Learn what a machinery technical file commonly contains, how to build traceable evidence and which documentation gaps to avoid.
What is a technical file?
A technical file is the collection of information the manufacturer uses to demonstrate how machinery meets applicable requirements. It is not one prescribed document and does not have to exist as a single folder beside the machine. Its relevant parts must be identifiable, current and available to competent authorities within the required period.
Machinery placed on the EU market up to 19 January 2027 will generally follow Machinery Directive 2006/42/EC. Machinery Regulation (EU) 2023/1230 applies from 20 January 2027. Always determine which other EU product rules also apply.
What does the file commonly contain?
The exact content depends on the machinery, its technology and all applicable legislation. A well-supported machinery file commonly contains the following information.
A general description and unambiguous identification of the machinery
Design and manufacturing drawings, diagrams and explanations needed to understand operation
The risk assessment, identified hazards, protective measures and residual risks
An overview of applicable essential health and safety requirements
Applied standards, technical specifications, calculations and test results
Instructions and relevant assembly or installation information
Declarations and documentation for incorporated machinery, components or safety components
The EU or EC declaration of conformity and details of the conformity assessment procedure
A step-by-step approach to traceable evidence
Start with scope: identify the machinery, variants, intended use, users and lifecycle phases. Determine the applicable EU rules and essential requirements. Perform the risk assessment while the design can still be changed, not after the machine is complete.
Link each relevant requirement and risk to specific design decisions, drawings, calculations, tests or instructions. Review the file before signing the declaration and manage later design changes as controlled revisions.
Common documentation gaps
A folder containing only a manual and supplier declarations is generally not a complete technical justification. Other common gaps include generic risk assessments, drawings without revision status, a standards list without links to requirements and a declaration that does not match the supplied configuration.
Pay particular attention to assemblies and production lines. Individual machines may have their own files, while the assembly requires additional assessment and documentation for interfaces and combined risks.
Managing the file in DME-CE
DME-CE starts with targeted questions about the product, intended use, users, functions and energy sources. Based on the answers, the software helps identify applicable supported directives and regulations and the essential requirements requiring assessment. Documentation remains assigned to the correct dossier for individual products, supplier products and assemblies.
In the legislation checklist, the team records its assessment, explanation and supporting evidence for every applicable requirement. The EN ISO 12100 risk assessment covers hazards, measures and residual risks, including a risk score before and after each measure. Drawings, calculations, standards, test reports and supplier declarations are organised in fixed categories and connected to the correct product or project.
Instructions are built from a consistent structure with guidance and examples for each chapter. Relevant questionnaire answers and residual-risk warnings can feed into the documentation, while a live PDF preview helps verify the final layout.
Teams can submit sections for review, process comments and maintain a traceable history of changes and revisions. Product, manufacturer and conformity data are reused in the EU Declaration of Conformity. Once complete, the entire CE dossier can be exported as one organised package for delivery and archiving.
DME-CE therefore supports the complete dossier workflow in one place without taking over the manufacturer’s responsibility for design decisions, technical assessments and conformity.