DEFINITION
The technical documentation demonstrates a product's compliance with the relevant requirements and must be made available to authorities upon request. The content and retention periods are defined in the respective legal act.
DeclarationTechnical Documentation
Typical components include the product description, design and manufacturing documentation, applied standards, risk assessment, test and measurement reports, instructions, markings and the EU Declaration of Conformity. The documentation must enable the reproduction of the design and the assessment of conformity.
Organisations should maintain structured files with version control, define responsibilities and monitor retention periods. Digital signatures and access logs facilitate verification and auditing.
Key Points
- Retention periods per legal act.
- Versioning and traceability are audit-critical.
Related Terms
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