Technical file checklist: Annex IV of the Machinery Regulation 2023/1230
Updated:
Under Regulation (EU) 2023/1230, the technical file for machinery must contain at least the fifteen elements of Annex IV, Part A, and for partly completed machinery the thirteen elements of Part B. Most of them map directly to Annex VII of Directive 2006/42/EC. The practical test is the same for every item: is it there, does it match the current product revision, and does it agree with the declaration and the instructions?
Which part applies
- Machinery and related products: Annex IV, Part A, required before placing on the market (Article 10(2)).
- Partly completed machinery: Annex IV, Part B, required before placing on the market (Article 11(2)).
The Regulation applies from 20 January 2027. For the wider changes, see what changes with Regulation 2023/1230.
Part A: machinery and related products
| Annex IV, Part A | What it must contain | Directive, Annex VII, Part A | What to check |
|---|---|---|---|
| (a) | Complete description of the machinery and its intended use | General description | Intended use stated, models and variants named |
| (b) | Risk assessment: list of applicable essential health and safety requirements, protective measures for each, residual risks | Same, in 1(a) | Cites Annex III of the Regulation, not Annex I of the Directive |
| (c) | Design and manufacturing drawings and schemes of the machinery, components, sub-assemblies and circuits | Overall, detailed and control circuit drawings | Revision index matches the product being shipped |
| (d) | Descriptions and explanations needed to understand (c) and how the machinery operates | Pertinent descriptions and explanations | Circuit descriptions match the drawings |
| (e) | References of harmonised standards or common specifications applied, and which parts if only partly | Standards and specifications used, with requirements covered | Editions and OJ references current |
| (f) | Other technical specifications used where (e) was not applied in full, per requirement | Partly covered in the standards item | Every requirement not covered by (e) has a stated solution |
| (g) | Reports or results of design calculations, tests, inspections and examinations | Calculation notes, test results, technical reports | Reports are dated and refer to the current design |
| (h) | Means used during production to ensure conformity with the design specifications | No separate item | Production checks described, not only referenced |
| (i) | Copy of the instructions for use and the information in Annex III, section 1.7.4 | Copy of the instructions | Same version as the one shipped |
| (j) | Where appropriate, declaration of incorporation and assembly instructions of incorporated partly completed machinery | Same | Present for every partly completed machine used |
| (k) | Where appropriate, declarations of conformity of incorporated machinery and products under other Union legislation | Same | Present, current, and citing current legislation |
| (l) | For series production, internal measures to keep conformity | Same, in 1(b) | Describes what happens when design or standards change |
| (m) | Source code or programming logic of safety-related software, on reasoned request | None | You can produce it if asked |
| (n) | For sensor-fed, remotely driven or autonomous machinery, characteristics, capabilities and limitations of the system and of its data, development, testing and validation | None | Only where safety-related operations depend on sensor data |
| (o) | Results of research and tests on components, fittings or the machinery to show safe assembly and putting into service | Required in the closing paragraph of 1 | Results filed, not only planned |
The Directive listed a copy of the declaration of conformity inside the technical file. Annex IV no longer lists it, but Article 10(3) still requires you to keep the EU declaration of conformity with the technical documentation for at least 10 years.
Part B: partly completed machinery
Part B follows the same pattern with points (a) to (m). Compared with Annex VII, Part B, of the Directive:
- (a) asks for a complete description of the partly completed machinery and its intended function when incorporated. The Directive's construction file started with drawings.
- (b) to (g) cover the risk assessment, drawings, explanations, standards, other specifications and reports, as before.
- (h) adds the means used during production.
- (i) is a copy of the assembly instructions, now set out in Annex XI (formerly Annex VI).
- (j) covers internal measures for series production.
- (k) and (l) add safety software source code on request and the description of sensor-fed, remotely driven or autonomous systems.
- (m) covers research and tests showing that the machinery can be assembled and incorporated safely.
The EU declaration of incorporation (Annex V, Part B) must state which Annex III requirements are applied and fulfilled and that the documentation was drawn up under Annex IV, Part B.
Common mistakes we see
These are the issues that come up most often when files are reviewed. Each is a documentation problem, and most can be fixed without touching the design.
1. Old revision references
The file index lists drawing revision C while the shop floor builds revision D. The manual quotes a standard edition that has since been replaced. Annex V asks the declaration to name the standards with the date of their OJ publication reference, so a mismatch between file, manual and declaration is easy to spot from outside.
2. Declaration still citing the Directive
For units placed on the market from 20 January 2027, a declaration that says "EC declaration of conformity", cites Directive 2006/42/EC or still has the Directive's fields will not fit Annex V of the Regulation. Look for the module applied, the notified body and certificate where relevant, and standards with dates.
3. Missing risk assessment or standards list
Some files hold test reports but no risk assessment, or a generic template with no machine-specific hazards. Point (b) needs the list of applicable requirements and the protective measure for each one. Point (e) needs the standards actually applied, including which parts if not all.
4. Values differing between datasheet and manual
Rated load, power, weight, dimensions and noise figures often differ between the datasheet, the instructions and the test report. Annex III, section 1.7.4.2(u) requires noise emission values in the instructions. A difference here raises the question of which one was tested.
5. Instructions missing for target-country languages
Instructions must be in a language users can easily understand, as decided by the Member State concerned (Article 10(7)). Distributors must check this before supplying (Article 15(2)(c)). The declaration must also be translated into the languages the Member State requires (Article 21(2)).
6. Expired supplier certificates
Certificates and test reports for bought-in safety components can run past their validity date. EC type-examination certificates issued under the Directive stay valid only until they expire (Article 52(2)). Supplier declarations may also still cite the Directive or withdrawn standards.
Short self-check
- Every Annex IV point is either present or marked "not applicable" with a reason.
- Drawing, manual and report revisions match the product being shipped.
- The risk assessment cites Annex III and lists a measure for each applicable requirement.
- The standards list gives editions, and the declaration gives the same.
- Technical data are identical in datasheet, instructions and test reports.
- Instructions and declaration exist in every target-country language.
- Supplier certificates and declarations are valid and current.
The Dossure quick check runs this kind of review on a file and shows what is missing, inconsistent or worth checking. The conclusions stay with you.
Frequently asked questions
- What must a technical file contain under Regulation (EU) 2023/1230?
- For machinery and related products, at least the fifteen elements in Annex IV, Part A, points (a) to (o): description and intended use, risk assessment, drawings and explanations, standards applied, test and calculation reports, production controls, instructions, incorporated declarations, series measures, safety software source code on request, sensor and autonomy description, and tests on safe assembly.
- Is Annex IV the same as Annex VII of Directive 2006/42/EC?
- Annex XII of the Regulation maps Annex VII, Parts A and B, of the Directive to Annex IV, Parts A and B. Most content carries over. New items include a description of production controls, safety-related source code on request, and a description of sensor-fed or autonomous systems.
- Do I have to put source code in the technical file?
- Annex IV, Part A, point (m) covers the source code or programming logic of safety-related software, to be made available on a reasoned request from a competent national authority where it is necessary to check the requirements of Annex III.
- How long must the technical documentation be kept?
- At least 10 years after the machinery is placed on the market or put into service (Article 10(3)), together with the EU declaration of conformity. For partly completed machinery, 10 years after placing on the market (Article 11(3)).
- Which language must the technical file be in?
- On a reasoned request, the manufacturer must provide the documentation in a language that the requesting authority can easily understand (Article 10(10)). The instructions for use follow the language rules of the Member State where the machinery is supplied.