EU Machinery Regulation Transition from Directive 2006/42/EC

The corrected Machinery Regulation baseline is 20 January 2027. Article 51 repeals Directive 2006/42/EC with effect from that date, and Article 54 makes Regulation (EU) 2023/1230 generally apply from that date. Article 52 prevents Member States from impeding the later making available of products that were placed on the market in conformity with Directive 2006/42/EC before the cutoff. That protection is unit-specific: it does not grandfather every unit of the same model, stock that was only manufactured or warehoused, or a product planned for later placement. Chapter VI of the Regulation, on market surveillance and safeguard procedures, already applies to those Directive-compliant products as specified in Article 52. A 4 July 2023 corrigendum corrected the original dates, so use the current consolidated EUR-Lex text rather than an uncorrected copy.

Regulation (EU) 2023/1230 covers machinery; related products comprising interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing for lifting, and removable mechanical transmission devices; and partly completed machinery. Article 2 excludes specified products, including certain identical spare safety components supplied by the original manufacturer, fairground equipment, some nuclear, military, police, temporary laboratory-research, transport, electrical, electronic, and high-voltage products. Some exclusions are limited: machinery mounted on otherwise excluded vehicles or means of transport can remain in scope, and Article 9 disapplies the Regulation only to the extent that more specific Union harmonisation legislation covers the same risk.

Build the transition register around first EU market placement or, for machinery and related products, first intended use in the Union. A shipment, warehouse receipt, purchase order, model launch, or completed manufacture does not by itself answer whether a unit was first supplied on the Union market. The Commission states that machinery placed before 20 January 2027 must comply with Directive 2006/42/EC and may also state Regulation conformity on the EU declaration where applicable; any dual statement still needs evidence for both claims.

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.

Choose the conformity route from Article 25. Annex I Part A categories require EU type-examination followed by conformity to type, full quality assurance, or unit verification. Annex I Part B categories may use internal production control only when the product is designed and constructed in accordance with harmonised standards or common specifications specific to the category and covering all relevant essential health and safety requirements; otherwise one of the notified-body routes applies. Machinery and related products outside Annex I use internal production control. Partly completed machinery follows Article 11 instead: Annex IV Part B technical documentation, assembly instructions, and an EU declaration of incorporation.

Harmonised standards remain voluntary. Under Article 20, conformity with a standard or part whose reference is published in the Official Journal of the European Union creates a presumption of conformity only for the Annex III requirements that it covers. The manufacturer must address every remaining requirement through other technical evidence. A Commission common specification can create the same limited presumption when Article 20's conditions are met.

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 essential health and safety requirement 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. The Regulation's Annex XII correlation table helps locate successor provisions but does not prove that an old file satisfies the new requirement.

Instructions for machinery and related products may be digital, but the file must show how users access them, that users can print, download, save, and reach them during breakdowns, and that online access lasts for the expected lifetime and at least 10 years after market placement. A user who asks at purchase must receive paper instructions free of charge within one month. Machinery intended for non-professional users, or foreseeably usable by them, must include on paper the safety information essential for putting it into service and using it safely.

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.

A separate AI-related change is now part of transition planning. Regulation (EU) 2026/1744 was published on 24 July 2026 and entered into force on 27 July 2026. It requires the Commission to adopt delegated acts adding Annex III health and safety requirements for AI systems classified as high-risk under Article 6(1) of the AI Act because they are a safety component in a Machinery Regulation product or are themselves such a product. Those delegated acts must apply by 2 August 2028. Until machinery harmonised standards or common specifications for high-risk AI are referenced or adopted under Article 20, compliance with relevant harmonised standards referenced under AI Act Article 40, or common specifications adopted under Article 41, gives a presumption of conformity with the AI-related Annex III requirements. Do not treat the future delegated requirements as if they were already written into Annex III; track the adopted delegated acts and their application date.

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.