EU Machinery Regulation FAQ

Regulation (EU) 2023/1230 applies to machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing for lifting, removable mechanical transmission devices, and partly completed machinery. Those products are grouped in the Regulation as products within its scope.

The scope check should also look for exclusions. Article 2 excludes categories such as certain transport means, seagoing vessels and offshore units, military or police machinery, research machinery for temporary laboratory use, mine winding gear, machinery moving performers during artistic performances, specified electrical and electronic products covered by the Low Voltage Directive or Radio Equipment Directive, and high-voltage switchgear, control gear, and transformers.

The definition is broader than a finished machine with a motor already installed. Article 3 covers linked parts or components where at least one moves and the assembly has, or is intended to have, a drive system other than directly applied human or animal effort. It also covers assemblies missing only site connection components, assemblies ready to function only when mounted on transport or installed in a building or structure, integrated assemblies of machinery, manually powered lifting assemblies, and assemblies missing only the upload of software intended for the manufacturer's specific application.

That last category matters for software-defined products: a physical assembly can be machinery even before the final application software is uploaded if the Regulation's other machinery definition elements are met.

Partly completed machinery is an assembly that is not yet machinery because it cannot by itself perform a specific application and is intended only to be incorporated into or assembled with machinery, other partly completed machinery, or equipment so that the final result forms machinery.

It is not CE-marked as finished machinery under the Machinery Regulation route. Before placing partly completed machinery on the market, the manufacturer must draw up Annex IV Part B technical documentation, demonstrate the relevant Annex III essential health and safety requirements in that technical documentation, provide assembly instructions, and draw up an EU declaration of incorporation under Article 22.

Annex I is split into Part A and Part B. Part A categories require one of the Article 25(2) procedures and do not allow the ordinary internal production control route. Part A includes removable mechanical transmission devices and their guards, vehicle servicing lifts, portable cartridge-operated fixing and other impact machinery, and safety components or embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions.

Part B contains a wider list of machinery categories. For Part B, internal production control is possible only when the product is designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. Otherwise, Article 25 requires a notified-body-involved route.

A notified body is needed when the chosen Article 25 route is EU type-examination followed by conformity to type, full quality assurance, or unit verification. For Annex I Part A, the manufacturer or substantial modifier must use one of those routes. For Annex I Part B, a notified body is needed unless the product can use internal production control because the relevant harmonised standards or common specifications fully cover the category and relevant EHSRs.

If the product is not listed in Annex I, Article 25(4) applies internal production control. Even then, the manufacturer must still draw up technical documentation, perform risk assessment, demonstrate Annex III conformity, issue the EU declaration of conformity, and affix CE marking.

Yes. Article 10 allows instructions for use to be provided in digital format for machinery and related products, and Article 11 allows digital assembly instructions for partly completed machinery. The manufacturer must mark how to access them, provide them in a form the user or incorporator can print, download, and save, and keep them accessible online for the expected lifetime of the machinery or related product and for at least 10 years after placing on the market. For partly completed machinery, digital assembly instructions must remain online for at least 10 years after placing on the market.

Paper is still required in some cases. If the user or incorporator requests paper instructions at purchase, the manufacturer must provide them free of charge within one month. For machinery or related products intended for non-professional users, or reasonably foreseeable to be used by them, essential safety information for putting into service and safe use must be provided in paper format.

The Regulation expressly treats some software and data as safety-relevant. A safety component can be physical or digital, including software. Annex III requires protection against accidental or intentional corruption for safety-critical software, data, and relevant hardware connections, and requires the machinery or related product to identify software necessary for safe operation.

For control systems, Annex III requires resilience against faults, logic errors, foreseeable human error, and reasonably foreseeable malicious attempts from third parties leading to a hazardous situation. For safety software uploaded after placing on the market or putting into service, the tracing log of interventions and versions must be enabled for five years after upload, exclusively for demonstrating conformity to competent authorities on request.

The Machinery Regulation focuses on machinery and related products made available on the market or put into service. For existing products, the key Machinery Regulation trigger is substantial modification after the product has been placed on the market or put into service. Article 3 defines substantial modification as a physical or digital change not foreseen or planned by the manufacturer that affects safety by creating a new hazard or increasing an existing risk and requires specified additional protective measures.

A person carrying out a substantial modification is treated as a manufacturer for that machinery or related product, or for the affected part of an assembly where the risk assessment shows the modification affects only that part. That person must ensure and declare conformity on its sole responsibility and apply the relevant Article 25 conformity assessment procedure. A non-professional user who substantially modifies machinery for their own use is not treated as a manufacturer under Article 18.

The Machinery Regulation does not supersede every other EU product law that may apply to the same product. Article 9 says that where a more specific Union harmonisation law wholly or partly covers risks addressed by Annex III EHSRs, the Machinery Regulation does not apply to that product to the extent the more specific law covers those risks. Article 21 also anticipates products subject to more than one Union legal act requiring an EU declaration of conformity and allows a single declaration covering all of them.

For LVD and RED, Article 2 expressly excludes specified electrical and electronic categories when they fall within Directive 2014/35/EU or Directive 2014/53/EU, including household appliances for domestic use that are not electrically operated furniture, audio and video equipment, information technology equipment, ordinary office machinery except additive printing machinery for producing three-dimensional products, low-voltage switchgear and control gear, and electric motors. For AI, Annex I Part A captures safety components and embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions; EU notified-body listings also identify the AI Act as active legislation. For EMC, the grounding material identifies Directive 2014/30/EU as EU harmonisation legislation, so electrical or electronic machinery projects should check EMC obligations separately when electromagnetic compatibility issues are present.

The general application date is 20 January 2027. Directive 2006/42/EC is repealed with effect from the same date. Products placed on the market in conformity with Directive 2006/42/EC before 20 January 2027 can continue to be made available on the market under the Article 52 transitional provision.

Several provisions apply earlier. Articles 26 to 42 on notification of conformity assessment bodies apply from 20 January 2024. Article 50(1) on Member State penalty rules applies from 20 October 2026. Article 6(7), Article 48, and Article 52 apply from 19 July 2023. Article 6(2) to (6), (8), and (11), plus Articles 47 and 53(3), apply from 20 July 2024.

For machinery and related products, Article 10 requires the manufacturer to draw up Annex IV Part A technical documentation, apply or have applied the relevant Article 25 conformity assessment procedure, draw up the EU declaration of conformity under Article 21 after conformity is demonstrated, and affix CE marking under Article 24. The manufacturer must keep the technical documentation and EU declaration of conformity available to market surveillance authorities for at least 10 years after the product is placed on the market or put into service.

Annex IV Part A technical documentation includes a complete product description and intended use, risk assessment, applicable EHSR list, protective measures and residual risks, drawings and explanations, applied harmonised standards or common specifications, other technical specifications where standards are not fully applied, test and inspection results, production conformity measures, instructions, relevant declarations for incorporated products, series-production controls, safety-related software material where requested, and specific material for sensor-fed, remotely driven, or autonomous machinery where appropriate.