legs, wheels or other forms of locomotion), is under development.
Checklist: before putting a Unitree robot on the shop floor
- Documents for the exact model. Ask for the EU declaration of conformity, instructions in English and the reference firmware version. Check that the model and variant match the robot delivered.
- Intended use. Compare the application you have in mind with the intended use in the instructions. If you go beyond it, you are in the field of substantial modification.
- Risk assessment according to ISO 12100. You must cover:
- falling of the robot and loss of balance;
- collisions with people;
- loads in hand or on the back;
- batteries and charging;
- behaviour in the event of loss of communication.
- Working area. Decide whether the robot works in a segregated or shared zone. In a shared zone you need people detection and verified speed limits, not just declared ones.
- Stop. Check where the emergency stop and the remote control are, how they work, and who holds them during work.
- Software. Keep a log of installed versions and updates. Any controller written by you must be assessed before use near people.
- Network and cybersecurity. On a plant network, apply three measures:
- put the robot on a separate VLAN;
- change the default credentials;
- disable remote services you do not use and decide who can update the firmware.
- Assembly of machinery. If the robot enters a cell with other machines, establish in writing who is the manufacturer of the assembly and who signs the declaration.
- Training. Train the people who work near the robot, not only those who program it.
If you are setting up a pilot project, our method for humanoid PoCs includes these steps before use on the shop floor. For inspection quadrupeds, find the application details in the guide to the quadruped for industrial inspection.
Universities and laboratories
Article 2, paragraph 2, letter m), excludes from the regulation machinery "specifically designed and constructed for research purposes and temporarily used in laboratories". A commercial robot bought from a catalogue does not automatically fall within this exclusion, because it was born as a product for sale. For a laboratory, the most prudent path remains to treat it as a machine: risk assessment, a dedicated area and a software log. More details for research groups on the Universities and research page.