PLATE 04 OF 20
Technical documentation.
What the technical file must contain, how it is organised, and how it is kept aligned with change.
Pillar guide
Machinery technical file: anatomy of the evidence: Organise the technical record around the actual product, its risk assessment and the evidence supporting applicable requirements.
Supporting guides
| Guide | What it covers |
|---|---|
| Indexing a technical file | An index that lets another competent person find the evidence behind any requirement without relying on one engineer memory. |
| Drawings and design descriptions | Drawings and explanations that let a reviewer understand the design and operation of the machine as supplied. |
| Examinations, calculations and tests | The evidence groups in Annex IV that show a requirement was met, not merely claimed. |
| Keeping technical documentation for ten years | Retention duties under Article 10(3), and what availability to market surveillance authorities means in practice. |
| Keeping the file aligned with change | Product and production changes reviewed together across assessment, drawings, tests, and instructions. |
| Documentation for partly completed machinery | The separate documentation section for partly completed machinery, and how it differs from the complete machine file. |
| Supplier evidence in the technical file | How component declarations, test reports, and supplier data are checked and filed, rather than collected. |
| Reviewing a technical file before release | A review that asks whether the file explains the machine, not whether the folder looks full. |
| A digital technical file | Organising the file electronically so it stays retrievable, versioned, and complete over a ten year retention period. |
| Technical file and quality system records | How conformity evidence relates to production quality records, and where the two must not be confused. |