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Machinery CE technical file: required documents and traceability
Prepare model-matched risk, design, verification and instruction evidence rather than a generic CE document bundle.
Build a technical file for the actual machine
Directive Annex VII Part A connects the technical file to design, manufacture and operation. Include the machine description, drawings and control circuits, risk assessment, applied requirements, protective measures, relevant calculations and tests, and instructions. A folder of supplier certificates is not equivalent.
For partly completed machinery, Annex VII Part B, assembly instructions and the declaration of incorporation have a different role. Keep them as integration inputs. The final manufacturer must evaluate risks arising from the complete machine and its interfaces.
Match evidence to revisions and interfaces
A hypothetical file describes conveyor revision A while the delivered revision B has a different guard opening and controller. Link the delivered serial/model to the drawings and reports, assess the changes, and update the evidence before signing a declaration for that configuration.
Record which essential requirements each standard or technical solution addresses. Confirm the relevant published harmonised reference and limitations; the title of a standard alone does not prove that every requirement is covered. Test results need an identifiable sample and method.
Keep declarations and access responsibilities clear
Identify who can compile and make the technical file available to the competent authority. Under the Directive, retain it for at least ten years after manufacture, or the last unit for series production. Instructions and declarations accompany the machine as applicable; the whole file is not routinely supplied to every buyer.
Kayra can support the agreed product-file inventory and consistency checks. The manufacturer owns the design and conformity evidence. For supply from 20 January 2027, check the Regulation’s Annex IV documentation and Annex V declarations instead of reusing Directive annex numbers.
Related machinery guides
- Machinery CE marking: scope and machine safety
- When machinery CE marking is required: scope and exclusions
- Machinery CE questions: incorporation, electrical tests and line safety
- Machinery Regulation 2023/1230: the 2027 transition and later AI changes
- How to complete machinery CE conformity before supply
- Who is responsible for machinery CE marking and assessment?
- Choosing machinery CE technical support and assessment bodies
- Machinery CE costs and timescale: quote the actual work
- Checking machinery CE evidence: declaration, model and body status
- Machinery CE changes, certificate review and surveillance
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For “Machinery CE technical file: required documents and traceability”, share the machine function, current model and design revision, intended use, planned EU placement date and available risk or test records. Agreed product preparation work does not replace the manufacturer’s declaration or a legally required notified-body procedure.