Documentation
Machinery Technical File: What the Technical Documentation Must Contain and How Long to Keep It
Machinery technical file under Regulation (EU) 2023/1230: Annex IV contents, changes from Annex VII, 10-year retention and who may request it.
Summary
The machinery technical file is the technical documentation a manufacturer draws up under Article 10(2) and Annex IV of Regulation (EU) 2023/1230 before placing machinery on the market, and keeps for at least 10 years after placing on the market or putting into service.
Annex IV has two parts: Part A with 15 points for machinery and related products, and Part B with 13 points for partly completed machinery.
The Machinery Regulation applies from 20 January 2027 and replaces Directive 2006/42/EC, whose Annex VII governs the technical file until 19 January 2027 through national law. From that date, the technical file of every product placed on the market or put into service follows Annex IV of the EU Machinery Regulation.
The sections below set out the Part A points, the Part B points, the changes from Annex VII, the retention periods, who may request the file and in which language, what notified bodies receive, and how to compile the file. The table gives seven core rules with their legal basis.
| Point | Rule | Legal basis |
|---|---|---|
| What | Annex IV, Part A (15 points) for machinery and related products; Part B (13 points) for partly completed machinery | Annex IV Regulation (EU) 2023/1230 |
| When | Drawn up before placing on the market or putting into service, together with the Article 25 procedure | Art. 10(2) Regulation (EU) 2023/1230 |
| Who drafts | The manufacturer; not part of an authorised representative's mandate | Art. 12(1), second subparagraph, Regulation (EU) 2023/1230 |
| Keep | At least 10 years after placing on the market or putting into service | Art. 10(3) Regulation (EU) 2023/1230 |
| Who may request | Competent national authorities, on a reasoned request | Art. 10(10) Regulation (EU) 2023/1230 |
| Applies from | 20 January 2027; Annex VII of Directive 2006/42/EC until 19 January 2027 | Art. 54 (as corrected) and Art. 51(2) Regulation (EU) 2023/1230 |
| Design basis | The applicable essential health and safety requirements of Annex III | Art. 10(1) Regulation (EU) 2023/1230 |
What Is the Machinery Technical File?
The machinery technical file is the set of documents listed in Annex IV of Regulation (EU) 2023/1230, Part A for machinery and related products (Article 10(2)) and Part B for partly completed machinery (Article 11(2)), which the manufacturer draws up before the product reaches the market.
Annex IV states that the documentation "shall specify the means used by the manufacturer to ensure the conformity" with the applicable Annex III requirements, and lists at least 15 elements, (a) to (o), in Part A and 13, (a) to (m), in Part B. Competent national authorities can ask for it on a reasoned request (Article 10(10)).
The technical file is one of four kinds of machinery documentation the manufacturer produces, next to the instructions for use, the EU declaration of conformity and, for partly completed machinery, the declaration of incorporation with its assembly instructions. How the four documents relate is explained under machinery documentation: technical file, instructions and declarations.
Technical File, Technical Construction File and Technical Documentation: One Document Set
Annex IV of Regulation (EU) 2023/1230 is titled "Technical documentation", while Annex VII of Directive 2006/42/EC speaks of the "technical file" for machinery and the "relevant technical documentation" for partly completed machinery.
Annex XII of the Regulation, the correlation table, maps Directive Annex VII to Annex IV and Directive Article 5 to Articles 10 and 11.
"Technical construction file" and its short form "TCF" are other names for the same document set; neither annex carries that title. Annex IV of Directive 2006/42/EC is a different thing altogether: it is the Directive's list of high-risk machinery, not the technical file.
What Annex IV, Part A Requires for Machinery and Related Products
Annex IV, Part A of Regulation (EU) 2023/1230 lists 15 points, (a) to (o), and three of them are new compared with Directive 2006/42/EC: the production means (h), the source code or programming logic of safety-related software on reasoned request (m), and the description of sensor-fed, remotely-driven or autonomous systems (n).
Two further points are not new. Point (k) widens the Directive's copies of declarations to any incorporated product covered by other Union harmonisation legislation, and point (o) lists the research and test results that Annex VII, Part A, point 1 of the Directive already required in the file.
The manufacturer draws up this documentation itself: under Article 12(1), second subparagraph, drawing up the Annex IV technical documentation is not part of an authorised representative's mandate. The 15 points are summarised below in the order of Annex IV.
| Point | Content | New vs Directive Annex VII | Detail |
|---|---|---|---|
| (a) | Complete description of the product and its intended use | Counterpart in Annex VII, Part A | |
| (b) | Risk assessment documentation: (i) list of applicable essential health and safety requirements; (ii) protective measures for each, and residual risks when appropriate | Annex VII, Part A, point 1(a), fourth indent | machinery risk assessment method |
| (c) | Design and manufacturing drawings and schemes of the product, components, sub-assemblies and circuits | Counterpart in Annex VII, Part A | |
| (d) | Descriptions and explanations needed to understand the drawings and the operation | Counterpart in Annex VII, Part A | |
| (e) | References of the harmonised standards (Art. 20(1)) or common specifications (Art. 20(3)) applied, with the parts applied | Counterpart in Annex VII, Part A | harmonised standards for machinery |
| (f) | Other technical specifications applied where standards or common specifications were not or only partly applied | Counterpart in Annex VII, Part A | |
| (g) | Reports or results of design calculations, tests, inspections and examinations | Counterpart in Annex VII, Part A | |
| (h) | Means used during production to ensure conformity with the design specifications | New | |
| (i) | Copy of the instructions for use and the Annex III, section 1.7.4 information | Counterpart in Annex VII, Part A | |
| (j) | Where appropriate, the EU declaration of incorporation and the Annex XI assembly instructions | Directive Article 13(2) | |
| (k) | Where appropriate, copies of the EU declarations of conformity of incorporated products | Widened | |
| (l) | For series production, internal measures to keep products in conformity | Annex VII, Part A, point 1(b) | |
| (m) | Source code or programming logic of safety-related software, on reasoned request | New | |
| (n) | Description of sensor-fed, remotely-driven or autonomous systems, where appropriate | New | autonomous mobile machinery |
| (o) | Results of research and tests showing the product can be assembled and put into service safely | Not new (Annex VII, Part A, point 1) |
Full text and annexes: Regulation (EU) 2023/1230 full text; consolidated version on EUR-Lex.
Risk Assessment Documentation in the File (Point (b))
Point (b) of Annex IV, Part A requires documentation on the risk assessment demonstrating the procedure carried out, including the list of applicable essential health and safety requirements and a description of the protective measures implemented to meet each of them and, when appropriate, the residual risks.
Annex VII, Part A, point 1(a), fourth indent of Directive 2006/42/EC asked for the same documentation in substance, while the Regulation ties every protective measure to "each applicable" requirement.
The Commission's Guide to application of the Machinery Directive 2006/42/EC, Edition 2.3 (April 2024), accepts that elements (i) and (ii) take the form of a checklist of the applicable requirements and the protective measures. The procedure behind that checklist is the machinery risk assessment method.
Standards and Other Technical Specifications (Points (e) and (f))
Point (e) records the references of the harmonised standards (Article 20(1)) or common specifications (Article 20(3)) applied, naming the parts where a standard is applied only in part, and point (f) describes the other technical specifications used where they are not applied or applied only in part.
Point (f) ties those other specifications to each applicable essential health and safety requirement. Part B carries the same two points, (e) and (f), for partly completed machinery.
Source Code and Sensor-Fed Systems (Points (m) and (n))
Point (m) requires "the source code or programming logic of the safety related software to demonstrate the conformity of the machinery or related product with this Regulation further to a reasoned request from a competent national authority provided that is necessary in order for those authorities to be able to check compliance with the essential health and safety requirements set out in Annex III".
Article 3(35) defines source code as "the currently installed version of the software of a product within the scope of this Regulation, written in a programming language so that it is unambiguous and understandable to humans".
Access to that software code runs through Articles 10(3), 11(3) and 13(8): competent national authorities receive it on a reasoned request, where necessary to check the Annex III requirements. Part B carries the counterparts as points (k) and (l). Software that performs a safety function is covered under software safety components under the Machinery Regulation.
Point (n) applies "for sensor-fed, remotely-driven, or autonomous machinery or related products, if the safety related operations are controlled by sensor data". It requires "a description, where appropriate, of the general characteristics, capabilities and limitations of the system, data, development, testing and validation processes used".
Annex IV, Part B: Technical Documentation for Partly Completed Machinery
Article 11(2) of Regulation (EU) 2023/1230 requires the manufacturer of partly completed machinery to draw up the technical documentation of Annex IV, Part B, which has 13 points, (a) to (m), and to keep it for at least 10 years after the partly completed machinery is placed on the market (Article 11(3)). Point (a) describes the product and its intended function once incorporated.
Point (b) holds the risk assessment documentation with the requirements that apply and the protective measures, with residual risks where appropriate, and point (i) a copy of the Annex XI assembly instructions.
Points (e) and (f) match Part A, points (k) and (l) mirror Part A points (m) and (n), and point (m) records the tests showing that the product can be assembled and incorporated safely.
The Directive counterpart is Annex VII, Part B of Directive 2006/42/EC, required by its Article 13(1)(a). The other Article 11 duties, from assembly instructions to the declaration of incorporation, are set out under partly completed machinery under the Machinery Regulation.
Annex IV vs Directive Annex VII: What Changed in the Technical File
Annex IV of Regulation (EU) 2023/1230 replaces Annex VII of Directive 2006/42/EC from 20 January 2027, adds three content points, drops the copy of the declaration of conformity from the list and starts the 10-year retention clock at placing on the market or putting into service instead of the date of manufacture.
The eight differences are compared below.
| Item | Machinery Directive 2006/42/EC | Regulation (EU) 2023/1230 |
|---|---|---|
| Annex | Annex VII, Parts A and B | Annex IV, Parts A and B |
| Legal duty | Art. 5(1)(b); Art. 13(1)(a) for partly completed machinery | Art. 10(2); Art. 11(2) for partly completed machinery |
| Copy of the declaration of conformity | Listed in the file | Not listed; kept together with the file under Art. 10(3) (EU declaration of conformity for machinery) |
| New content points | None | (h), (m), (n) |
| Risk assessment | Annex VII, Part A, point 1(a), fourth indent | Point (b) |
| Language | One or more official Community languages | A language easily understood by the requesting authority |
| Retention clock | From the date of manufacture or, in series manufacture, the last unit produced | From placing on the market or putting into service |
| "Person authorised to compile the technical file" in the declaration | Yes | No |
The Directive's EC declaration of conformity named "the person authorised to compile the technical file, who must be established in the Community" (Annex II, point 1, section A, point 2). Annex V, Part A of the Regulation, the content of the EU declaration of conformity, has no such item.
The declaration itself leaves the list of file contents but not the archive: Article 10(3) and Annex VI, point 4.2 require it to be kept together with the technical documentation. The Directive wording is on EUR-Lex, and every change beyond the file is listed under Machinery Regulation vs Machinery Directive.
How Long to Keep the Technical File: Retention Periods by Act and Operator
Under Article 10(3) of Regulation (EU) 2023/1230, the manufacturer keeps the technical documentation and the EU declaration of conformity for at least 10 years after the machinery or related product has been placed on the market or put into service.
Directive 2006/42/EC counted the same minimum of 10 years from the date of manufacture or, in series manufacture, from the last unit produced (Annex VII, Part A, point 2), and applied that clock to the documentation for partly completed machinery as well (Annex VII, Part B).
The 10-year retention duty extends along the supply chain. Importers keep a copy of the declaration and ensure the Part A documentation can be made available (Article 13(8); Article 14(7) for partly completed machinery), the authorised representative's mandate must cover keeping the documentation (Article 12(2)(a)), and every economic operator keeps the identity of its suppliers and customers (Article 19(2)).
A notified body keeps a module B certificate and file for five years after the certificate expires, against 15 years from issue for the Directive's EC type-examination. The periods are compared below.
| Who | What | Minimum period | Clock starts | Legal basis |
|---|---|---|---|---|
| Manufacturer | Technical documentation and EU declaration of conformity | 10 years | Placing on the market or putting into service | Art. 10(3), Annex VI point 4.2 Regulation (EU) 2023/1230 |
| Manufacturer of partly completed machinery | Technical documentation and declaration of incorporation for partly completed machinery | 10 years | Placing on the market | Art. 11(3) Regulation (EU) 2023/1230 |
| Importer | Copy of the declaration; documentation available (importer obligations for machinery) | 10 years | Placing on the market | Art. 13(8); Art. 14(7) for partly completed machinery |
| Authorised representative | Documentation and declarations, under the mandate | 10 years | Placing on the market | Art. 12(2)(a) Regulation (EU) 2023/1230 |
| Every economic operator | Identity of suppliers and customers | 10 years | Supplying or being supplied | Art. 19(2) Regulation (EU) 2023/1230 |
| Notified body, module B | Certificate and technical file (EU type-examination for machinery) | 5 years | Expiry of the certificate | Annex VII point 8 Regulation (EU) 2023/1230 |
| Manufacturer under the Directive | Technical file; relevant technical documentation for partly completed machinery | 10 years | Date of manufacture or last unit produced | Annex VII, Parts A and B, Directive 2006/42/EC |
| Manufacturer and notified body, Directive EC type-examination | Certificate and technical file | 15 years | Date of issue | Annex IX points 4 and 9.3 Directive 2006/42/EC |
Who May Request the Technical File, in Which Language and Format
Competent national authorities may request the technical file: on a reasoned request, the manufacturer provides the information and documentation in paper or digital format, in a language easily understood by that authority (Article 10(10) of Regulation (EU) 2023/1230).
For source code and programming logic, the stricter condition of point (m) applies: the authority must need it to check the Annex III requirements.
The request can also reach operators other than the manufacturer. An importer must be able to make the Part A documentation available to the authorities (Article 13(8)), and the mandate of an authorised representative covers providing information and documentation on a reasoned request (Article 12(2)(b)). The mandate and its limits are explained under authorised representative for machinery.
Directive 2006/42/EC asked for a technical file in one or more official Community languages (Annex VII, Part A) and stated that a failure to present it in response to a duly reasoned request may constitute sufficient grounds for doubting conformity (Annex VII, Part A, point 3).
The Commission's guide to the Directive, Edition 2.3, adds three practical points. Documents in a non-EU language are translated into an official EU language, supplier documents already in another official EU language need no translation, and the manufacturer has no obligation to hand elements of the technical file to customers or the distribution chain.
What Notified Bodies Receive from the Technical File under Modules B, H and G
A notified body sees the technical file only where Article 25(2) or (3) of Regulation (EU) 2023/1230 routes the product through module B with C, module H or module G; under module A the file stays with the manufacturer.
Under module B the application to a single notified body includes the Part A documentation and access to specimens (Annex VII, point 3), and the body does not take points (h) and (l) into account (point 4(a)).
Under module H the manufacturer submits points (a) to (g), (i) to (k) and (m) to (o) for one model of each category (Annex IX, point 3.1(b)). The four modules are compared below.
| Module | What the notified body receives | Retention | Legal basis |
|---|---|---|---|
| A (internal production control for machinery) | Nothing: the file stays with the manufacturer | Manufacturer: 10 years | Annex VI point 4.2 |
| B + C (EU type-examination for machinery) | Part A documentation without points (h) and (l), plus access to specimens | Certificate valid at most 5 years; body keeps it 5 years after expiry; manufacturer 10 years | Annex VII points 3, 4(a), 6.1, 8, 9; Annex VIII |
| H (full quality assurance (module H) for machinery) | Points (a) to (g), (i) to (k) and (m) to (o) for one model of each category | Manufacturer: 10 years | Annex IX points 3.1(b) and 6 |
| G (unit verification for one-off machines) | The single unit for examinations and tests | Manufacturer: documentation and certificates 10 years | Annex X points 2.1 and 4 |
EC type-examination certificates issued under Directive 2006/42/EC remain valid until they expire (Article 52(2) of Regulation (EU) 2023/1230). Which module a product needs is set out under conformity assessment under the Machinery Regulation.
How to Compile a Technical File That Meets Annex IV
Compiling a technical file under Regulation (EU) 2023/1230 takes six steps, from identifying the product category to setting the 10-year retention clock. The six steps are listed below.
- Confirm whether the product is machinery, a related product or partly completed machinery, and so whether Annex IV, Part A or Part B applies.
- Document the risk assessment for point (b): the applicable requirements, the protective measures for each and the residual risks.
- Record the harmonised standards or common specifications applied under point (e), and the other technical specifications under point (f).
- Add the new points where they apply: production means (h), source code or programming logic (m) and the sensor-fed system description (n).
- Check the conformity route and which file points a notified body will receive, using the machinery conformity route finder.
- Store the file together with the EU declaration of conformity for at least 10 years after placing on the market or putting into service.
Who Draws Up the Technical File and What Happens When It Is Missing
The manufacturer draws up the technical file and cannot hand that task to an authorised representative, and whoever substantially modifies a machine becomes its manufacturer with the same Article 10 duties. Four related rules shape who holds the file and what follows from it.
- Substantial modification: the person who carries it out is a manufacturer with the Article 10 obligations (Article 18), see substantial modification of machinery.
- Importers: before placing on the market, the importer checks that the Annex IV, Part A documentation has been drawn up (Article 13(2)), see importer obligations for machinery.
- Instructions: they are a separate document, and Article 10(7) allows them in digital format, see machinery instructions and digital format rules.
- Germany: from 20 January 2027, not keeping the technical documentation or the declaration for 10 years is an administrative offence under § 9(1) nos 1 and 10 of the MaschinenDG, with a fine of up to EUR 10,000 (§ 9(2)), see machinery rules in Germany.
Under Article 46(1)(e) of Regulation (EU) 2023/1230, technical documentation that is unavailable or incomplete is a formal non-compliance finding. It is one of seven formal findings, (a) to (g), next to a missing CE marking and a missing or incorrect EU declaration of conformity, as explained under market surveillance of machinery.
Technical File Questions
Three questions recur about the technical file: where it must be kept, whether the declaration of conformity belongs in it, and which rules apply before 20 January 2027.
Does the technical file have to be kept inside the EU?
Directive 2006/42/EC states that the technical file does not have to be located in the territory of the Community nor be permanently available in material form (Annex VII, Part A, point 2). Annex IV of Regulation (EU) 2023/1230 has no counterpart sentence, and an authorised representative's mandate must allow it to keep the technical documentation for at least 10 years (Article 12(2)(a)).
Does the EU declaration of conformity belong in the technical file?
Annex IV, Part A of Regulation (EU) 2023/1230 no longer lists a copy of the declaration of conformity, which Annex VII, Part A of Directive 2006/42/EC did, but Article 10(3) requires both to be kept for at least 10 years. Point (k) still asks, where appropriate, for copies of the EU declarations of conformity of incorporated machinery, related products and products covered by other Union harmonisation legislation.
Which technical file rules apply to machinery placed on the market before 20 January 2027?
Machinery placed on the market until 19 January 2027 follows Annex VII of Directive 2006/42/EC, and every product placed on the market or put into service from 20 January 2027 must meet Regulation (EU) 2023/1230, including Annex IV. Products placed on the market under the Directive before that date may continue to be made available, and there is no parallel period in which the manufacturer may choose (Article 52(1)); all dates are in the Machinery Regulation timeline.