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
The harmonised standards stack
The exact stack depends on machinery class. For most robotics applications:
Conformance to harmonised standards confers a presumption of conformity to the corresponding EHSRs of EU MR 2023/1230. The presumption is rebuttable; the notified body assessment is the rebuttal opportunity.
Project setup
1
Pin EU MR 2023/1230 and the harmonised stack
2
Ingest the risk assessment
Hazard list →
roboticks/hazards.yaml. See ISO 12100.3
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.
4
Author cybersecurity and AI requirements
EU MR 2023/1230’s cybersecurity provisions (EHSR 1.1.9) and AI provisions (EHSR 1.1.6, 1.2.1) require explicit requirement-and-test coverage. The harmonised stack does not fully cover them; derive directly from the Regulation.
Technical file structure
Annex IV of EU MR 2023/1230 prescribes what the technical file must contain. The mapping to Roboticks:
The evidence pack is the verification evidence portion of the technical file — typically the most voluminous portion, and the one notified bodies most scrutinise. The non-verification portions are off-platform; you assemble them around the pack.
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:1
Cut the conformity release
rbtk release cut --tag conformity-2027-01-20 --commits …. Use a tagging convention that makes conformity releases identifiable.2
Run full verification
Every required test, against the pinned commit set. Resolve every gap. Acknowledged gaps must have documented rationale.
3
Generate the evidence pack
All three formats; include screenshots if available.
4
Assemble the technical file around it
Off-platform. Drawings, instructions, supplier certs, risk-assessment narrative.
5
Engage the notified body (if Annex I)
Hand over the pack via the customer-handoff procedure.
6
On notified-body sign-off, issue the DoC and affix CE
Off-platform; the pack is the verification-evidence record.
7
Mark the release shipped
rbtk release ship conformity-2027-01-20. The 10-year retention clock starts.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.