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Documentation Index

Fetch the complete documentation index at: https://docs.roboticks.io/llms.txt

Use this file to discover all available pages before exploring further.

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EU Machinery Regulation 2023/1230

Regulation (EU) 2023/1230, published 14 June 2023, applies January 20, 2027. It replaces Directive 2006/42/EC and is the central EU instrument for the placing-on-market and putting-into-service of machinery. It introduces explicit obligations for AI safety, cybersecurity, autonomous functionality, and substantial-modification re-assessment — the changes that matter most for robotics OEMs.
Roboticks is audit-readiness tooling, not a certified toolchain. We assemble the evidence your notified body, certification body, or QA process ingests. We do not replace tool qualification (DO-178C, ISO 26262-8 TCL) and we do not issue conformity assessments. Verify the regulatory interpretations on this page against the standard text and your accredited assessor.

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Scope

Applies to:
  • Machinery, interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices, partly-completed machinery — as defined in Article 3.
  • Robotics: industrial robots, AMRs, cobots, autonomous machinery, machinery with safety-related software including AI components.
The Regulation is directly binding (unlike the prior Directive); no national transposition. The transition is hard: 2006/42/EC continues to apply to machinery placed on the market before 20 January 2027; 2023/1230 applies from that date.

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What changed (vs 2006/42/EC)

AreaNew under 2023/1230
AI componentsNew essential health and safety requirements (EHSRs) for safety-related AI. Risk assessment must cover AI behaviour including evolving behaviour. (Annex III §1.1.6, §1.2.1)
CybersecurityProtection against accidental and intentional corruption of safety functions. Detection of attempts to modify safety control system. (Annex III §1.1.9, §1.2.1)
Autonomous machineryExplicit requirement to ensure safe behaviour in autonomous mode, including handover to/from operator control. (Annex III §1.2.1)
Substantial modificationModifications that change intended use or compromise safety trigger a new conformity assessment. (Article 18)
Digital instructionsInstructions may be supplied digitally; specific durability and accessibility requirements. (Article 10)
High-risk machinery (Annex I)Expanded list including software ensuring safety functions, machinery embodying machine-learning
Notified body involvementHigh-risk machinery (Annex I) must use a notified body for conformity assessment. Self-assessment is restricted.
The harmonised standards list under 2023/1230 is being progressively published in the EU Official Journal. Pinning the Regulation in Roboticks subscribes you to the harmonised-list updates.

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What Roboticks supports

  • Requirement derivation from the Regulation text and the harmonised standards stack. Pin EU MR 2023/1230 along with the harmonised standards your product relies on (typically ISO 12100, EN ISO 13849-1, ISO 10218-1:2025, IEC 62061, IEC 61496 — see Overview).
  • Annex III EHSR coverage. Each EHSR clause becomes an addressable derivation anchor. Author requirements that link to specific EHSRs (e.g., EHSR 1.2.1 for control system safety).
  • Substantial-modification trigger detection. When code changes touch requirements derived from EHSRs governing intended use or safety functions, the change-impact analysis flags them for substantial-modification review.
  • Cybersecurity evidence. The pack includes SBOM (SPDX + CycloneDX), SARIF static-analysis output, and links to fuzz-test results — the inputs a notified body uses to assess Article 5 cybersecurity obligations.
  • AI provisions evidence. Test runs against derived requirements that cover AI behaviour, including reproducible sim runs captured as MCAPs.
  • Technical-file assembly. The evidence pack is structured to map directly onto the Annex IV technical-file requirements; the EU MR conformity pattern walks through this.

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What Roboticks does not do

  • Not a notified body. We do not perform EU-type examinations, do not issue EU-type examination certificates, and are not listed in NANDO.
  • Not a substitute for the Annex IV technical-file assembly. The evidence pack is one input to the technical file; assembly of the full file (declarations, risk assessment narrative, drawings, instructions for use) is your engineering and documentation responsibility.
  • Not a Declaration-of-Conformity tool. We do not generate DoCs. Your compliance staff or QA management issues the DoC against the technical file; the evidence pack is the verification-evidence component.
  • Not legal counsel. Interpretations on this page reflect Roboticks’ understanding of the Regulation and should not be relied on for legal purposes. Engage a qualified consultancy or in-house counsel.

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Example derived requirement

- id: REQ-MR-014
  title: Detection of attempts to modify safety control system
  type: safety
  asil_pl: PLd
  derives_from:
    - standard: eu-mr-2023-1230
      clause: "Annex III, EHSR 1.1.9"
      edition: "2023-06-14"
  text: |
    The safety control system shall detect intentional and accidental
    attempts to modify its configuration, software, or parameters
    affecting safety functions. On detection, the system shall enter
    a safe state and record an audit event including the source,
    method, and timestamp of the attempt.
  acceptance:
    - test: tests/cyber/test_safety_config_tampering.py::test_detects_param_modify
    - test: tests/cyber/test_safety_config_tampering.py::test_enters_safe_state
    - test: tests/cyber/test_safety_config_tampering.py::test_audit_event_recorded
The derivation block tells the platform that REQ-MR-014 exists because EHSR 1.1.9 says so. If the Regulation is amended and EHSR 1.1.9 changes, REQ-MR-014 is automatically flagged for review in the diff view.

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Suggested test patterns

For 2023/1230 EHSRs that robotics customers most often derive against, the recommended test patterns are:
EHSR areaPattern
1.2.1 Safety of control systemsFault injection on control-system inputs; verify safe state via @deadline assertion
1.1.6 AI componentsReproducible sim scenarios captured as MCAPs; coverage of nominal + edge + adversarial inputs
1.1.9 CybersecurityFuzz tests against safety-relevant interfaces; SARIF coverage from static analysis
1.2.4 Modes (autonomous handover)Scenario tests across mode transitions; MCAP capture of state-machine traces
1.3 Mechanical hazardsForce / torque limit tests for cobots (cross-references ISO/TS 15066)
6.3 Functional safetyPL / SIL CL verification tests (cross-references ISO 13849 and IEC 62061)

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Conformity assessment route

For high-risk machinery (Annex I), Article 25 requires notified-body involvement. The conformity assessment procedure typically follows Annex IX (EU-type examination + production-conformity surveillance) or Annex X (full quality assurance). Roboticks evidence packs feed the technical file that the notified body assesses during EU-type examination, and feed the production-monitoring evidence the surveillance assessment reviews. See the EU MR 2023/1230 conformity pattern for the full workflow.

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Pinning

rbtk standard pin eu-mr-2023-1230 --project acme-robotics/firmware
Or via the industrial-robot-eu template (Pinning), which pins 2023/1230 alongside the harmonised standards stack.

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Next steps

EU MR conformity pattern

End-to-end workflow.

ISO 10218-1:2025

The harmonised industrial-robot standard most often cited under MR 2023/1230.

ISO 12100

Foundational risk assessment used in every MR conformity claim.

EU AI Act

Interaction between MR 2023/1230 and the AI Act for AI-component machinery.