Last edit: 21/04/2026
THE DOUBT: In an ideal scenario, machinery and production lines are engineered, manufactured, installed, commissioned, and ultimately CE marked by a single manufacturer. Whenever modifications are required, the employer would rely on the original manufacturer to carry them out, ensuring that the original CE marking remains valid.
In reality, however, CE-marked production lines are often subject to multiple modifications over time, performed by different parties. As a result, the original manufacturer would rarely consider the initial CE marking still valid. This creates a critical issue: the employer may no longer be able to use the machinery, as it is no longer CE compliant—in other words, its safety can no longer be guaranteed. A similarly common situation arises when a production line consists of multiple machines or partly completed machinery; in such cases, someone must assume responsibility as the “manufacturer” of the complete line. This role may be taken on by one of the suppliers, but more often it falls to the employer.
To address this, a prudent employer—or a diligent new Production Director—may engage a trusted consultancy firm to perform a comprehensive risk assessment. The aim is to identify potential hazards affecting operators and maintenance personnel. This assessment can be carried out in accordance with relevant standards, including C-type standards as well as B-type standards such as EN 60204-1 and EN IEC 62061. Based on the findings, additional safeguards—such as guards or protective devices—may be implemented, often with the support of specialized external contractors.
At the end of this process, the production line could be considered safe, and the employer may decide to affix the CE marking. This decision is often driven by the practical reality that no external manufacturer is willing to assume responsibility for CE marking a production line they did not design and build.
This leads to a fundamental question: does the employer have the legal right to do so? And if so, is this CE marking to be considered valid—or is it fake?
1° CONSIDERATION: The domain of the Machinery Directive 2006/42/EC is particularly fascinating because, unlike mathematics, it does not always provide absolute clarity. Certain aspects are not explicitly defined and are therefore open to interpretation.
One such interpretation argues that a CE marking affixed by the employer is invalid, on the basis that only a “manufacturer” is entitled to CE mark machinery or a production line. According to this view, since the employer did not originally manufacture the production line — or the machinery that has subsequently been modified — the CE marking bearing the employer’s name would be considered illegitimate.
2° CONSIDERATION: We disagree with that position. Hereafter our point of view. The machinery directive gives the following definition of manufacturer.
[Directive 2006/42/EC] – Article 2 – Definitions
(i) ‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;
From that definition, we understand that a manufacturer shall not necessary have physically engineered, manufactured, installed and commissioned the product.
The official guide to the machinery directive helps us further.
[MD Guide Edition 2.3] – §79 Who is the manufacturer?
A manufacturer can be a natural or legal person, that is to say, an individual or a legal entity such as a company or association. The process of design and construction of machinery or partly completed machinery may involve several individuals or companies, but in this case one of them must take the responsibility, as the manufacturer, for the conformity of the machinery or partly completed machinery with the Directive. However, the term manufacturer in this Directive also can apply to other persons who have the responsibilities for conformity assessment and CE marking – see §81: comments on Article 2 (i).
At the end of the same paragraph, the following language is used:
[MD Guide Edition 2.3] – §79 Who is the manufacturer?
[…] Usually, the elements constituting an assembly of machinery are supplied by different manufacturers, however one person must assume the responsibility for the conformity of the assembly as a whole. This responsibility can be assumed by the manufacturer of one or more of the constituent units, by a contractor or by the user. If a user constitutes an assembly of machinery for his own use he is considered as the manufacturer of the assembly.
From all of the above, for us, it is clear that the person who CE Marks a machinery, or a production line, shall not necessary have a development, engineering and production department. In the case of a user (employer), he has none of the previous entities and he is still allowed to CE mark the line.
Our conclusion, therefore, is that an employer can CE mark a production line installed by different manufacturers. He can also CE mark a production line modified in order to improve its safety.
However he has to follow the obligations stated in Article 5 of the Machinery Directive!
[Directive 2006/42/EC] Article 5 – Placing on the market and putting into service
1. Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:
- ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;
- ensure that the technical file referred to in Annex VII, part A is available;
- provide, in particular, the necessary information, such as instructions;
- carry out the appropriate procedures for assessing conformity in accordance with Article 12;
- draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;
- affix the CE marking in accordance with Article 16.
In other terms, before the CE marking, the user has to do a thorough risk assessment, for which he needs competences, that do not belong to the original manufacturer only.
[MD Guide Edition 2.3] – §105 Means of ensuring the conformity of machinery?
[…] The means may include, for example, access to the necessary qualified personnel who have knowledge of both the Machinery Directive and relevant standards, access to the necessary information, the competency and the equipment needed to carry out the necessary design checks, calculations, measurements, functional tests, strength tests, visual inspections and checks on information and instructions to ensure the conformity of the machinery with the relevant essential health and safety requirements. When machinery is designed and constructed according to harmonised standards, the standards normally specify the means to be used to verify the conformity of the machinery with their specifications . Access to the relevant standards is required in this case.
3° CONSIDERATION: The New Machinery Product Regulation confirms that approach by giving a different definition of Manufacturer, in line with the definitinìon that has always been in the Blue Guide.
[Machinery Product Regulation – May 2023] – Article 3 – Definitions
(18) ‘manufacturer’ means any natural or legal person who:
(a) manufactures products within the scope of this Regulation or who has those products designed or manufactured, and markets those products under its name or trademark;
or
(b) manufactures products within the scope of this Regulation, and puts those products into service for its own use;
That definitionis now in line with what is stated in the Blue Guide.
[Blue Guide – 2022] – 3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS
3.1. Manufacturer
— The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark.
CONCLUSION: An employer, or end user, can affix the CE marking to machinery or a production line, provided they effectively assume the role of “manufacturer” as defined under the Machinery Directive 2006/42/EC. This requires possessing—or engaging—adequate technical competence to carry out a thorough and well-documented risk assessment, relying as far as possible on the relevant harmonised standards supporting the Directive.
Where such a comprehensive assessment is properly conducted, and all applicable essential health and safety requirements are demonstrably fulfilled, the EU Declaration of Conformity signed by the employer is both valid and legally binding.
Conversely, if the analysis is superficial or incomplete, and the Declaration of Conformity is issued without sufficient technical justification, the resulting CE marking cannot be considered legitimate. In such cases, the declaration would lack legal validity and could be regarded as merely nominal.