Artifact GuideEU

EU Machinery Regulation Autonomous Mobile and Collaborative Machinery

Regulation (EU) 2023/1230 expressly addresses , software-enabled safety components, safety-related control systems, protection against corruption, and technical documentation for safety-related software.

Scope autonomous travel, remote supervision, human proximity, collaborative operation, safety controls, cybersecurity evidence, and the applicable conformity route.

Author
Sorena AI
Published
May 9, 2026
Updated
Oct 15, 2026
Overview

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.

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.
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.
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.
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.

Section 4

Technical documentation and instructions

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.
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.
Primary sources

References and citations

eur-lex.europa.eu6 citations
Referenced sections
  • 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.
Show 3 more
  • 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.
"Autonomous mobile machinery"
More quoted passages
"without permanent interaction of an operator"
"risk of impact or crushing"
"source code or programming logic"
"analysis and assessment of the risk(s)"
"shall apply one of the following procedures"
iso.org3 citations
Referenced sections
  • Source for machinery risk assessment, risk reduction, documentation, and verification concepts.
  • Source for machinery risk assessment, risk reduction, documentation, and verification concepts used to structure the evidence pack.
  • Supports documenting and verifying the machinery risk assessment and risk reduction process.
"risk assessment and risk reduction"
More quoted passages
"documentation and verification"
iso.org2 citations
Referenced sections
  • Source listing machinery safety standards, including risk assessment and safety-related control-system families.
  • Lists safety-related parts of control systems standards, including ISO 13849 entries relevant to control-system design and validation evidence.
"Safety of machinery"
More quoted passages
"Safety-related parts of control systems"
iso.org2 citations
Referenced sections
  • Source for considering IT-security and cybersecurity aspects in machinery safety work.
  • Source for considering IT-security and cybersecurity aspects in relation to machinery safety and ISO 12100.
"cyber security"
More quoted passages
"IT-security (cyber security) aspects"
webgate.ec.europa.eu2 citations
Referenced sections
  • Source for locating notified bodies for Regulation (EU) 2023/1230 when the selected conformity route requires one.
  • Source for checking notified bodies listed for Regulation (EU) 2023/1230 conformity assessment activities.
"conformity assessments"
More quoted passages
"find Bodies notified"

Directive 2006/42/EC to Machinery Regulation transition

Transition guide for moving EU machinery files from Directive 2006/42/EC to Regulation (EU) 2023/1230, focused on the 20 January 2027 changeover, pipeline products, declarations, standards, technical documentation, software, cybersecurity, and digital instructions.

EU Machinery Regulation Applicability Test

Test whether a product is machinery, a related product, partly completed machinery, a safety component, substantially modified, excluded, or covered by overlapping EU product laws.

EU Machinery Regulation compliance

Machinery Regulation compliance checklist covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, software, transition, and market surveillance.

EU Machinery Regulation compliance checklist

Checklist for Regulation (EU) 2023/1230 covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, digital duties, transition, and market surveillance.

EU Machinery Regulation deadlines and compliance calendar

Calendar for Regulation (EU) 2023/1230 dates, Directive 2006/42/EC transition, release documentation gates, standards monitoring, and substantial-modification reviews.

EU Machinery Regulation FAQ

Answers to Machinery Regulation questions on scope, partly completed machinery, Annex I categories, Article 25 conformity assessment, digital instructions, software, cybersecurity, transition, CE files, and overlap with other EU product laws.

Show all related guides (40)

EU Machinery Regulation Partly Completed Machinery

What counts as partly completed machinery under Regulation (EU) 2023/1230, what documents travel with it, and where the final assembler takes over.

EU Machinery Regulation requirements

Requirements under Regulation (EU) 2023/1230: machinery scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declaration, CE marking, software evidence, transition, and surveillance.

EU Machinery Regulation Safety Components

Definition, scope, conformity assessment, technical documentation, declaration, CE marking, and cited examples for safety components under Regulation (EU) 2023/1230.

EU Machinery Regulation scope and machine categories

Scope guide for Regulation (EU) 2023/1230 covering machinery, related products, partly completed machinery, Annex I categories, exclusions, substantial modification, and category evidence.

EU Machinery Regulation substantial modification decision workflow

Workflow for assessing substantial modification under Regulation (EU) 2023/1230: change facts, hazard and risk impact, manufacturer obligations, conformity assessment, CE marking, and evidence.

EU Machinery Regulation vs LVD

Compare the EU Machinery Regulation and Low Voltage Directive boundary for machinery EHSRs, electrical risks, excluded electrical products, CE documentation, and evidence reuse.

EU Machinery Regulation vs Market Surveillance Regulation: compliance comparison

Compare Machinery Regulation product compliance duties with EU MSR market surveillance duties, authority requests, online sales, corrective action and evidence records.

EU Machinery Regulation: when does a modification constitute substantial modification?

Guide to substantial modification under Regulation (EU) 2023/1230: change triggers, risk assessment, EHSRs, technical documentation, conformity assessment, CE marking, and records.

EU Machinery Risk Assessment Method

How to document an EU Machinery Regulation risk assessment: ISO 12100 hazard identification, EHSR mapping, risk reduction, residual risk, software, cybersecurity, and technical-file evidence.

Machinery CE documentation template for Regulation (EU) 2023/1230

Template fields for Machinery Regulation CE documentation: product identity, scope, EHSR risk assessment, standards, tests, instructions, EU declaration, CE marking, notified body route, software, cyber, and substantial modification checks.

Machinery Regulation Annex I conformity route workflow

Classify machinery against Annex I Part A and Part B, choose the Article 25 conformity assessment route, and assemble the technical evidence file.

Machinery Regulation Annex I high-risk categories

Explain what Annex I does under Regulation (EU) 2023/1230, which listed machinery categories trigger special conformity routes, and what evidence to keep.

Machinery Regulation category and scope checks

Check whether a product is machinery, a related product, partly completed machinery, a safety component, excluded from scope, or listed in Annex I under Regulation (EU) 2023/1230.

Machinery Regulation conformity assessment and CE marking

EU Machinery Regulation guide to Article 25 conformity assessment routes, Annex I machinery categories, technical documentation, EU declarations, CE marking, and instructions.

Machinery Regulation digital instructions

EU Machinery Regulation guide to digital instructions for use: access marking, print and download access, paper copies, non-professional safety information, languages, and records.

Machinery Regulation penalties and enforcement

EU Machinery Regulation enforcement guide covering Member State penalty rules, corrective action, market surveillance powers, and cross-border authority cooperation.

Machinery Regulation related products scope guide

Classify EU Machinery Regulation related products, including interchangeable equipment, safety components, lifting accessories, lifting chains, ropes, webbing, and removable transmission devices.

Machinery Regulation software and cybersecurity considerations

How Regulation (EU) 2023/1230 treats safety-related software, control systems, corruption protection, technical documentation, and cyber-safety risk evidence.

Machinery Regulation Technical Documentation and Technical File

What to keep in the EU Machinery Regulation technical file: product identification, risk assessment, EHSR mapping, standards, tests, instructions, declarations, software evidence, retention, and notified-body records.

Machinery Regulation technical file acceptance workflow

Release-gate workflow for accepting an EU Machinery Regulation technical file: scope, EHSR risk evidence, standards, tests, declarations, notified-body records, software, cyber, and signoff.

Machinery Regulation Timeline and Transition: practical guide

EU Machinery Regulation timeline covering corrected application dates, the Directive 2006/42/EC changeover, certificate continuity, product placement decisions, and transition evidence.

Machinery Regulation vs EMC Directive

Compare EU machinery safety duties with EMC duties for equipment, CE documentation, harmonised standards, declarations, and combined technical files.

Machinery Regulation vs EU AI Act: machinery safety overlap

A cited-source comparison of the EU Machinery Regulation and EU AI Act for machinery with AI-enabled safety functions, software, cyber-safety and technical documentation overlap.

Machinery Regulation vs Machinery Directive

Official source comparison of Regulation (EU) 2023/1230 and Directive 2006/42/EC across legal form, timing, scope, digital instructions, cybersecurity, conformity assessment, documentation, and CE marking.

Machinery vs RED comparison

Compare EU Machinery Regulation and Radio Equipment Directive boundaries for machinery safety, radio equipment scope, CE documentation, and shared evidence.

Declaration of Conformity vs Declaration of Incorporation | Machinery Regulation FAQ

FAQ on when machinery needs an EU Declaration of Conformity and when partly completed machinery needs an EU Declaration of Incorporation under Regulation (EU) 2023/1230.

How to map Annex III EHSRs under the EU Machinery Regulation | Machinery Regulation FAQ

FAQ on mapping Annex III essential health and safety requirements to hazards, risk reduction, software controls, technical documentation, and Annex I classification under Regulation (EU) 2023/1230.

Machinery Regulation and EU AI Act overlap for AI-enabled safety functions

FAQ on Machinery Regulation overlap with the EU AI Act for self-evolving or machine-learning safety functions, Annex I categories, standards work, and technical documentation boundaries.

Machinery Regulation cybersecurity evidence FAQ

What cybersecurity evidence connected or software-enabled machinery should keep for protection against corruption, safety-related control systems, and machinery risk assessment.

What counts as machinery under Regulation (EU) 2023/1230?

FAQ on the Machinery Regulation definition of machinery, including assemblies, drive systems, missing components, software, related products, partly completed machinery, safety components, and exclusions.

When can a software update affect Machinery Regulation compliance?

FAQ on when machinery software updates can trigger Machinery Regulation review, including safety functions, substantial modification, corruption protection, instructions, and CE technical-file evidence.

When does used or modified machinery need a new conformity assessment? | Machinery Regulation FAQ

FAQ on used and modified machinery under Regulation (EU) 2023/1230, including substantial modification, first EU use, technical documentation, and market surveillance evidence.

When is a notified body needed under the EU Machinery Regulation?

FAQ on when Machinery Regulation Annex I products need a notified body, how to find designated bodies, and what manufacturers still own.

Which Article 25 conformity assessment module applies? | EU Machinery Regulation FAQ

FAQ on Article 25 of Regulation (EU) 2023/1230: Module A, Module B plus C, Module H, Module G, Annex I triggers, notified body involvement, and technical file evidence.