Regulation (EU) 2023/1230 on machinery was adopted on 14 June 2023 and published on 29 June 2023. Its general application date is 20 January 2027, when Directive 2006/42/EC is repealed. Some provisions apply earlier. Manufacturers should distinguish entry into force from the date on which the main product obligations apply.
The Machinery Regulation provides directly applicable EU rules for machinery safety, reducing the need for national transposition. Its requirements address risks associated with software, connected machinery and systems with self-evolving behaviour. The relevant duties depend on the product, its intended use and the role of each economic operator.
Highlights
- A substantial modification has a defined meaning in Article 3(16). Under Article 18, a person carrying out such a modification generally takes on manufacturer obligations and must use the relevant conformity assessment procedure. A software update or physical alteration is not automatically a substantial modification: assess the change against the legal definition and document its effect on safety.
- Annex I distinguishes Part A and Part B categories for conformity assessment. Check the exact category and the relevant safety functions before selecting a procedure.
- Annex I Part A requires a procedure involving a notified body. Part B permits internal production control only where the relevant harmonised standards or common specifications cover all applicable essential health and safety requirements; otherwise a notified-body route is required.
- The safety-component definition includes qualifying digital components and software independently placed on the market (Article 3(3)).
- Digital instructions are permitted subject to Article 10(7), including access, download and retention requirements, a free paper copy on a request made at purchase, and essential paper safety information for non-professional users.
- Article 20 provides a presumption of conformity for the requirements covered by cited harmonised standards or applicable common specifications. It is not a blanket presumption covering every risk of a product.
Safety components
The new Machinery Regulation will address future updates or developments of software installed in machinery or related products during the risk assessment. These risks must include those that may arise during the product’s lifecycle due to an intended evolution of its behavior to operate with varying levels of autonomy.
Software that performs fixed automated functions is not thereby exempt from machinery safety obligations. Requirements specifically addressing self-evolving behaviour apply where that characteristic is relevant; the other applicable requirements still need to be assessed.
Software independently placed on the market falls within the safety-component rules when it meets Article 3(3). The supplier must address the applicable conformity assessment, technical documentation, EU declaration of conformity, marking and instruction obligations. Not every software application used with machinery is a safety component.
For the first time, the Machinery Regulation therefore applies to an immaterial product.
A safety component is a physical or digital component, including software, intended to fulfil a safety function and independently placed on the market. Its failure or malfunction can endanger safety, and it is not necessary for ordinary functioning or can be replaced by a normal component for that purpose. Apply the full definition in Article 3(3) to the product being supplied.
Instructions and sales literature
Article 10(7) permits digital instructions. They must identify the product model, be clear and understandable in the language required by the Member State, and remain usable when the machine cannot connect to a network. A user requesting a paper copy at purchase must receive it free of charge within one month. Essential safety information must still accompany machinery in paper form where non-professional use is intended or reasonably foreseeable.
When the instructions for use are provided in digital format, the manufacturer shall:
- mark on the machinery or related product, or, where that is not possible, on its packaging or in an accompanying document, how to access the digital instructions;
- present them in a format that makes it possible for the user to print and download the instructions for use and save them on an electronic device so that he or she can access them at all times, in particular during a breakdown of the machinery or related product;
- this requirement also applies when the machinery or related product’s software embeds the instructions for use.
- make them accessible online during the expected lifetime of the machinery or related product and for at least 10 years after the placing on the market of the machinery or related product.
Sales literature describing the machinery or related product shall not contradict the instructions for use as regards health and safety aspects.
Artificial Intelligence and machinery safety risk
Risk assessment must consider intended changes in the behaviour of systems with self-evolving functions. Annex III addresses the reliability of control systems, limits defined by the manufacturer and the prevention of hazardous behaviour. The appropriate safety architecture follows from the assessed risks; the Regulation does not prescribe one universal circuit design for all AI-enabled machinery.
Annex III also addresses autonomous mobile machinery, including supervision and safe movement. Automated guided vehicles and autonomous mobile robots used in warehouses or hospitals must be assessed against the requirements relevant to their actual functions and operating environment.
Where connections or access to hardware and software could compromise safety, Annex III requires protection against corruption. The assessment must consider accidental and intentional interference affecting safety-related systems. Connectivity does not make every machine identical, and the control measures must match the relevant risks.
Collaborative robots (cobots) require new safety solutions to ensure people’s safety in collaborative applications, including psychological stress. As a result, the Machinery Regulation modifies the safety and health requirement for risks arising from moving parts.
EU Declaration of Conformity
The Machinery Regulation uses an EU declaration of conformity, replacing the Directive’s EC declaration terminology. Where several applicable Union acts require such a declaration, Article 21 provides for a single EU declaration identifying the legislation concerned.
Machinery or related products presenting a higher risk factor
Annex I replaces the Directive’s Annex IV list for the purposes of the new conformity assessment framework. Part A includes certain safety components and machinery with self-evolving behaviour using machine-learning approaches to ensure safety functions. Part B has a different choice of procedures under Article 25.
For the six categories in Annex I Part A, Article 25(2) permits EU type-examination followed by conformity to type based on internal production control (modules B+C), full quality assurance (module H), or unit verification (module G). Each route involves a notified body; internal production control alone is not an available Part A route. The categories are:
- detachable mechanical transmission devices, including their guards;
- guards for detachable mechanical transmission devices;
- vehicle lifts;
- portable explosive-powered tools for fastening or other impact machines;
- safety components with totally or partially self-learning behavior using automatic learning approaches that guarantee safety functions;
- Machinery embedding systems with self-evolving behaviour using machine-learning approaches to ensure safety functions, where those systems have not been placed independently on the market, in respect of those systems.
One example is the inclusion of systems that ensure safety functions and have self-evolving behavior in Annex I due to their characteristics, such as data dependency, autonomy, opacity, and connectivity, which can significantly increase the likelihood and severity of harm and affect the machinery or related product’s safety.
Safety software marketed separately needs to comply.
However, if the machinery embeds a system where the safety component has already undergone third-party conformity assessment when independently placed on the market, the machinery should not require re-certification by a third party based only on the system’s embedding.
Transitional provisions
The general application date is 20 January 2027 (Article 54), following the July 2023 corrigendum. Directive 2006/42/EC is repealed from the same date (Article 51). Article 52 protects the continued making available of products lawfully placed on the market under the Directive before that date. Manufacturers should plan the applicable conformity assessment, technical documentation and declaration for the actual placing-on-the-market or putting-into-service event, rather than calculating a new date from an assumed transition period.
EC type-examination certificates and approval decisions issued in accordance with Article 12 of Directive 2006/42/EC shall remain valid until they expire
Outlook
AI, IoT, and robotics can pose risks to legally protected interests, despite their many opportunities. As their applications expand, the probability of such risks occurring will also increase. For small and medium-sized enterprises (SMEs) in the machinery sector, legal certainty is particularly crucial, as they often have limited resources to interpret legal texts.
Harmonised standards can support a presumption of conformity only for the requirements they cover and when their references are published in the Official Journal. Work from the applicable European standards and the Regulation itself; general international standardisation activity, including that of the International Organization for Standardization, does not itself establish EU conformity.
The main machinery obligations apply from 20 January 2027. Entry into force and the earlier application of selected administrative provisions are separate milestones.
For further information, the form below provides access to the earlier European Parliament legislative material. For present compliance planning, use the current consolidated Regulation and its linked authentic Official Journal acts, including the corrigendum, rather than treating the earlier proposal as the final law.
Technical references: Regulation (EU) 2023/1230, consolidated text, Articles 3, 10, 18, 20, 21, 25, 51, 52 and 54, and Annexes I and III (checked 1 October 2026).
