03 · Machinery Regulation

Regulation (EU) 2023/1230 on Machinery

Bilingual EN / 中文 guide to scope, key changes, conformity routes, timeline and reference documents for the new EU Machinery Regulation.

Regulation Overview

Regulation (EU) 2023/1230 replaces the Machinery Directive

Adopted on 14 June 2023 and published in the Official Journal as Regulation (EU) 2023/1230, the new Machinery Regulation repeals Directive 2006/42/EC and Directive 73/361/EEC. It applies in full from 20 January 2027 and — as a Regulation rather than a Directive — is directly binding in every Member State without national transposition. It modernises essential health and safety requirements (EHSRs) for machinery, related products and partly completed machinery, and addresses new risks introduced by digitalisation, AI and connectivity.

Adopted

14 Jun 2023

Entry into force

19 Jul 2023

Full application

20 Jan 2027

Timeline

From adoption to full application

14 Jun 2023

Regulation (EU) 2023/1230 adopted by the European Parliament and Council.

29 Jun 2023

Published in the Official Journal of the EU; entry into force 20 days later.

20 Jan 2027

Full application — Directive 2006/42/EC repealed; new Regulation becomes the only legal basis for placing machinery on the EU market.

Transitional

Machinery placed on the market before 20 Jan 2027 under 2006/42/EC remains valid; new placements must comply with the Regulation.

Scope

What the Regulation covers

Machinery (assemblies fitted with a drive system other than directly applied human or animal effort)

Related products: interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices

Partly completed machinery

Software ensuring safety functions, including AI systems intended as safety components

Substantial modifications to machinery already placed on the market

What's New

Six headline changes vs. Directive 2006/42/EC

Cybersecurity & connectivity

New EHSRs address protection against corruption of safety functions through connectivity and remote access.

Artificial intelligence

Self-evolving behaviour and AI-based safety functions are explicitly covered, with traceability and risk-assessment duties.

Substantial modification

Defines when modification triggers a new conformity assessment — relevant to retrofits and used machinery.

Digital instructions allowed

Instructions for use, EU declaration of conformity and assembly declarations may be supplied in digital form (paper available on request).

High-risk Annex I list revised

Annex I splits machinery into Part A (mandatory third-party assessment) and Part B (choice of conformity routes), with new categories such as ROPS, FOPS and certain logging machines.

Stronger market-surveillance & traceability

Aligned with Regulation (EU) 2019/1020 — clearer obligations across manufacturers, authorised representatives, importers and distributors.

Conformity Routes

Choose the right assessment module

Module A

Internal production control (Module A)

Manufacturer self-assessment for non-Annex-I machinery — technical file, EU DoC and CE marking.

Module B+C

EU type-examination + conformity to type

Required for Annex I Part A machinery without full application of harmonised standards. Notified Body assessment.

Module H

Full quality assurance (Module H)

Notified Body audits the manufacturer's quality system covering design, manufacture and final inspection.

Module G

Unit verification (Module G)

Used for one-off machinery — Notified Body verifies the individual unit against the Regulation.

How We Help

End-to-end support to be 2023/1230-ready

Gap analysis vs. 2006/42/EC

Map current technical files, risk assessments and instructions against the new EHSRs and identify required updates.

Risk assessment & technical file

EN ISO 12100-aligned risk assessment, harmonised-standard application analysis and Annex IV technical file build-up.

Cybersecurity & AI safety integration

Bridge ISO/SAE 21434, IEC 62443 and AI-Act requirements into the machinery safety case.

Notified Body type-examination support

Routing through group-affiliated EU Notified Body NB 2406 (ENAVE, Italy) — dossier preparation and witness-test execution.

EU DoC, CE marking & instructions

Drafting and review of EU Declaration of Conformity, CE-marking layout and digital / paper instruction sets.

Authorised representative & post-market

EU-based authorised-representative service and post-market obligations: complaints, corrective actions and surveillance liaison.

Downloadable References

Official texts and guidance

Regulation (EU) 2023/1230 — full text (EUR-Lex)

Official consolidated text · all EU languages · PDF / HTML

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1230

EU-OSHA — Machinery Regulation summary

Source page used for this summary

https://osha.europa.eu/en/legislation/directive/regulation-20231230eu-machinery

European Commission — Machinery sector page

Single market for machinery products — guidance & FAQ

https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en

Directive 2006/42/EC (repealed reference)

For gap-analysis comparison until 20 Jan 2027

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32006L0042

Harmonised standards under 2023/1230 (OJEU)

List published by the Commission — updated periodically

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en

Source: EU-OSHA — Regulation 2023/1230/EU on machinery (osha.europa.eu) and EUR-Lex CELEX 32023R1230. Texts © European Union, 1998–present, reused under the conditions stated at eur-lex.europa.eu.

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