Assess and collaborative machinery through the Machinery Regulation's essential health and safety requirements (EHSRs). Determine whether the product can move or work without permanent operator interaction, how people and obstacles are detected or kept outside the danger zone, whether software or digital components perform safety functions, whether cybersecurity can affect safety, and whether the machinery falls into an Annex I category that changes the conformity assessment route.
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Section 1
Autonomous mobile machinery scope
The Regulation defines as mobile machinery with an autonomous mode where all essential safety functions for travel and work are ensured without permanent operator interaction. It also defines a supervisor and a supervisory function for remote, non-permanent surveillance that can receive information or alerts and give limited orders.
For an autonomous mobile platform, the compliance record should therefore describe the intended travel area, working area, danger zones, supervised and unsupervised states, remote start or stop commands, safe-position or safe-state commands, and the limits of any remote supervisory function.
Identify whether the machinery has an autonomous mode, a remote control mode, or both.
Show that autonomous travel and work operations keep safety functions active without relying on permanent operator interaction.
Document how the supervisor can see the movement and working area directly or indirectly before remote start, stop, or safe-state actions are allowed.
Where the supervisory function is relevant, verify that the machine cannot operate while that function is inactive and that the information sent to the supervisor provides a complete and accurate view of operation, movement, and safe positioning.
Include the intended travel, working areas, and danger zones in the instructions for use.
Defines autonomous mobile machinery, supervisor, supervisory function, conditions for remote supervisory actions and operation, and instructions for autonomous travel, working areas, and danger zones.
without permanent interaction of an operator
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Section 2
Human-machine interaction and collaborative operation
For collaborative robots and shared-workspace machinery, Annex III section 1.3.7 requires protection against hazardous contact and adaptation to human-machine coexistence and interaction, including the psychological stress interaction can cause. Assess impact, crushing, collision, visibility, unexpected movement, maintenance access, and entry into a danger zone for the actual application.
For collaborative or shared-workspace operation, the risk assessment should state when a person may be near the machine, whether contact is foreseeable, what protective measures are built into the design, what warning or signalling devices are used, and how residual risks are communicated in instructions and markings.
Map people near the machine as operators, drivers, supervisors, transported persons, maintenance personnel, or exposed persons.
Assess impact, crushing, collision, trapping, rollover, unexpected movement, and access to moving parts where they are relevant to the design.
Use detection, guards, protective devices, warning devices, signs, safe stopping, speed or movement limits, and instructions only where they match the identified risk.
For remote-controlled machinery that exposes persons to impact or crushing, document movement signalling or other protective means.
Source for machinery risk assessment, risk reduction, documentation, and verification concepts used to structure the evidence pack.
risk assessment and risk reduction
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Section 3
Controls, software, and cybersecurity evidence
The Regulation treats safety software as a machinery issue when software performs a safety function or when software updates and evolving behaviour can affect risk. It also includes EHSRs for protection against corruption and safety and reliability of control systems.
For autonomous or collaborative machinery, the technical file should connect safety functions to the implemented control architecture, software version, update assumptions, validation records, cybersecurity controls that protect safety, and test evidence for failures or foreseeable misuse. Where a competent authority has a reasoned need to check EHSR compliance, the Regulation can require source code or programming logic for safety-related software.
ISO 12100, ISO/TR 22100-4 and control-system standards are technical support, not legislation. A harmonised standard creates a presumption of conformity only for the Annex III requirements covered by the cited standard or parts when its reference is published in the Official Journal. The manufacturer remains responsible for uncovered hazards and for showing that the chosen edition and clauses fit the actual machinery.
List every safety-related control function, including detection, stopping, steering, safe-state, remote-supervision limits, obstacle response, and charging-station movement where relevant.
Record the installed safety-related software version, update policy, and foreseeable future software developments considered in the risk assessment.
Keep cybersecurity evidence where corruption, malicious interference, or remote connectivity could affect a safety function.
For automatic charging, assess contact and collision hazards while the machine moves autonomously to the charging station, as required by Annex III.
Cross-reference safety-related control-system standards used, such as ISO 13849 family entries where they are applicable to the design.
Lists safety-related parts of control systems standards, including ISO 13849 entries relevant to control-system design and validation evidence.
Safety-related parts of control systems
Recommended next step
Build the autonomous machinery evidence pack
Map autonomous travel, human proximity, safety functions, software, cybersecurity, EHSRs, and conformity route evidence before release or procurement review.
The technical documentation must make it possible to assess conformity with the relevant EHSRs and include an adequate analysis and assessment of risks. For autonomous mobile or collaborative machinery, that means the file cannot stop at a generic CE checklist; it needs the hazard analysis, design rationale, standards or technical specifications, tests, calculations, control-system evidence, software evidence, instructions, markings, and residual-risk information tied to the actual machine configuration.
Instructions should be specific enough for the way the machine is used. For , the Regulation expressly calls for the intended travel, working areas, and danger zones. For human-proximity operation, instructions should also cover training, protective measures, residual risks, maintenance access, warning devices, and operating limits needed for safe use.
Keep the risk assessment, EHSR mapping, drawings, control-system descriptions, test reports, standards list, software version evidence, cybersecurity rationale, and instructions together.
Include source code or programming logic for safety-related software in the evidence strategy so authority requests can be answered without improvising.
For machinery or related products, retain the EU declaration of conformity and technical documentation for at least 10 years after placement on the market or putting into service.
For partly completed machinery, ensure assembly instructions state the incorporation conditions needed to avoid compromising health and safety.
Supports technical documentation content, risk analysis, instructions for autonomous mobile machinery, retention, and assembly-instruction requirements.
Supports documenting and verifying the machinery risk assessment and risk reduction process.
documentation and verification
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Section 5
Conformity-route implications
Autonomous or collaborative capability does not by itself prove that a notified body is required. The conformity route depends on whether the machinery or related product is listed in Annex I and, for Annex I Part B, whether applicable harmonised standards or common specifications cover all relevant EHSRs for that category and have been applied.
The route record should therefore separate three questions: whether the product is in Annex I Part A, whether it is in Annex I Part B, and whether all relevant EHSRs are covered by applied harmonised standards or common specifications. Substantial digital or physical modifications that create a new hazard or increase an existing risk can make the modifier a manufacturer and require a new conformity assessment for the affected machinery.
If the category is Annex I Part A, use one of the notified-body routes specified by Article 25 for that category.
If the category is Annex I Part B, check whether harmonised standards or common specifications specific to that category cover all relevant EHSRs and were applied.
If the category is not in Annex I, document why internal production control under Module A is the selected route.
For substantial modifications, document the safety impact, affected parts of an assembly, new hazards or increased risks, and the conformity procedure selected.
Apply the Regulation from 20 January 2027. For a product placed on the market before that date, preserve the Directive 2006/42/EC release evidence and do not assume that later autonomy, control-software, work-area, human-proximity, sensor, remote-supervision, or charging changes stay within the original assessment.
Reopen the assessment when intended travel or working areas change, people enter a previously separated zone, a safety function or software version changes, remote commands expand, a new trailer or tool is integrated, a cyber threat can affect safety, an incident exposes a missed hazard, or the coverage or Official Journal of the European Union (OJEU) citation status of an applied standard changes.
Supports Annex I Part A and Part B conformity routes, Module A for non-Annex I categories, substantial-modification manufacturer obligations, the 20 January 2027 application date, and the presumption-of-conformity conditions for harmonised standards.
Primary legal source for autonomous mobile machinery definitions, EHSRs, control systems, cybersecurity-related safety requirements, technical documentation, and conformity assessment routes.
Defines autonomous mobile machinery, supervisor, supervisory function, conditions for remote supervisory actions and operation, and instructions for autonomous travel, working areas, and danger zones.
Sets EHSRs for visibility, mobile machinery movement, warning devices, impact and crushing risks, and risks to exposed persons.
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Supports software safety-component scope, software update risk assessment, protection against corruption, control-system reliability, automatic-charging hazards, and safety-related software documentation requests.
Supports technical documentation content, risk analysis, instructions for autonomous mobile machinery, retention, and assembly-instruction requirements.
Supports Annex I Part A and Part B conformity routes, Module A for non-Annex I categories, substantial-modification manufacturer obligations, the 20 January 2027 application date, and the presumption-of-conformity conditions for harmonised standards.