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.
EU MR 2023/1230 Conformity Assessment
This is the meta-pattern that wraps every product-specific pattern when shipping into the EU. It covers the full conformity assessment workflow under the EU Machinery Regulation 2023/1230 (applies January 20, 2027), with emphasis on self-propelled machinery — AMRs, mobile manipulators, autonomous service robots — where the substantial-modification, AI-component, and cybersecurity provisions land hardest. Read alongside the product-specific pattern for your machinery class (industrial robot, cobot, AMR).Scenario
You ship machinery into the EU after January 20, 2027. You need to claim conformity under EU MR 2023/1230 and (for Annex I high-risk machinery) involve a notified body. The conformity assessment culminates in a Declaration of Conformity (DoC) that you issue and CE-marking you affix.The conformity-assessment workflow
Prerequisites
| Element | Owner | Roboticks role |
|---|---|---|
| Risk assessment per ISO 12100 | Safety engineer | Ingests hazard list as hazards.yaml; links requirements to hazards |
| Harmonised standards selection | Compliance lead + safety engineer | Pinned in Roboticks; tracked by the publication feed |
| Requirement derivation | Engineering + compliance | Native Roboticks function |
| Verification | Engineering | Native Roboticks function |
| Design drawings and engineering documentation | Mechanical / electrical engineering | Attach to pack as supplementary; not authored by Roboticks |
| Instructions for use | Technical writing | Off-platform; reference from pack |
| Supplier certifications for safety components | Component suppliers | Reference in architecture.yaml |
| Quality management system documentation | Quality function (ISO 9001) | Off-platform |
| Notified body engagement (Annex I machinery) | Compliance | They ingest the evidence pack as part of the technical file |
| Declaration of Conformity | Compliance / company officer | Off-platform; pack provides verification evidence |
| CE marking | Compliance | Off-platform |
The harmonised standards stack
The exact stack depends on machinery class. For most robotics applications:| Standard | Coverage |
|---|---|
| ISO 12100 | Risk assessment methodology |
| EN ISO 13849-1 | PL determination, Categories |
| IEC 62061 | SIL CL determination (alternative to ISO 13849) |
| ISO 10218-1:2025 | Industrial robots (manufacturer side) |
| ISO 10218-2:2025 | Industrial robot systems (integrator side) |
| ISO/TS 15066 | Cobot PFL |
| ISO 3691-4 | Driverless industrial trucks / AMRs |
| IEC 61496 | Protective equipment (scanners, light curtains) |
| EN 60204-1 | Electrical equipment of machinery |
| EU AI Act (Reg 2024/1689) | AI safety components (from 2 August 2027) |
Project setup
Ingest the risk assessment
Hazard list →
roboticks/hazards.yaml. See ISO 12100.Author requirements derived from EHSRs
For machinery-specific obligations not fully covered by the harmonised stack, derive requirements directly from EU MR 2023/1230 Annex III EHSRs. See EU MR 2023/1230.
Technical file structure
Annex IV of EU MR 2023/1230 prescribes what the technical file must contain. The mapping to Roboticks:| Annex IV requirement | Roboticks contribution |
|---|---|
| Risk assessment | hazards.yaml, rendered in the evidence pack PDF |
| List of EHSRs and harmonised standards applied | Pinned-standards section of the pack |
| Design and manufacturing drawings | Attach as supplementary artefacts; not authored |
| Description of safety functions | architecture.yaml, rendered in the pack |
| Calculations and test results | Test-results section, coverage section, MCAPs (referenced) |
| Software safety analysis | Coverage, SARIF, requirement-test traceability |
| Quality management system documentation | Off-platform; reference in DoC |
| Components used (with certifications) | architecture.yaml; referenced supplier certs |
| Instructions for use | Off-platform; reference in DoC |
| Cybersecurity analysis (new under 2023/1230) | SBOM, SARIF, fuzz-test evidence |
| AI safety analysis (new under 2023/1230) | AI-related requirements with their test evidence; MCAPs of AI behaviour |
Conformity-assessment routes
For Annex I high-risk machinery (the list includes safety components, machinery embodying machine-learning, etc.), the notified body involvement is mandatory. The routes:- Annex IX — EU-type examination + production-conformity surveillance — notified body examines the type, then audits production-monitoring evidence annually.
- Annex X — Full quality assurance — notified body audits the quality management system and design dossier.
Cutting the conformity release
When you are ready to declare conformity:Cut the conformity release
rbtk release cut --tag conformity-2027-01-20 --commits …. Use a tagging convention that makes conformity releases identifiable.Run full verification
Every required test, against the pinned commit set. Resolve every gap. Acknowledged gaps must have documented rationale.
Assemble the technical file around it
Off-platform. Drawings, instructions, supplier certs, risk-assessment narrative.
Engage the notified body (if Annex I)
Hand over the pack via the customer-handoff procedure.
On notified-body sign-off, issue the DoC and affix CE
Off-platform; the pack is the verification-evidence record.
Surveillance and re-conformity
Under Annex IX, annual production-conformity surveillance is the norm. Roboticks supports this by:- Producing evidence packs for every release shipped during the surveillance period.
- Maintaining the hash chain so the assessor can verify the historical integrity in a single command.
- Surfacing standard amendments that occurred during the surveillance period and the re-conformity actions taken.
Next steps
EU MR 2023/1230 standard
The Regulation reference.
Industrial robot pattern
Product-specific layer for industrial robots.
AMR pattern
Product-specific layer for AMRs.
Re-conformity workflow
Handling amendments after the conformity release.