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Which requirements of the Machinery Regulation actually apply to my machine – and how can I provide clear documentation to show that these requirements were taken into account during the design and risk assessment phases?
With the Machinery Regulation (EU) 2023/1230, this question has become even more central. The essential health and safety requirements will in future be set out in Annex III of the Regulation. Manufacturers must identify which of these requirements apply to their machine and ensure that they are met during the design and construction phases.
It is not enough simply to go through Annex III as a checklist at the end of a project. The legal requirements and the risk assessment are intrinsically linked: the risk assessment identifies relevant hazards and hazardous situations – from which, in turn, it can be determined which requirements from Annex III must be taken into account and what measures are needed to implement them.
Safexpert 10 supports this process with a structured list of requirements. The requirements set out in Annex III can be checked for applicability and directly linked to the corresponding measures identified in the risk assessment. This creates a clear link between the legal requirement and its technical implementation.
Not every requirement applies to every machine.
Which requirements apply depends in particular on the characteristics of the machine and its risk assessment.
Nevertheless, Annex III must be considered in its entirety.
Only in this way can a transparent decision be made as to which requirements are applicable or inapplicable.
The risk assessment and the list of requirements should be linked.
Ideally, it should be possible to trace which specific measure was used to implement a statutory requirement.
The Machinery Regulation (EU) 2023/1230 will apply from 20 January 2027 and replaces the Machinery Directive 2006/42/EC. What many designers recognise under the Machinery Directive as the essential health and safety requirements set out in Annex I is now contained in Annex III of the Machinery Regulation. Annex III is entitled: ‘Essential health and safety requirements relating to the design and construction of machinery or related products.’
Until 19 January 2027
Machinery Directive 2006/42/EC
Annex I
Essential health and safety requirements
From 20 January 2027
Machinery Regulation (EU) 2023/1230
Annex III
Essential Health and Safety Requirements
These requirements form a key basis for safe design. They cover topics such as:
In addition, Annex III contains requirements for specific types of machinery and particular hazards. For a machinery manufacturer, the crucial question is therefore: Which of these requirements are relevant to my specific machine, and how do I demonstrate compliance with them? Not every requirement in Annex III applies to every machine. Annex III contains a large number of different requirements. However, this does not mean that every single requirement is equally relevant to every machine. In principle, a requirement must be taken into account if the corresponding hazard or situation could arise in the machine in question. For example, a machine without relevant thermal hazards requires different requirements to be considered than a machine with very hot surfaces. A stationary machine tool, in turn, gives rise to different requirements than a mobile machine or a machine designed to lift persons. This is precisely why the risk assessment is the starting point for determining the applicable requirements. The Machinery Regulation expressly requires the manufacturer to carry out a risk assessment to establish which essential health and safety requirements apply to the machine.This means: do not first build the entire machine and then simply tick off Annex III. Instead: identify risks → determine relevant requirements → define suitable measures → demonstrate implementation.
Nevertheless, Annex III must be examined in full. The fact that not every requirement is applicable does not mean that manufacturers should only consider the obviously relevant sections. The Machinery Regulation expressly states that Annex III must be considered in its entirety to ensure that no relevant requirements are overlooked. This is an important distinction. A requirement may ultimately be assessed, for example, as applicable or not applicable.
However, in order to make such a decision, it must first have been assessed whether the requirement in question is relevant to the specific machine. A structured list of requirements can help precisely with this: it does not force one to artificially apply every requirement to a machine. Rather, it helps to ensure that no requirement is inadvertently overlooked.
In practice, risk assessments and lists of statutory requirements are sometimes documented separately. This can quickly lead to duplication of documentation work.
However, it is not only crucial to record that a requirement has been met, but also to document in a traceable manner the specific protective measure by which it is implemented.
Document 1: Risk assessment in accordance with EN ISO 12100
Document 2: Checklist for the Machinery Regulation
The link between the requirement and the specific protective measure is not immediately apparent.
Requirement from Annex III
↓ Hazardous situation
↓ Specific protective measure
→ verifiable evidence
Clear and comprehensible documentation links the legal requirement directly to the hazard and the protective measures derived from it.
A measure may fulfil several requirements. The relationship between requirements and measures is not necessarily one-to-one. A single technical measure may support several essential requirements. Conversely, fulfilling a single statutory requirement may require several technical measures.
It is only through the interaction of these measures that the safety-related task is fully fulfilled. Good documentation should be able to illustrate such interrelationships without having to record identical measures repeatedly for every statutory requirement.
A practical example: access to an automated machine areaAn automated assembly line has several moving axes and a robot. The example of access to the automated work area clearly illustrates the link between risk assessment and Annex III.
Identifying hazards
A person may enter the machine’s operating area and be caught or crushed by dangerous movements.
Assess the risk
The severity of potential harm and the likelihood of its occurrence are assessed. Risk reduction is required.
Define measures
For example, protective barriers, an interlocked access door, safe shutdown and protection against unexpected restart.
Refer to Annex III
The relevant requirements from Annex III are linked to the protective measures implemented.
The designer therefore does not document the same information twice, but links the information already compiled as part of the risk assessment to the statutory requirement.
In principle, a list of requirements can, of course, also be managed in Excel or another document. For small projects, this may seem sufficient at first. However, as complexity increases, certain typical questions arise:
Typical questions regarding separate documentation
Could this also affect the documentation of a requirement? If risk assessment, standards management and the list of requirements are kept in separate files, links between them often have to be maintained manually. This is precisely where an integrated approach can offer advantages.
Safexpert supports manufacturers in systematically addressing the essential health and safety requirements using its own list of requirements. The following is already included in the scope of delivery:
‘List of Requirements for the Machinery Regulation (EU) 2023/1230, Annex III’
It contains the requirements from Annex III and can be used within a CE project. For each requirement, it is possible to systematically check whether it is relevant to the product in question. This provides a structured overview of
Justify applicability rather than simply ticking boxes. A transparent assessment is particularly important when dealing with extensive lists of legal requirements. The statement ‘not applicable’ may well be entirely correct. However, it is crucial that this decision was reached in a technically sound manner. In Safexpert, decisions on applicability can be supplemented with comments. This allows you, for example, to document: ‘Requirement not applicable, as the machine does not present a corresponding hazard or possess the relevant function.’ Such justifications can be particularly helpful during subsequent internal audits. This is because, months or years after a project has been completed, it may no longer be obvious why a particular requirement was excluded at the time.
Linking requirements directly to risk assessment measures
The list of requirements becomes particularly useful when linked to the risk assessment. In Safexpert 10, requirements from the list can be assigned directly to a risk assessment measure via drag-and-drop.
This documents, for example, that the requirement set out in Annex III is met by Measure A + Measure B + Measure C.
The key advantage is that the measure does not need to be described separately again in a regulatory checklist. The technical solution already documented as part of the risk assessment is linked to the corresponding regulatory requirement. This creates a consistent documentation structure.
A well-structured workflow integrates the risk assessment, the list of applicable legal requirements and the technical documentation into a single, consistent process.
In this way, risk assessment and the verification of legal requirements do not become two separate tasks, but rather a single, integrated process.
When it comes to technical documentation, the key question is: Which requirements apply to this specific machine? Safexpert therefore allows the requirements necessary for the product to be generated as a report within the CE Guide. This enables a project-specific list to be created.
Instead of a general list of all the requirements set out in Annex III, an overview is produced of those requirements that are relevant to the product in question. This is particularly helpful for technical documentation and internal reviews.
The major advantage is that regulatory requirements become an integral part of the design process. A list of requirements is often only completed shortly before the completion of a CE project. There is then a risk that it will be viewed merely as a formality:
Tick the boxes → save the document → done.
It makes far more sense to incorporate the requirements into the design process at an early stage. This allows questions to arise, for example, as early as the risk assessment stage, such as:
The list of statutory requirements thus evolves from a retrospective checklist into an active component of safe design. The list of requirements is no substitute for professional judgement. Even software cannot relieve the manufacturer of their professional responsibility. A fully completed list of requirements does not automatically prove that a machine is safe or compliant with the law. Among other things, the following remains crucial:
The checklist helps to link these findings to the statutory requirements in a structured manner. It is therefore a tool for ensuring a transparent process – not a substitute for technical expertise.
The following questions can serve as a guide for each machine:
Not every requirement needs to apply – but every potentially relevant requirement should be considered.
The decision should be based on the characteristics and risk assessment of the machine.
Where necessary, this decision should be documented in a way that is clear and traceable.
This is where the link to risk assessment comes in.
It should be clarified which requirements are actually covered by the relevant standards.
Such outstanding issues should be identified as early as possible in the project.
The list of applicable requirements and the corresponding protective measures form part of the documented evidence of the CE process.
Annex III of the Machinery Regulation is far more than just a checklist to be ticked off shortly before a project is completed. The essential health and safety requirements, together with the risk assessment, form a central basis for the safe design of a machine. Manufacturers must systematically determine which requirements apply to their machine, how these requirements are technically implemented, and how compliance with them can be documented in a verifiable manner.
It is particularly useful to establish a direct link between the requirements set out in Annex III and the specific measures identified in the risk assessment.
Safexpert 10 supports this process with the list of requirements for the Machinery Regulation (EU) 2023/1230. The applicability of the requirements can be systematically checked and documented. Requirements can be directly linked to the measures identified in the risk assessment, and the requirements relevant to the specific product can be output as a report.
This transforms an abstract legal requirement into a clear chain:
Requirement → Hazardous situation → Protective measure → Evidence.
This is precisely where the real benefit of a structured list of requirements lies: ensuring that no relevant requirements are overlooked, whilst at the same time transparently documenting how they have been implemented in the specific machine.
Product note
Safexpert 10 – Risk assessment has never been so intuitive
In Version 10, you can perform risk assessments easily, quickly and in compliance with standards. A completely new user interface allows you to navigate intuitively and in a legally compliant manner through all processes.
More information
Posted on: 31 July 2026
Head of Marketing at IBF. Degree in Business Sciences from the SoWi Innsbruck. Over 10 years of experience in the B2B sector, with a focus on mechanical and automotive engineering, electronics development/production and software development.
E-Mail: daniel.magnus@ibf-solutions.com | www.ibf-solutions.com
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