Regulations
Technical documentation under Machinery Regulation (EU) 2023/1230
What must contain the technical file according to the Machinery Regulation and how to prepare a compliant documentation.
What is the technical file of a car
The technical file is the set of documentation that demonstrates how a machine has been designed, built and verified to meet the applicable essential health and safety requirements. It does not coincide with the instructions for use and is not normally intended for the end customer: it is the technical basis with which the manufacturer demonstrates compliance during an inspection, a dispute or a request from an authority. Reference
An effective technical file must tell the machine in a verifiable way: what is, what is needed, what risks it presents, what measures have been taken, what standards have been applied, what tests have been carried out and what documents accompany the product.
Because the technical file is central to the CE marking
The CE marking is not a label to be applied at the end of the project. It is the result of a technical-documentary process. The technical file is the point where this process becomes demonstrable: it collects risk analysis, design solutions, schemas, calculations, tests, instructions for use, declarations and compliance checks.
If the file is incomplete, the machine can also be physically safe, but the manufacturer fails to prove it in an orderly manner. This is a serious problem in dealing with clients, notified bodies, supervisory authorities and, in worst cases, accidents or litigation.
What changes with the Regulation (EU) 2023/1230
2023/1230 will replace Directive 2006/42/EC from 20 January 2027. The logic of the technical file, which becomes the “technical documentation” remains the same: to demonstrate the conformity of the machine. However, it changes the setting of documentation, which is updated to better respond to software, autonomous systems, data of sensors, related products and new responsibilities of economic operators.
Annex IV of the Regulation describes the technical documentation for machines and related products. For manufacturers it is important to start the transition before the mandatory application, updating models, checklists, internal procedures and storage modes.
Minimum content of technical documentation according to Annex IV
Technical documentation must specify the means used by the manufacturer to ensure the conformity of the machine to the essential health and safety requirements applicable. Below is an operational reading of the main content to be prepared.
Description of the machine and intended use
The file must contain a complete description of the machine or the related product, including the intended use, limits, configuration, main technical characteristics and operating conditions. This section is stronger if it is already born from the specific design technique and not from a commercial description.
Risk assessment and applicable essential health and safety requirements
The heart of the technical file remains the risk assessment. The essential requirements applicable, hazards, protective measures adopted and any residual risks must be identified. This part must be consistent with the instructions for use and the technical solutions actually installed.
Drawings, schemes, calculations, tests and inspections
The file must include drawings, patterns, functional descriptions, calculations, test results, inspections and examinations necessary to verify the conformity of the machine. Here, for example, electric schematics, tire patterns, layouts, performance level calculations, electrical tests, acoustic measurements, EMC verifications and specific testing required by the project.
Harmonised standards, common specifications and alternative solutions Reference
The manufacturer must indicate the harmonised standards and any common specifications applied. If a standard is applied only in part, it is appropriate to indicate which parts have been used. If solutions other than those laid down in harmonised standards are adopted, the dossier must explain how these solutions meet the requirements.
instructions for use, declarations and documents of integrated components
A copy of the instructions for use, EU declaration of conformity, declarations of incorporation of integrated partly completed machinery, relevant assembly instructions and declarations of conformity of products or components subject to other EU harmonisation legislation must be present in the dossier.
safety software, autonomous systems and sensor data
One of the most delicate areas is digital software and systems. When relevant, the Regulation provides that the source code or software programming logic linked to safety may be made available to the competent authorities on a reasoned request, if necessary to verify compliance. For autonomous machines, remote or powered by sensor data, descriptions of the characteristics, capabilities, limitations and processes of development, testing and validation may be required.
Practical attention. The technical file should not be limited to collecting files. It must have a logical structure: index, references, revisions, responsibilities, links between requirements, risks, measures and verifications. Without this structure, even technically good documents become difficult to defend.
Conservation, updating and availability to authorities
The manufacturer must maintain technical documentation and the EU declaration of conformity available to market surveillance authorities for at least 10 years after placing on the market or commissioning the machine.
The technical file should also be updated when project changes, applied standards, critical components, software, safety circuits, intended use or machine configurations. For machines produced in series, it is also necessary to demonstrate how the conformity of production is maintained compared to the project validated.
Frequent errors in technical file management
file created only at the end of the contract, when many evidences are already dispersed;
risk analysis not consistent with instructions for use, schematics and installed protections;
absence of test reports or weak connection between tests and applicable requirements;
harmonised standards cited without indicating scope and limits;
calculations of Performance Levels not archived or not justified;
safety software not documented in a controlled way;
documents of the missing or not updated integrated components;
lack of control revisions and internal responsibility.
How Waves Engineering supports manufacturers
Waves Engineering supports manufacturers in building, revising and updating the CE technical file according to Machinery Directive and Regulation (EU) 2023/1230. The work may include risk analysis EN ISO 12100, RESS verification, test report collection, PL calculations, schematic verification, instructions for use review, declaration control and preparation of a document structure ready for audits or requests of authorities.
Our approach is practical: we transform technical documents dispersed into an orderly, traceable and useful file to demonstrate the conformity of the machine.
FAQ
Should the technical file be handed over to the customer?
Normally not. The technical file shall be held by the manufacturer and shall be made available to the competent authorities on a reasoned request. On the other hand, the customer is provided with instructions for use, declaration of conformity and documents.
How long does the technical file have to be kept?
The Regulation (EU) 2023/1230 provides for the conservation of technical documentation and the EU declaration of conformity for at least 10 years after placing on the market or commissioning.
Should the technical file include risk analysis?
Yes. Risk assessment and description of the protective measures taken are central elements of technical documentation.
Should safety software always be delivered?
Not indiscriminately. When relevant, the source code or programming logic may be made available to the competent authorities on a reasoned request, if necessary to verify compliance with the applicable requirements.
