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Like the Machinery Directive, the Machinery Regulation defines health and safety requirements for machinery placed on the market or put into service within the European Union.
The new regulation will replace the current 2006 Machinery Directive (transposed into French law in the Labor Code: Book III of the regulatory section) as of January 20, 2027.
It is not a directive, so no transposition into national law is required. This avoids delays and legal uncertainty for economic operators that could arise from "divergent implementation by Member States."
New technologies addressed
What is a machine?
Under the directive, a machine is defined, among other things, as an assembly of linked parts or components, at least one of which moves, joined together for a specific application.
The following are also considered machinery under the Machinery Directive:
- Assemblies of machinery or complex installations. Complex installations also include production lines, special machines composed of multiple machines, and interconnected machines.
- Safety components: Determining which components should be classified as safety components has been a subject of highly controversial discussion. The parties have not yet reached an agreement.
- Interchangeable equipment that modifies the basic functions of a machine.
- Partly completed machinery
Developments
To account for emerging new technologies (autonomous machines), the definition of "machinery or related product" has been expanded to include them (e.g., cobots, 3D printers, etc.).
There is also a list of exclusions (means of transport by air, water, and rail networks, with the exception of machinery mounted on these means of transport, motor vehicles and their trailers, etc.).
Substantial modifications
Already practiced in France, a Technical guide regarding modification operations for machinery or assemblies of machinery in service offers a definition of modification as well as examples.
The definition of a modification is based primarily on the existing instruction manual and its content. If work is performed on a machine that is not accompanied by a manual, it will be considered a modification. If the work changes the machine's intended use or involves installing parts not provided for in the manual, it is also considered a modification.
The procedure for a "substantial modification" of machinery is now integrated into the regulation. In short, this refers to a modification not foreseen by the manufacturer that affects the safety of the machine by "creating a new hazard or increasing an existing risk," which necessitates the addition of protective devices or additional protective measures to ensure the machine remains stable or that its mechanical integrity is not compromised. The current Machinery Directive does not address this situation.
In the event of a "substantial modification," the modifier becomes the manufacturer, with all the associated obligations (compiling technical documentation, performing conformity assessments, etc.).
Note: This does not apply to individuals modifying a machine for their own personal use. It applies to importers, distributors, and users.
Digital documentation
The regulation specifies that the instruction manual may be provided in digital format. Upon the customer's request, the manufacturer must provide the manual in paper format. The declaration of conformity may also be provided in digital format, while partly completed machinery may be supplied with a digital assembly manual and a digital declaration of incorporation.
Currently, the directive requires manufacturers to provide necessary information about machines, such as instruction manuals, in paper form.
Parties involved in the design or manufacture of machinery and related products
(Related products: interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices)
Today, the directive defines a manufacturer as any natural or legal person who designs and/or manufactures a machine, related product, or partly completed machinery for the purpose of placing it on the market or putting it into service under their own name or trademark, or for their own use (manufacturer or authorized representative).
The regulation extends the obligations incumbent upon the manufacturer to importers and distributors if they place a machine or related product on the market under their own name or trademark.
The terms "importer" and "distributor" are now officially recognized as market operators.
Updating the list of machinery subject to a conformity assessment procedure
Annex I replaces Annex IV (machinery and related products presenting a high inherent potential risk) and specifies the risk level of the machinery. The annex is therefore divided into Part A and Part B, depending on the risk level (List A corresponds to machinery with a higher risk).
List A:
- Vehicle servicing lifts,
- Removable mechanical transmission devices and their guards,
- Guards for removable mechanical transmission devices,
- Safety components that use machine learning approaches, either fully or partially,
- Portable cartridge-operated fixing and other impact machinery.
The machinery and related products on this list are subject to a conformity assessment by a notified body, regardless of whether they are manufactured in accordance with a harmonized standard.
For machinery or related products on list B, manufacturers may continue to declare conformity without involving a notified body, provided they apply harmonized European standards that cover all relevant risks.
Note: The manufacturer must comply with EHSRs (Essential Health and Safety Requirements). Harmonized standards specify the means to achieve these performance obligations. Compliance with them exempts the manufacturer from third-party conformity certification.
Other developments…
To address cybersecurity challenges (risks resulting from malicious third-party actions impacting machine safety), a new section has been added to the EHSRs (Essential Health and Safety Requirements).
To address the issue of autonomous machines and artificial intelligence, the EHSR sections related to human-machine interaction—specifically those concerning ergonomics and risks associated with moving parts and psychological stress—have been revised.
The European Commission will be able to update the regulation for high-risk machinery more easily. It will be able to act on its own initiative or at the request of other parties to add or remove machinery from the list.
The definition of safety components now includes software, in addition to physical, digital, and/or hybrid components.
Mobile machinery is covered in a virtually new section of Annex III.
The declaration of conformity and the declaration of incorporation for partly completed machinery are now EU declarations, rather than EC declarations.
In summary
The new regulation harmonizes the essential health and safety requirements applicable to machinery in the EU, facilitates the free movement of machinery, and ensures a high level of safety for workers and citizens.
Key fundamental points regarding artificial intelligence as it relates to machinery are included in the Machinery Regulation. Nevertheless, an Artificial Intelligence Regulation is also planned.
Photo credit: 609841105 @Westend61