Directives and Regulations
Partly Completed Machinery and the New Machinery Regulation: What Changes in 2027?
Regulation (EU) 2023/1230 retains the definition of partly completed machinery while introducing more explicit requirements for documentation, instructions, traceability and the supply chain.
For years, partly completed machinery has mainly been defined by what it is not: it is not yet machinery, it cannot in itself perform a specific application and it must be incorporated into a larger assembly.
Regulation (EU) 2023/1230 does not change this approach. It does, however, change the regulatory weight of the information supplied with partly completed machinery.
For projects spanning 2027, the decisive issue remains which legal regime applies when the product is placed on the market, as examined in Machinery delivered in 2027: Directive or Regulation?.
From 20 January 2027, it will be much harder to treat partly completed machinery as an industrial component accompanied only by a declaration of incorporation and a few assembly notes. The technical documentation becomes more structured, the assembly instructions must contain much more precise information, and the obligations expressly involve importers and distributors as well.
The definition of partly completed machinery remains the same
The definition in the new Regulation is substantially continuous with that in Directive 2006/42/EC.
Partly completed machinery is an assembly that is not yet machinery because it cannot in itself perform a specific application and is intended only to be incorporated into or assembled with machinery, other partly completed machinery or equipment, thereby forming machinery.
The decisive point is therefore whether the product can perform a specific application in its own right.
A product does not automatically become partly completed machinery merely because a guard, certain safety devices or the final documentation are missing. If it is already capable of performing its specific application by itself, its classification must be assessed very carefully. Describing the product as “partly completed machinery” cannot be a way of postponing the conformity assessment until it reaches the recipient.
The classification depends on the product’s actual function, configuration and intended purpose, not on the name used in the commercial offer.
The new Regulation does not introduce CE marking for partly completed machinery under machinery legislation. The relevant document remains the declaration of incorporation, which from 2027 will become the EU declaration of incorporation. Other Union acts applicable to the product may, of course, impose different obligations and must be assessed separately.
Reference: Regulation (EU) 2023/1230, Article 3(10).
The real change is the position of partly completed machinery
Directive 2006/42/EC deals with partly completed machinery mainly in Article 13. Before placing it on the market, the manufacturer must prepare the relevant technical documentation, the assembly instructions and the declaration of incorporation.
The Regulation retains these three elements but places them within a much broader framework.
Article 8 directly provides that partly completed machinery may be made available on the market only if it meets the relevant essential health and safety requirements. Article 11 then builds a structured set of manufacturer obligations around that principle: product identification, traceability, retention of documentation, control of series production, corrective action and cooperation with the authorities.
Partly completed machinery is therefore treated more explicitly as a product in the supply chain whose conformity must be verifiable, whose manufacturer must be identifiable and whose technical decisions must be reconstructable.
The main differences
| Subject | Directive 2006/42/EC | Regulation (EU) 2023/1230 | Practical consequence |
|---|---|---|---|
| Placing on the market | Procedure concentrated in Article 13 | Compliance with the applicable requirements is an express condition for making the product available on the market | The conformity of partly completed machinery becomes more autonomous and visible |
| Technical documentation | Relevant technical documentation required by Annex VII, Part B | More detailed technical documentation under Annex IV, Part B | Risk assessment, verification and design decisions must be reconstructable |
| Assembly instructions | General content defined by Annex VI | Detailed content specified in Annex XI | Basic connection and assembly information is no longer sufficient |
| Declaration | EC declaration of incorporation | EU declaration of incorporation, which may also be made available digitally | Templates, references and publication systems must be updated |
| Identification | Less detailed obligations in the text of the Directive | Designation, year of construction, model, series and available product identifier on the product or in accompanying documents | The link between the product and its documentation must be unambiguous |
| Series production | Principle managed mainly through the manufacturer’s system | Express obligation to ensure that series production remains in conformity | Changes to design and production must be controlled |
| Supply chain | Rules centred on the manufacturer or authorised representative | Specific obligations also apply to importers and distributors | Documentation must be checked before the product is marketed |
| Non-conformity | Less explicit framework for partly completed machinery | Corrective action, withdrawal, recall and information to the authorities | Non-conformity cannot simply be transferred to the integrator |
The comparison is based in particular on Article 13 and Annexes II, VI and VII to Directive 2006/42/EC, and on Articles 8, 11, 14 and 16 and Annexes IV, V and XI to Regulation (EU) 2023/1230.
The technical documentation becomes more complete
Technical documentation for partly completed machinery is not introduced by the new Regulation. The Directive already requires documentation covering the risk assessment, the requirements applied, drawings, calculations, tests and the measures adopted.
Annex IV, Part B to the new Regulation defines its content more precisely.
The documentation must fully describe the partly completed machinery and its intended function after incorporation. It must identify the applicable essential health and safety requirements, the measures adopted to eliminate hazards or reduce risks, and any residual risks. It must also contain references to the harmonised standards, common specifications and other technical specifications actually used.
Where a standard is applied only in part, the documentation must identify the parts applied. A simple list of standards on a cover sheet is not sufficient to demonstrate how the hazardous conditions have been addressed.
The Regulation also addresses matters that could not have had the same relevance in 2006: the source code or programming logic of safety-related software, where required by the authorities to verify conformity, and information concerning sensor-controlled or autonomous systems that affect safety functions.
This material does not have to be supplied to the customer as a matter of course. It must, however, exist, be controlled and be capable of being made available to the competent authority following a reasoned request.
The change is therefore not simply a matter of adding documents to a technical file. It is about making the relationship between the risk assessment, the applicable requirements, the solutions adopted and the verification performed demonstrable.
Reference: Regulation (EU) 2023/1230, Annex IV, Part B.
Changes to the assembly instructions
This is probably the most tangible difference for those who design and supply partly completed machinery.
Annex VI to the Directive requires the instructions to describe the conditions to be met for correct incorporation without compromising health and safety. The principle is clear, but the required content remains fairly general.
Annex XI to the new Regulation goes into considerably more detail.
The instructions must explain how to incorporate, connect, adjust, maintain and verify the partly completed machinery. They must consider reasonably foreseeable misuse, stability, transport, handling, assembly and dismantling, the action to be taken in the event of a breakdown or blockage, and the information required for maintenance activities.
They must also provide the information needed to draw up the instructions for the final machinery.
This is an important change. Assembly instructions do not merely explain where to drill holes or how to connect a plug. They must transfer to the integrator the technical conditions and limits needed to produce safe final machinery.
If a safety function depends on how the partly completed machinery is connected, parameterised or coordinated with the rest of the installation, that dependency must be made clear.
The declaration may be digital, but it must remain traceable
The manufacturer must draw up the EU declaration of incorporation set out in Annex V, Part B. Among other information, the declaration must identify which essential health and safety requirements in Annex III have been applied and fulfilled and confirm that the relevant technical documentation has been drawn up.
The Regulation allows the manufacturer either to accompany the partly completed machinery with the declaration or to provide, in the assembly instructions, an internet address or machine-readable code through which it can be accessed.
Where the digital option is chosen, the link must remain accessible online for at least ten years after the partly completed machinery has been placed on the market. Digital assembly instructions must also be capable of being downloaded, printed and saved by the integrator.
Digital publication cannot therefore rely on a temporary link, a commercial folder or a page that will disappear at the next website update. Stable addresses, controlled versions and an unambiguous association between the document and the product are required.
Reference: Regulation (EU) 2023/1230, Article 11(7) and (8).
Importers and distributors expressly enter the chain
One of the most significant changes lies outside the technical annexes. Articles 14 and 16 introduce specific and distinct obligations for importers and distributors of partly completed machinery. Before placing it on the market, an importer must ensure that the manufacturer has drawn up the technical documentation and the EU declaration of incorporation and has fulfilled the other applicable obligations. Before making it available on the market, a distributor must verify, in particular, that the product is accompanied by the EU declaration of incorporation and the assembly instructions and bears the information needed to identify the product, the manufacturer and the importer.
Where there is reason to believe that the partly completed machinery is not in conformity, it must not be marketed until it has been brought into conformity. Where it presents a risk, the obligations to inform and cooperate with the market surveillance authorities also apply.
This will have particularly significant consequences for partly completed machinery coming from outside the European Union.
An importer will not be able to limit its checks to receiving a formally correct declaration. It must ensure that the manufacturer has drawn up the required technical documentation and that the product is accompanied by the information required by the Regulation.
The integrator must assess the requirements that remain to be fulfilled in the final machinery
The EU declaration of incorporation does not turn partly completed machinery into compliant machinery ready for use. It only states which requirements have been applied and fulfilled in the configuration supplied. Responsibility for the final machinery remains with the party that builds it and places it on the market or puts it into service.
That party must also assess the risks arising from incorporation: interactions with other elements, controls, stopping functions, safety distances, access points, the performance of safety functions and the use of the complete assembly.
The distinction is essential: the manufacturer of partly completed machinery cannot transfer to the integrator risks that should have been addressed on its own product. In turn, the integrator cannot assume that the risks of the final machinery have been resolved merely because the individual elements are accompanied by their respective declarations.
What sales contracts need to cover
Many documentation problems arise when the partly completed machinery has already been built and information is requested shortly before delivery. Under the new Regulation, the technical definition of the supply will have to be more precise from the order stage. The intended function, limits of use, interfaces, requirements applied, tests, information on safety functions and the content of the instructions cannot be clarified only at the end of the project.
For the manufacturer, this means updating templates and internal procedures; for the integrator, specifying before purchase which information is needed to assess the final machinery.
For importers and distributors, it means organising a genuine documentation check rather than merely verifying the presence of a PDF named “Declaration”.
Frequently asked questions
Will partly completed machinery require CE marking from 2027?
Not under the Machinery Regulation. It will continue to be accompanied by the EU declaration of incorporation and the assembly instructions. The possible application of other Union acts requiring CE marking must still be assessed separately.
May the EU declaration of incorporation be supplied only in digital form?
Yes. The manufacturer may provide in the assembly instructions an internet address or machine-readable code through which the declaration can be accessed. The document must remain accessible online for at least ten years after the product has been placed on the market.
Is a correct declaration of incorporation sufficient to integrate partly completed machinery?
No. The declaration identifies the requirements applied and fulfilled by the manufacturer, but the integrator must assess the incorporation, the interactions and the risks of the final machinery.
Preparing for 2027 means starting from the interfaces
The Regulation does not turn partly completed machinery into complete machinery. It does, however, change the level of precision with which its boundaries, conditions of incorporation and responsibilities along the supply chain must be defined.
Preparing for the change is not simply a matter of replacing “EC” with “EU” in the declaration template.
It is necessary to verify how the product is classified, which requirements are actually applied, which information reaches the integrator and whether the documentation makes the decisions taken demonstrable.
Partly completed machinery is, by definition, something that still has to be completed. From 2027, however, its documentation can no longer be incomplete as well.
