Applies 20 Jan 2027EU MR 2023/12302023 (applies 20 January 2027)

Regulation (EU) 2023/1230 — Machinery Regulation

Applies to: Machinery, partly completed machinery, related products placed on the EU market

Regulation (EU) 2023/1230 (the "Machinery Regulation") replaces the 2006 Machinery Directive on 20 January 2027. It explicitly adds cybersecurity essential health and safety requirements (EHSRs), brings AI-system safety and self-evolving machinery into scope, and modernises conformity assessment for software-updated and connected products. For robotics teams shipping into the EU, this is the proximate compliance forcing function.

Audit-readiness, not certified. Roboticks is not itself a certified verification tool. Conformity assessment is the manufacturer's responsibility (with notified-body involvement where required). We assemble the verification evidence your assessor reads.

What's actually new

Annex III adds new EHSRs covering: (1) protection against corruption of safety functions (cybersecurity); (2) safety of machinery embedding AI systems; (3) information for safe use including digital instructions; (4) traceability and identifiability for software components. Conformity assessment under Annex IV explicitly covers connected and learning machinery. Substantial modifications trigger re-conformity.

Who's affected

Manufacturers, importers, distributors, and authorised representatives placing machinery on the EU market. Industrial robots and cobots (mostly), AMRs and AGVs (mostly via being machinery), autonomous mobile platforms (yes when not type-approved as vehicles), surgical robots (separate medical device regs apply primarily but machinery aspects in scope).

What changes vs the 2006 Directive

Cybersecurity EHSRs become explicit. AI systems in safety functions get a dedicated provision. Digital instructions for use are explicitly allowed. Substantial modifications (including via software update) require re-assessment. Annex I high-risk list now includes machinery with self-evolving behavior and machinery embedding AI safety functions.

How Roboticks helps with audit-readiness

Ingest your requirements (often derived from EN 60204-1, ISO 12100, ISO 10218, ISO 13849, and the regulation's Annex III). Link tests via @confirms; the matrix shows live coverage. Evidence pack at release time bundles JUnit + SARIF + ReqIF + MCAP into a hash-chained ZIP that the conformity assessor can verify. We are not a certified tool; we assemble the evidence the assessor reads.

Examples of derivable requirements

These are example requirements you could derive from EU MR 2023/1230 and link to verifying tests via the @confirms decorator. Not exhaustive and not a substitute for a domain-expert risk assessment.

EU-MR-1.2.1

Safety and reliability of control systems (Annex III §1.2.1)

Control systems must be designed so that fault conditions do not lead to dangerous situations. Verifiable via fault-injection tests on safety functions (e.g. emergency stop reachability under simulated bus disconnection).

EU-MR-1.1.9

Protection against corruption (Annex III §1.1.9, new)

Cybersecurity essential health and safety requirement. Verifiable via SARIF static analysis, threat modeling artifacts, SBOM, and tests covering message authentication on safety-critical topics.

EU-MR-1.1.6

Ergonomics and AI behavior (Annex III §1.1.6, expanded)

Machinery embedding AI systems intended to safeguard safety functions must be verifiable, with documentation of the AI's behavior. Typically verifiable via sim-in-the-loop scenario coverage plus inference-output regression tests.

Frequently Asked Questions

Get started

Ingest EU MR 2023/1230 as a ReqIF export from your requirements tool, or as a PDF for the LLM extractor. Link tests via @confirms. Watch the matrix turn green as PRs land.

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