Technical file for machinery: all CE requirements in detail
The technical file is a central component of CE marking. It demonstrates that the manufacturer has taken all applicable requirements into account. This article explains which documents are required under the Machinery Directive 2006/42/EC (Annex VII) and the new EU Machinery Regulation (Annex IV), what makes good operating instructions, and how to organise the documentation efficiently.
Why is the technical file so important?
The technical file fulfils several functions at once. First, it is the legal basis for CE marking: without complete documentation the manufacturer cannot issue a declaration of conformity. Beyond that, it serves as evidence towards market surveillance authorities that the machine meets the essential health and safety requirements.
In a liability case the technical file is often the decisive piece of evidence. If the manufacturer can demonstrate that it systematically assessed all risks and took appropriate protective measures, this strengthens its position considerably. If the documentation is missing or incomplete, the burden of proof is effectively reversed.
Under the Machinery Directive, the documentation must be available for at least 10 years after the last date of manufacture of the machine (Annex VII MD). For series machines this refers to the last unit produced. Under the Machinery Regulation (from 20 January 2027) the 10-year period runs from the placing on the market of the machine (Annex IV and Article 10 MR). The authorities may demand its production within a reasonable period.
Contents under MD Annex VII (currently in force)
The Machinery Directive 2006/42/EC defines in Annex VII Part A the minimum contents of the internal technical file. It must comprise the following:
1. General description of the machine
An overview description of the machine stating its intended use. This includes photos or drawings that convey an overall impression of the machine. All variants and options must be described as well.
2. Overall drawing and detailed plans
The overall drawing must show the general layout of the machine. Detailed drawings are required for all safety-relevant assemblies. Added to this are complete circuit diagrams: electrical circuit diagrams (for example per IEC 81346), pneumatic and hydraulic circuit diagrams, and control logic (for example PLC programs in documented form).
3. Complete risk assessment
The risk assessment must document the entire process: identification of all hazards in all life phases, evaluation of the risks with a traceable method (for example risk graph or risk matrix per EN ISO 12100), definition of the protective measures under the three-step method, and evaluation of the residual risks.
4. List of standards
A complete list of all harmonised standards and other technical specifications applied. For each standard, state which requirements it covers. Where a standard is applied in part, document which clauses were applied.
5. Test reports and evidence
All test reports and measurement results produced to verify conformity: EMC measurements, earthing measurements, noise emission measurements, validation of the safety functions (PL/SIL evidence), strength verification for load-bearing parts and the results of the functional tests.
6. Operating instructions
A copy of the operating instructions. The operating instructions are both part of the internal documentation and a document handed to the operator. Details of the requirements for the operating instructions follow further below.
7. EC Declaration of Conformity
A copy of the EC Declaration of Conformity per Annex II Part 1 Section A of the MD. It contains the identification of the manufacturer, the product designation, the directives and standards applied and the signature of the person empowered to draw up the declaration.
What changes with the Machinery Regulation (Annex IV)?
The new EU Machinery Regulation (EU) 2023/1230, which replaces the Machinery Directive from 20 January 2027, brings a number of changes to the technical documentation:
Digital operating instructions: for the first time, the Regulation allows the operating instructions to be provided in digital form. On request, however, the manufacturer must supply a free paper version within one month. Safety information must still be enclosed in paper form as well.
Cybersecurity documentation: for machinery with digital elements the documentation must now also cover the cybersecurity aspects. This includes measures against unauthorised access and manipulation as well as the strategy for security updates.
AI and machine learning: machinery that implements safety functions using AI or machine learning must document the training data and the learning logic. This is an entirely new requirement.
Substantial modification: for the first time, the Regulation defines clearly when a substantial modification of a machine exists and requires a new conformity assessment. The "new manufacturer" must supplement the documentation accordingly.
Note the transition date
The new Machinery Regulation becomes binding on 20 January 2027. Machinery first placed on the market after that date must meet the new documentation requirements. Start adapting your processes and templates in good time.
The operating instructions: requirements in detail
The operating instructions are the most important document for the operator of the machine. Annex I section 1.7.4 of the MD defines detailed requirements for their content. The key points:
Mandatory information in every set of operating instructions
- --Business name and full address of the manufacturer (and of the authorised representative, where applicable)
- --Designation of the machine (as marked on the machine)
- --EC/EU Declaration of Conformity or a reference to where it can be found
- --General description of the machine
- --Drawings, circuit diagrams and descriptions for operation, maintenance and repair
Content sections
- --Intended use: clear description of what the machine is intended for and which misuses are reasonably foreseeable
- --Transport and installation: weight, centre of gravity, lifting points, foundation requirements, connections
- --Commissioning: step-by-step instructions for initial commissioning and recommissioning
- --Operation: description of all operating functions, operating modes, settings
- --Maintenance and servicing: maintenance intervals, inspection points, wear parts, lubrication schedules
- --Troubleshooting: systematic guidance for diagnosing and rectifying typical faults
- --Dismantling and disposal: instructions for safe decommissioning and environmentally sound disposal
Safety instructions and warnings
All residual risks identified in the risk assessment must be listed in the operating instructions as safety instructions. They should be designed in accordance with ISO 7010 (safety signs) and ANSI Z535 (signal words):
Language requirements
The operating instructions must be drawn up in the official language of the country in which the machine is put into service. For the German-speaking countries (Germany, Austria, Switzerland) this means:
Germany: German
Austria: German
Switzerland: German, French, Italian (depending on the canton)
The MD distinguishes between the "original" version of the operating instructions and "translations". The original version bears the words "Original instructions", every translation the words "Translation of the original instructions". The manufacturer is liable for the accuracy of both versions.
The internal technical file (risk assessment, circuit diagrams and so on) may be drawn up in any official EU language agreed with the market surveillance authority. In practice, internal documents are frequently drawn up in German or English.
Partly completed machinery: the Declaration of Incorporation
Special documentation requirements apply to partly completed machinery. Instead of a declaration of conformity, a Declaration of Incorporation per Annex II Part 1 Section B of the MD is issued. The associated documentation comprises:
Assembly instructions stating the conditions under which the partly completed machinery may be incorporated into the final machinery
The relevant technical documents (risk assessment for the part the manufacturer is responsible for, circuit diagrams, interface description)
A statement of which essential health and safety requirements have been complied with and which remain to be fulfilled by the integrator
Partly completed machinery must not bear the CE marking. The Declaration of Incorporation also contains the express statement that the partly completed machinery must not be put into service until the final machinery complies with the requirements of the MD.
Practical tips for the documentation
Start early
Start the documentation as early as the concept phase. The risk assessment should accompany the design, not be caught up on at the end. That way you avoid costly changes.
Use templates and software
Use standardised templates and CE software to ensure consistency and reduce effort. Tools such as CE-Copilot offer AI-assisted suggestions and make sure no mandatory content is forgotten.
Introduce versioning
Introduce clear versioning for all documents. Whenever the machine is changed, the documentation must be updated. Every version must be traceable.
Archive centrally and securely
Store all documents centrally and protected. Cloud-based solutions have the advantage that the documentation is accessible at any time and from anywhere, including when the market surveillance authority requests it.
Compile your technical file digitally
CE-Copilot supports you in compiling the entire technical file: from the risk assessment to the EU Declaration of Conformity. AI-assisted and aligned with the standards.
More guides
CE marking checklist
All steps and documents at a glance.
Risk assessment per EN ISO 12100
The complete guide to a standard-compliant risk assessment.
Drawing up the declaration of conformity
Mandatory information and template for the EU Declaration of Conformity.
Machinery Directive 2006/42/EC
Scope, requirements and transition to the Machinery Regulation.