The Machinery Regulation technical file (Annex IV)
The technical file is the evidence that your machinery meets the essential health and safety requirements. Annex IV Part A lists what it must contain for machinery; Part B covers partly completed machinery. It does not have to be a single bound document, and it does not have to be permanently assembled — but it must be capable of being produced to a market surveillance authority, in a reasonable time, for ten years.
Annex IV Part A — machinery
| Section | What it has to show |
|---|---|
| General description | What the machinery is, its intended use, and the foreseeable misuse you considered. |
| Overall drawing and control circuits | Plus the descriptions and explanations needed to understand how the machinery operates. A drawing without explanation fails this. |
| Detailed drawings, calculations, test results | Full drawings accompanied by any calculation notes and test results needed to check conformity with the essential requirements. |
| Risk assessment documentation | The procedure followed, the list of essential requirements that apply, the hazards identified, the risks evaluated, and the protective measures adopted. Detail → |
| Standards and specifications applied | Dated references to the harmonised standards or other technical specifications used, and which essential requirements each one covers. |
| Test reports | Reports of tests carried out by you, or by a body you or your customer chose. |
| Instructions | A copy of the instructions for use, in the form supplied. |
| Incorporated products | Where applicable, declarations of incorporation for partly completed machinery, assembly instructions, and declarations of conformity for machinery or other products incorporated. |
| EU declaration of conformity | A copy. Annex V content → |
| Series production measures | For series manufacture, the internal measures that keep every unit conforming. |
Annex IV Part B — partly completed machinery
Similar in shape, different in conclusion. The file must show which essential health and safety requirements have been applied and fulfilled, because the whole point of partly completed machinery is that not all of them can be. You produce a declaration of incorporation and assembly instructions rather than a declaration of conformity and an operator manual, and you do not affix CE marking.
How to organise it so it survives an audit
- Build a requirement-to-evidence index. One row per applicable Annex III requirement, one column for the evidence that satisfies it, one column for requirements judged not applicable with a one-line reason. This index is the single most valuable page in the file — it is the page an assessor reads first, and it is the page that proves you worked systematically rather than assembling documents afterwards.
- Date and version everything. A risk assessment with no date cannot be tied to a machine revision.
- Store references, not copies, where the source is controlled. But make sure the referenced item is retrievable for ten years — including from suppliers who may not last that long. For critical supplier documents, take a copy.
- Keep the file where somebody else can find it. A technical file that exists only on the engineering lead's laptop is, for regulatory purposes, a file that does not exist.
- Write it as you go. Every experienced compliance engineer says this and almost nobody does it. Reconstructing a risk assessment eighteen months after the design decisions is slower, more expensive, and produces a worse document.
Retention
At least ten years from placing on the market or putting into service. Where machinery is supplied in a series, from the last unit. If your company is sold or restructured, the obligation follows the product — plan for the file to be transferable.
Get told when the requirements change
None of the 35 CRA harmonised standards is published yet. When they land — and when deadlines move — we email you. No more than twice a month.