Artifact GuideEU

EU Machinery Regulation Transition from Directive 2006/42/EC

Regulation (EU) 2023/1230 repeals Directive 2006/42/EC with effect from 20 January 2027 and applies from the same date.

Use this guide to sort machinery and related-product pipeline decisions, update declarations and technical documentation, and review software, cybersecurity, digital instructions, standards, and partly completed machinery records before the changeover.

Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Sections
4

Structured answer sets in this page tree.

Primary sources
4

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

The transition is not a simple certificate refresh. Each machinery model, related product, and partly completed machinery file needs a dated placement decision, a Directive 2006/42/EC or Regulation (EU) 2023/1230 conformity basis, and a record showing whether declarations, instructions, standards references, technical documentation, and software-related evidence are ready for 20 January 2027.

Section 1

Set the 20 January 2027 changeover baseline

The corrected Machinery Regulation baseline is 20 January 2027. Article 51 repeals Directive 2006/42/EC with effect from that date, Article 54 makes Regulation (EU) 2023/1230 apply from that date, and Article 52 protects products placed on the market in conformity with Directive 2006/42/EC before that date from being blocked for the aspects covered by the Regulation.

Build the transition register around the placement date, not only the shipment or project date. The Commission machinery page states that machinery placed on the EU market before 20 January 2027 must comply with the current Machinery Directive 2006/42/EC and may also state conformity with Regulation (EU) 2023/1230 on the EU Declaration of Conformity where applicable.

  • Classify each model as already placed on the EU market before 20 January 2027, planned for placement before that date, or planned for placement or putting into service from that date.
  • Keep the Directive 2006/42/EC evidence package for pre-20 January 2027 placement decisions, including the declaration, technical file, instructions, harmonised standards, and any EC type-examination certificate or approval decision.
  • For products crossing the changeover, record whether the declaration stays Directive-only, includes an additional Regulation (EU) 2023/1230 conformity statement before 20 January 2027, or moves to a Regulation-only conformity basis from 20 January 2027.
  • Use the corrected 20 January 2027 date consistently across repeal, transitional, application, declaration, standards, and technical-documentation planning.
Section 2

Update declarations, standards, and technical documentation

From the Regulation side, manufacturers of machinery and related products must draw up Annex IV Part A technical documentation, run or obtain the relevant conformity assessment, draw up the EU declaration of conformity, and affix CE marking when compliance with Annex III essential health and safety requirements has been demonstrated.

The transition review should therefore compare the Directive file against the Regulation file item by item. Annex IV Part A calls for a complete product description, intended use, risk assessment, applicable EHSR list, protective measures and residual risks, drawings and explanations, applied harmonised standards or common specifications, test and inspection evidence, production conformity measures, instructions, incorporated-product declarations, and software or sensor/autonomous-system information where applicable.

  • Replace copied standards lists with a model-specific list showing each harmonised standard or common specification applied, whether it is applied fully or partly, and what other technical specification fills any gap.
  • Check whether the file uses Machinery Directive references, Annex ZA language, or declaration wording that must be mirrored, separated, or updated for Regulation (EU) 2023/1230.
  • For partly completed machinery, prepare Annex IV Part B technical documentation, assembly instructions, and an EU declaration of incorporation instead of treating the file as a finished-machine declaration package.
  • Keep technical documentation and the relevant declaration available for at least 10 years after placing on the market or putting into service, as applicable.
Recommended next step

Review your Machinery Regulation transition file

Turn each machinery model's Directive 2006/42/EC file into a Regulation (EU) 2023/1230 transition record covering placement date, declaration wording, standards, technical documentation, digital instructions, and software evidence.

Section 3

Review digital instructions, software, cybersecurity, and autonomous features

The Regulation adds transition work for digital product records. Instructions for machinery and related products may be provided in digital format, but the file must show how users access them, that users can print, download, save, and access them during breakdowns, and that online access is maintained for the expected lifetime and at least 10 years after placing on the market. Non-professional-user safety information still needs paper-format handling under the Regulation.

Software and data-driven functions also need a documented review. The Regulation defines safety components to include digital components and software, defines substantial modification to include physical or digital changes, requires source code or programming logic for safety-related software in the technical documentation where needed for authority checks, and asks for system characteristics, limitations, data, development, testing, and validation descriptions for sensor-fed, remotely driven, or autonomous machinery where safety-related operations are controlled by sensor data.

  • Inventory every model with embedded software, downloadable configuration, safety-related software, remote operation, sensor-fed safety operation, autonomous behaviour, or digital updates after placement.
  • Update the risk assessment and EHSR checklist for digital changes that create a new hazard, increase an existing risk, or alter the protective measures relied on in the technical file.
  • Keep source-code or programming-logic access procedures ready for reasoned competent-authority requests, while limiting the record to what is necessary to check Annex III compliance.
  • Use cybersecurity and IT-security standards work as supporting engineering input where relevant, but do not treat cybersecurity references as a substitute for the Regulation's own EHSR, technical-documentation, and conformity-assessment evidence.
Section 4

What to review before freezing the transition file

A useful transition file should let a reviewer trace one product from scope to market placement to evidence. The minimum review is the product identity, role, market placement date, applicable legal basis, EHSR mapping, standards position, conformity route, declaration wording, instructions format, software and digital-change position, and open actions before 20 January 2027.

For pipeline and legacy products, preserve the reason why the Directive file remains sufficient or why a Regulation update is needed. For new or changed products, close the gaps that affect the Regulation file before release: missing Annex IV evidence, stale standards references, incomplete digital instruction access, unsupported dual conformity statements, absent partly completed machinery assembly instructions, or software evidence that cannot be produced if a competent authority asks for it.

  • Confirm whether the product is machinery, a related product, or partly completed machinery, and whether any more specific Union harmonisation legislation covers the same risk.
  • Compare the Directive 2006/42/EC technical file with the Regulation (EU) 2023/1230 Annex IV file structure and record every missing or changed item.
  • Check EC type-examination certificates and approval decisions issued under Directive 2006/42/EC for expiry and transition assumptions; Article 52 keeps them valid until they expire.
  • Review whether digital instructions, digital declarations, QR or internet-address access, translations, paper safety information for non-professional users, and 10-year online availability are implemented for the intended product and user group.
  • Escalate unresolved standards gaps, notified-body needs, safety-related software evidence, sensor/autonomous validation records, or substantial-modification conclusions before release approval.
Primary sources

References and citations

eur-lex.europa.eu
Referenced sections
  • Legacy legal source for the Directive-side conformity file, declaration, technical documentation, instructions, and harmonised-standards position before the Regulation changeover.
"on machinery"
single-market-economy.ec.europa.eu
Referenced sections
  • Grounds the transition statement that manufacturers may state Regulation conformity on the EU Declaration of Conformity before 20 January 2027 if applicable.
"also conforms with Machinery Regulation (EU) 2023/1230"
iso.org
Referenced sections
  • Grounds the availability of machinery-safety guidance on IT-security and cybersecurity aspects related to ISO 12100.
"consideration of related IT-security (cyber security) aspects"
eur-lex.europa.eu
Referenced sections
  • Grounds Article 52 certificate continuity, Annex IV technical-documentation checks, and digital declaration and instruction review points.
"shall remain valid until they expire"
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