EU Machinery Regulation Applicability Test

Regulation (EU) 2023/1230 applies to machinery, five named related products, and partly completed machinery. The related products are interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices.

Do not stop at the product label. A product can be machinery even when it is missing only site connection components, must be installed on a vehicle, building, or structure before it functions, is an integrated assembly of machines controlled to achieve the same end, is manually powered lifting machinery, or is missing only the upload of software foreseen by the manufacturer.

A safety component can be physical or digital, including software. The test is whether the component is designed or intended to fulfil a safety function, is independently placed on the market, and its failure or malfunction endangers people while the machinery could otherwise function without it or with a normal substitute.

Annex II is useful as a non-exhaustive screen. It lists examples such as emergency stop devices, logic units for safety functions, protective devices, software ensuring safety functions, and safety components with fully or partly self-evolving machine-learning behaviour ensuring safety functions.

A substantial modification is not every repair, retrofit, or software update. Under Article 3, the modification must be physical or digital, occur after placing on the market or putting into service, be outside what the manufacturer foresaw or planned, affect safety by creating a new hazard or increasing an existing risk, and require new guards/protective devices that modify the safety control system or additional protective measures for stability or mechanical strength.

The Commission machinery page also keeps the same practical boundary from the Machinery Directive context: existing machinery can become de facto new machinery when modified to that extent. Use that as a warning sign, then apply the Regulation's definition.

Article 2 exclusions remove specific products from the Machinery Regulation scope. For connected or electrical products, the most common scoping check is the exclusion for named electrical and electronic products that fall within the Low Voltage Directive or Radio Equipment Directive, 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 3D products, low-voltage switchgear and control gear, and electric motors. High-voltage switchgear/control gear and transformers are also excluded.

Article 9 is the overlap rule for products that remain within the Regulation's scope. If a more specific EU harmonisation law covers a risk addressed by Annex III, the Machinery Regulation does not apply to that product to the extent that the more specific law covers that risk. The Regulation also states that LVD safety objectives apply to machinery or related products, while conformity assessment and market-placement obligations for electrical risks are governed solely by the Machinery Regulation.

For in-scope machinery and related products, Article 10 allows instructions for use in digital format if the machine or packaging explains how to access them, the user can print, download, and save them, and online access remains available for the expected lifetime and at least 10 years after placing on the market. Non-professional users still need essential safety information on paper, and paper instructions must be provided free of charge within one month when requested at purchase.

For partly completed machinery, Article 11 applies the same digital-access logic to assembly instructions and the EU declaration of incorporation. The transition point to track is 20 January 2027: the Regulation applies from that date, Directive 2006/42/EC is repealed from that date, and the Commission states that machinery placed on the EU market before then must comply with the current Machinery Directive.