Technical Documentation for Machinery - Requirements under the Machinery Directive and Machinery Regulation
Technical Documentation for Machinery - Requirements Under the Machinery Directive and Machinery Regulation
What technical documentation is actually required to CE mark a machine?
It is not enough to simply perform a risk assessment, draft an instruction manual, and affix the CE mark to the machine. The manufacturer must also be able to demonstrate how the machine complies with the applicable essential health and safety requirements.
This is where the technical documentation comes in.
The requirements are set out in Machinery Directive 2006/42/EC, Annex VII, and in Machinery Regulation (EU) 2023/1230, Annex IV.
Much remains familiar, but when the Machinery Regulation becomes fully applicable on 20 January 2027, certain documentation requirements will become clearer, and new explicit provisions will be introduced.
What is Technical Documentation for Machinery?
Technical documentation comprises the technical file that makes it possible to assess whether machinery complies with the applicable essential health and safety requirements.
Among other things, it describes the machinery's design, operation, risk assessment, protective measures, and the calculations or test results required to demonstrate conformity.
This does not mean that every machine requires the exact same volume of documentation. The scope of the technical file depends on the machinery, its design, and the applicable requirements.
The essential point is that the documentation demonstrates how the requirements have been fulfilled.
What Must Technical Documentation Contain?
Annex VII A of the Machinery Directive specifies what the technical construction file must comprise. Annex IV A of the Machinery Regulation contains corresponding provisions for machinery and related products.
Here is a practical overview of the contents.
1. Description and Drawings
The documentation must comprise:
A general description of the machinery in accordance with the Machinery Directive.
An overall drawing of the machinery and drawings of the control circuits, as well as the relevant descriptions and explanations necessary to understand the operation of the machinery.
Full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to verify the conformity of the machinery with the safety requirements.
What changes with the Machinery Regulation?
Annex IV A explicitly specifies that the documentation must contain a complete description of the machinery or related product and of its intended use.
It also establishes requirements for design and manufacturing drawings and schemes of the machinery, its components, sub-assemblies, and circuits, accompanied by the relevant descriptions and explanations.
2. Risk Assessment and Safety Requirements
Both the Machinery Directive and the Machinery Regulation mandate documentation of the risk assessment.
Pursuant to Annex VII A of the Machinery Directive, the documentation must show the procedure followed, including:
A list of the essential health and safety requirements that apply to the machinery.
A description of the protective measures implemented to eliminate identified hazards or reduce risks.
Where appropriate, an indication of the residual risks.
Annex IV A of the Machinery Regulation sets out corresponding fundamental documentation requirements, but links the protective measures more explicitly to each of the applicable essential health and safety requirements.
EN ISO 12100 sets out the principles and methodology for risk assessment and risk reduction for machinery. There is no general legal obligation to use ISO 12100 specifically, but the risk assessment must satisfy the applicable legal requirements.
Read more in our article on machinery risk assessment in five steps.
3. Standards and Technical Specifications
Under the Machinery Directive, the documentation must specify the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards.
What changes with the Machinery Regulation?
Annex IV A provides more explicit provisions concerning:
References to the harmonised standards or common specifications applied.
Which parts have been applied, in the event of partial application.
Other technical specifications applied to meet each applicable essential health and safety requirement, where harmonised standards or common specifications have not been applied or only partially applied.
It is therefore no longer sufficient to merely cite a standard number. The technical documentation must provide the application details required by the respective legislation.
4. Calculations, Testing, and Verifications
The technical documentation must contain relevant technical files demonstrating that the machinery conforms to the applicable safety requirements.
Under the Machinery Directive, this includes:
Necessary calculations, test results, and certificates.
Technical reports giving the results of tests carried out by the manufacturer or by a competent body.
Results of the research and tests required to establish that the machinery can be assembled and put into service safely.
The Machinery Regulation explicitly specifies reports on and/or the results of design calculations, tests, inspections, and examinations carried out to verify conformity.
This is not an entirely new area of documentation. Requirements for relevant calculation notes and test results are already established in the Machinery Directive.
5. Instructions and Declarations
Annex VII A of the Machinery Directive requires the technical construction file to contain:
A copy of the instructions for the machinery.
Where appropriate, the declaration of incorporation and the relevant assembly instructions for partly completed machinery.
Where appropriate, copies of the EC declaration of conformity for incorporated machinery or other products.
A copy of the machine's own EC declaration of conformity.
Annex IV A of the Machinery Regulation requires, among other items, a copy of the instructions and the information set out in section 1.7.4 of Annex III.
It also requires, where applicable, the EU declaration of incorporation and assembly instructions for incorporated partly completed machinery, as well as copies of the EU declarations of conformity for incorporated products as referred to in Annex IV A (k).
A notable distinction is that Annex IV A of the Machinery Regulation does not contain a separate clause explicitly requiring a copy of the machine's own EU declaration of conformity within the technical file in the same way as Annex VII A of the Machinery Directive.
However, the manufacturer must draw up the EU declaration of conformity and be able to present it in accordance with Article 10.
6. Manufacturing and Series Production
For series manufacture, the Machinery Directive requires documentation of the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive.
Annex IV A of the Machinery Regulation sets out corresponding requirements for series-manufactured machinery and related products.
In addition, the Machinery Regulation explicitly specifies that the documentation must include a description of the means used by the manufacturer during production to ensure conformity with the design specifications.
Pursuant to Article 10(4), the manufacturer must also ensure that procedures are in place to ensure that series production remains in conformity. Adequate account must be taken of changes in design, production processes, and relevant standards or specifications.
What Changes with the Machinery Regulation in 2027?
The Machinery Regulation does not mean that the technical documentation process starts from scratch.
Most core areas of documentation are already established in the Machinery Directive. However, several requirements are more explicitly detailed, and certain new provisions are introduced.
Area | Change |
|---|---|
Machinery description | A complete description and intended use are explicitly mandated. |
Risk assessment | Protective measures must be described in relation to each applicable essential health and safety requirement. |
Standards | Partially applied harmonised standards and common specifications must be documented under the new provisions. |
Manufacturing methods | Explicit requirement for a description of the means used to ensure conformity with design specifications. |
Safety-related software | New explicit provisions regarding source code or programming logic upon reasoned request from authorities. |
Sensor-guided and autonomous systems | New explicit documentation requirements under specified conditions. |
Retention period | The triggering point for the ten-year retention period changes. |
Is Source Code Documentation Required Under the Machinery Regulation?
Annex IV A (m) and Article 10(3) of the Machinery Regulation contain provisions regarding the source code or programming logic of safety-related software.
Under the specified conditions, such information must be made available to a competent national authority upon a reasoned request, where necessary for the purpose of demonstrating conformity with the essential health and safety requirements.
This does not mean that the manufacturer is generally required to hand over all program code to the customer or make it public.
Corresponding provisions apply to partly completed machinery.
What Applies to Sensor-Guided and Autonomous Machinery?
Annex IV A (n) of the Machinery Regulation introduces a specific documentation requirement for sensor-fed, remotely-driven, or autonomous machinery and related products where safety-related operations are controlled by sensor data.
In such cases, the documentation must include, where applicable, a description of:
The general characteristics of the system.
The capabilities and limitations of the system.
The data, development, testing, and validation processes used.
This is not a general requirement for identical documentation across every machine incorporating a sensor.
What Documentation is Required for Partly Completed Machinery?
Partly completed machinery is subject to specific documentation requirements.
Under the Machinery Directive, these requirements are set out in Annex VII B. Under the Machinery Regulation, they are found in Annex IV B, alongside the manufacturer obligations under Article 11.
The documentation comprises, among other things:
Drawings, diagrams, and necessary explanations.
Documentation of the risk assessment and the relevant essential health and safety requirements applied.
Implemented protective measures and residual risks, where applicable.
Applied standards and technical specifications.
Relevant calculations, tests, and examinations.
A copy of the assembly instructions.
Documentation of internal measures for series manufacture.
Annex VII B of the Machinery Directive explicitly states that the documentation must show which essential health and safety requirements have been applied and fulfilled.
Annex IV B of the Machinery Regulation specifies that the documentation must demonstrate the means used by the manufacturer to ensure the conformity of the partly completed machinery with the relevant essential health and safety requirements.
The Machinery Regulation also introduces an explicit description of the intended function of the partly completed machinery when incorporated or assembled, more detailed provisions on standards and manufacturing methods, and conditional documentation requirements for safety-related software and certain sensor-guided systems.
The manufacturer must also draw up a declaration of incorporation under the applicable framework. The technical documentation, the declaration of incorporation, and the assembly instructions serve different purposes and must not be confused.
How Long Must Technical Documentation Be Kept?
Both the Machinery Directive and the Machinery Regulation require technical documentation to be kept available for at least ten years.
However, the retention period is calculated from different triggering events.
Product | Machinery Directive | Machinery Regulation |
|---|---|---|
Machinery | At least 10 years following the date of manufacture or of the last unit produced in the case of series manufacture | At least 10 years after the machinery has been placed on the market or put into service |
Partly completed machinery | At least 10 years following the date of manufacture or the last unit produced in the case of series manufacture | At least 10 years after the partly completed machinery has been placed on the market |
Annex VII of the Machinery Directive also clarifies that the documentation does not have to be permanently located within the EU or exist materially at all times. However, it must be capable of being assembled and made available in accordance with the provisions.
Articles 10(3) and 11(3) of the Machinery Regulation instead lay down the obligation for manufacturers to keep the technical documentation and relevant declarations at the disposal of market surveillance authorities for the specified period.
Pursuant to Articles 10(10) and 11(10), the manufacturer must provide a competent national authority, upon a reasoned request, with all necessary information and documentation, in paper or digital format.
What Language Must the Technical Documentation Be In?
According to Annex VII of the Machinery Directive, the technical construction file must be compiled in one or more official languages of the EU. Specific provisions govern the instructions.
Articles 10(10) and 11(10) of the Machinery Regulation state that information and documentation provided to a competent national authority upon a reasoned request must be in a language easily understood by that authority.
Instructions and assembly instructions are additionally subject to their own specific language provisions pursuant to Articles 10(7) and 11(7), respectively.
Therefore, a distinction must be made between language requirements for the internal technical file, documentation submitted to market surveillance authorities, and user instructions or assembly instructions intended for the customer or integrator.
Must Technical Documentation Accompany the Machine?
The complete technical documentation does not generally have to be supplied to the customer with the machine solely under the technical documentation provisions discussed here.
The manufacturer is, however, required to compile the documentation and make it available to the competent authorities pursuant to the applicable legislation.
Other documents are subject to specific delivery requirements.
Article 10(7) and 10(8) of the Machinery Regulation set out requirements for the instructions and the EU declaration of conformity. The regulation permits digital instructions under defined conditions, including requirements concerning accessibility, downloading, printing, and long-term availability.
The EU declaration of conformity must accompany the machinery or related product, or be made accessible via the internet address or machine-readable code specified in accordance with Article 10(8).
For partly completed machinery, specific requirements apply to assembly instructions and the EU declaration of incorporation under Article 11(7) and 11(8).
A distinction must therefore be made between the technical documentation that the manufacturer must keep available and the physical or digital access documents that must accompany the product.
How Should Technical Documentation Be Structured?
A machine may involve a substantial number of drawings, documents, calculation notes, test reports, and technical design justifications.
The primary challenge is often not drafting the documents, but ensuring version control, tracking safety measures, and preserving traceability for why a particular technical solution was selected.
A practical technical file structure might, for example, be organized into:
Machinery description and design specifications.
Risk assessment and applicable legal requirements.
Standards and technical specifications.
Protective measures and verification documentation.
Instructions and declarations.
Test reports, calculation notes, and supporting technical data.
This structure serves as an example and is not a rigid folder hierarchy prescribed by statute.
In Noex, risk assessments, legal requirements, protective measures, instruction manuals, inspection checklists, declarations, and other compliance files can be managed within a single project.
For complex machinery and process plants, machine registries and multi-level project structures are also available.
This allows organizations to maintain a standardized framework while tailoring the technical documentation to the specific machinery.
Frequently Asked Questions About Technical Documentation
Is the risk assessment part of the technical documentation?
Yes. Both the Machinery Directive and the Machinery Regulation mandate documentation of the risk assessment, including the procedure followed, the applicable essential health and safety requirements, implemented protective measures, and residual risks where applicable.
Must all drawings be included?
The Machinery Directive requires the drawings, explanations, and supporting documents specified in Annex VII A. It also expressly notes that detailed drawings of sub-assemblies need not be included unless knowledge of them is essential for verifying conformity with the safety requirements.
Annex IV A of the Machinery Regulation establishes distinct requirements for design and manufacturing drawings and schemes of the machinery, its components, sub-assemblies, and circuits. It does not contain the same explicit exemption wording as the Directive.
Is ISO 12100 mandatory?
No, there is no blanket legal requirement stipulating that ISO 12100 specifically must be applied. However, the manufacturer must satisfy the applicable safety requirements and document the risk assessment process. ISO 12100 is a harmonised standard that defines principles and methodology for risk assessment and risk reduction in machinery.
What is new in the Machinery Regulation's requirements for technical documentation?
Key additions include explicit provisions regarding safety-related source code or programming logic under certain conditions, and specialized documentation requirements for specific sensor-guided, remote-controlled, or autonomous systems. Other changes involve more precise documentation of intended use, standard application, and manufacturing quality control procedures.
How long must technical documentation be retained?
At least ten years under both regulatory regimes. The Machinery Directive calculates this period from the date of manufacture or the completion of the last unit in series production. Articles 10 and 11 of the Machinery Regulation calculate it from the date the product is placed on the market or, for machinery and related products, put into service according to the specified rules.
Can technical documentation be stored digitally?
Articles 10(10) and 11(10) of the Machinery Regulation explicitly state that information and documentation may be provided to a competent national authority in paper or digital format upon a reasoned request. Specific regulatory requirements govern user instructions, assembly instructions, and declarations.
Who is legally responsible for the technical documentation?
The manufacturer bears ultimate legal responsibility for compiling the technical documentation and making it available pursuant to the applicable legislation. Appointing a consultant or external engineering partner to assist with documentation does not transfer or diminish the manufacturer's statutory liability.
Summary
Technical documentation is a core requirement within the CE conformity assessment process for machinery.
It must demonstrate that the machinery satisfies the applicable essential health and safety requirements through risk assessments, design documentation, protective measures, and verification records.
The Machinery Regulation maintains much of the established framework, but clarifies several documentation obligations and introduces explicit requirements for areas such as safety-related software and certain sensor-guided or autonomous machinery.
The objective is not merely having files on hand, but ensuring they substantiate compliance with the requirements and can be presented whenever legally required.
Looking to streamline risk assessments, legal requirements, technical documentation, and compliance decisions in a unified platform?
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Regulatory References
Machinery Directive 2006/42/EC – Annex VII A and B.
Machinery Regulation (EU) 2023/1230 – Annex IV A and B, and Articles 10 and 11.
Frequently Asked Questions Regarding Technical Documentation for Machinery
What must the technical documentation for machinery contain?
The technical documentation must contain the data and supporting evidence required to demonstrate that the machinery complies with the applicable essential health and safety requirements (EHSRs). This includes, among other things, a general description of the machinery, technical drawings, risk assessment, harmonised standards applied, protective measures, relevant calculations, test results, and the instructions for use.
The specific requirements are set out in Annex VII A of the Machinery Directive and Annex IV A of the Machinery Regulation.
Is a risk assessment mandatory for CE marking of machinery?
Yes. Both the Machinery Directive and the Machinery Regulation require the manufacturer to document the risk assessment and the procedure followed.
The documentation must specify, among other elements, the applicable essential health and safety requirements, the protective measures implemented, and, where appropriate, information on residual risks.
ISO 12100 is a standard for risk assessment and risk reduction, but there is no general legal obligation stipulating that this specific standard must be applied.
Read more about machinery risk assessment in accordance with ISO 12100.
What changes will the Machinery Regulation 2027 introduce regarding technical documentation?
The Machinery Regulation (EU) 2023/1230 introduces more precise requirements concerning, among other aspects, the machinery description, the application of standards, and the documentation of manufacturing processes.
It also establishes explicit provisions regarding safety-related source code or programming logic upon a reasoned request from competent authorities, as well as specific documentation requirements for certain sensor-controlled, remotely controlled, and autonomous machinery.
The Regulation applies fully from 20 January 2027.
Must all technical drawings and component documentation be included?
The Machinery Directive requires the drawings, diagrams, explanations, and detail specifications referenced in Annex VII A. It provides an explicit derogation for certain detailed component drawings and specifications where these are not essential for verifying conformity with the safety requirements.
Annex IV A of the Machinery Regulation sets out its own requirements for design and manufacturing drawings, as well as schemes of components, sub-assemblies, and circuits. It does not contain the same explicit derogation wording.
For how long must technical documentation be retained?
Both the Machinery Directive and the Machinery Regulation establish a retention requirement of at least ten years of availability.
Under the Machinery Directive, this period is calculated from the date of manufacture of the machinery or, in the case of series manufacture, from the production of the last unit.
Under the Machinery Regulation, the retention period for machinery and related products is calculated from the date of placing on the market or putting into service. For partly completed machinery, it is calculated from the date of placing on the market.
Must technical documentation be supplied with the machinery?
No. The full technical documentation does not normally need to be provided to the customer solely pursuant to the technical documentation provisions of the Machinery Directive or the Machinery Regulation.
However, the manufacturer must draw up the documentation and be able to make it available to the competent national authorities in accordance with the applicable provisions.
Instructions for use, assembly instructions, and the relevant declarations are subject to specific requirements regarding the documents or access information that must accompany the product.
What documentation is required for partly completed machinery?
Partly completed machinery must have relevant technical documentation compiled in accordance with Annex VII B of the Machinery Directive or Annex IV B of the Machinery Regulation, depending on the applicable regulatory framework.
This documentation includes, among other elements, the risk assessment, applicable essential safety requirements, drawings, protective measures, applied standards, test reports, and the assembly instructions.
The manufacturer must also draw up a Declaration of Incorporation in accordance with the respective regulatory framework. Partly completed machinery must not be CE marked pursuant to the machinery legislation in the same manner as complete machinery.
Can machinery technical documentation be maintained in digital format?
Yes. Technical documentation may be managed digitally. In accordance with Articles 10(10) and 11(10) of the Machinery Regulation, the manufacturer must, upon a reasoned request, be able to provide the competent national authority with the necessary information and documentation in paper or digital format.
Digital instructions for use, assembly instructions, and EU Declarations are subject to specific requirements regarding availability and accessibility pursuant to Articles 10 and 11.
