Machinery Documentation Requirements: Technical File, Instructions and Declarations Compared

The manufacturer draws up all four and keeps the documentation and the declarations for at least 10 years.

These rules apply to products placed on the market or put into service from 20 January 2027; until 19 January 2027, Directive 2006/42/EC applies through national transpositions. How the documents fit into the rest of the EU Machinery Regulation is explained on the home page.

The sections below cover each document, retention, language, format, the Directive comparison and the status as of 12 November 2026.

What Documentation Does the Machinery Regulation Require?

The Machinery Regulation requires the manufacturer to draw up technical documentation before placing machinery or a related product on the market or putting it into service, to supply instructions with it, and to draw up an EU declaration of conformity once the conformity assessment procedure has demonstrated compliance (Article 10 of Regulation (EU) 2023/1230).

Article 10(2) of Regulation (EU) 2023/1230 fixes the order: the technical documentation (Annex IV, Part A) and the Article 25 procedure come first, then the EU declaration of conformity (Article 21) and the CE marking (Article 24).

Article 3(17) defines "instructions for use" as "the information, provided by the manufacturer when the machinery or related product is placed on the market or put into service, to inform the user".

Partly completed machinery follows Article 11 instead: Annex IV, Part B documentation, assembly instructions (Annex XI) and an EU declaration of incorporation (Article 22), with no CE marking. The other steps of Machinery Regulation compliance, from design to CE marking, are set out separately.

Who Draws Up, Keeps and Checks Each Document

The manufacturer draws up every document, and Article 12(1), second subparagraph, of Regulation (EU) 2023/1230 keeps the drawing up of the Annex IV technical documentation out of an authorised representative's mandate.

The authorised representative keeps documents instead: its mandate must at least allow it to hold the technical documentation and the declaration for national authorities (Article 12(2)(a)).

Before placing on the market, the importer checks that the Article 25 procedure was carried out, the Annex IV, Part A documentation drawn up, the CE marking affixed and Article 10(8) complied with (Article 13(2)).

The distributor verifies the CE marking, the EU declaration of conformity, instructions in a language easily understood by users as determined by the Member State and the markings of Articles 10(5), 10(6) and 13(3) (Article 15(2)).

Every economic operator keeps records of its suppliers and customers (Article 19(2)). The full list of obligations under the Machinery Regulation for each operator sits on its own page.

The Four Machinery Documents and Their Legal Basis

Four documents carry the documentation duties of Regulation (EU) 2023/1230, and each has its own article and annex: technical documentation (Articles 10 and 11, Annex IV), instructions (Article 10(7), Annex III section 1.7.4, with assembly instructions under Article 11(7) and Annex XI), the EU declaration of conformity (Article 21, Annex V Part A) and the EU declaration of incorporation (Article 22, Annex V Part B). Table 1 adds item counts and the Directive 2006/42/EC counterpart.

The EU declaration of conformity is drawn up for each machinery or related product model and identifies the model (Annex VI, point 4.2). It states that fulfilment of the applicable Annex III requirements "has been demonstrated" (Article 21(1)).

How Long Machinery Documents Must Be Kept

Machinery documents are kept for at least 10 years: 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 (Article 10(3) of Regulation (EU) 2023/1230).

The same minimum applies to partly completed machinery (Article 11(3)), the authorised representative (Article 12(2)(a)), importers (Articles 13(8) and 14(7)) and supplier and customer records (Article 19(2)); digital instructions and declarations stay online during the expected lifetime and for at least that minimum (Article 10(7)(c) and 10(8)). Table 2 lists the periods under Regulation (EU) 2023/1230, applicable from 20 January 2027.

Language Rules for Instructions, Declarations and Authority Requests

Instructions must be in "a language which can be easily understood by users, as determined by the Member State concerned", and they must be clear, understandable and legible (Article 10(7) of Regulation (EU) 2023/1230).

Maintenance instructions for specialised personnel mandated by the manufacturer or authorised representative may be in one official language of the Union which they understand (Annex III, section 1.7.4); assembly instructions are in a language easily understood by the person who incorporates the partly completed machinery, as determined by the Member State (Article 11(7)).

Both EU declarations are translated into the language or languages the Member State requires (Articles 21(2) and 22(2)), and documents for an authority, on reasoned request, are in a language easily understood by that authority (Article 10(10)).

Germany requires German from 20 January 2027 for the instructions, safety information, EU declaration of conformity, access notice for digital instructions, assembly instructions and EU declaration of incorporation (§ 2 Maschinenverordnung-Durchführungsgesetz, the German implementing act, BGBl. 2025 I Nr. 302). The language rules of other states are part of the machinery rules by country.

Paper or Digital Format: What Articles 10 and 11 Allow

Instructions may be supplied in digital format under Article 10(7) of Regulation (EU) 2023/1230, provided the product, its packaging or an accompanying document shows how to access them, the format can be printed, downloaded and saved, and they stay accessible online during the expected lifetime and for at least 10 years after placing on the market.

Access must work at all times, in particular during a breakdown, also where the instructions are embedded in the software.

Three paper safeguards remain, listed below.

• Paper on request: a user who asks at the time of purchase receives paper instructions free of charge within one month (Article 10(7), third subparagraph).
• Paper safety information: where non-professional users are intended or reasonably foreseeable, the safety information essential for putting into service and safe use is on paper (Article 10(7), fourth subparagraph).
• Distributors: under recital 40, manufacturers should ensure distributors can supply paper on request at purchase, free of charge.

The EU declaration of conformity accompanies the product, or the instructions give its internet address or machine-readable code (Article 10(8)); the declaration of incorporation has the same option through the assembly instructions (Article 11(8)).

Documentation under the Machinery Directive Compared

Under Directive 2006/42/EC, which applies until 19 January 2027, the manufacturer keeps the technical file of Annex VII for at least 10 years from the date of manufacture or, in series manufacture, from the last unit produced, and writes the instructions in the official Community language(s) of the Member State, marked "Original instructions".

Annex XII of the Regulation maps Directive Annex VII to Annex IV, Annex II to Annex V and Annex VI to Annex XI.

The Directive file need not be located in the Community nor permanently available in material form (Annex VII, Part A, point 2). Table 3 compares Directive 2006/42/EC and the Regulation point by point.

The Commission's Guide to application of the Machinery Directive 2006/42/EC, Edition 2.3 (April 2024), accepts digital instructions that respect Article 10(7) of the Regulation as compliant under the Directive. The full correlation of Machinery Regulation vs Machinery Directive sits on its own page.

Where Documentation Rules Stand on 2026-11-12

As of 12 November 2026, the documentation rules of Regulation (EU) 2023/1230 are not yet applicable (they apply from 20 January 2027), and machinery placed on the market in conformity with Directive 2006/42/EC before that date may still be made available afterwards (Article 52(1)).

The Commission proposed in COM(2025) 504 of 21 May 2025 that EU declarations of conformity and of incorporation be drawn up in digital format, with the product accompanied by the internet address or machine-readable code where the declaration can be accessed.

The proposal is pending, not adopted and not in the Official Journal as of 12 November 2026.

ISO 20607:2019 (instruction handbook) is to be revised (stage 90.92); its second edition, ISO/FDIS 20607, is a draft at stage 50.00 as of 12 November 2026. What EN ISO 20607 covers for writing the instruction handbook is set out on its own page.

Documentation for Modified, Rebranded and Partly Completed Machinery

Documentation duties pass to another person in two cases, a substantial modification (Article 18 of Regulation (EU) 2023/1230) and a product placed on the market under an importer's or distributor's name (Article 17), while partly completed machinery has its own document set (Article 11).

VDI 4500 Blatt 2 (November 2006 edition), a German guideline on organising and managing technical documentation, is current in the DIN Media catalogue as of 12 November 2026; it is guidance, not law.

Does a Modified Machine Need New Documentation?

Yes, if the modification is substantial: the person who makes it is considered a manufacturer with the Article 10 obligations, including the technical documentation, instructions and EU declaration of conformity, while a non-professional user modifying a machine for own use is not (Article 18). When a change counts as a substantial modification of machinery is set out separately.

Who Documents Machinery Sold under an Importer's or Distributor's Name?

The importer or distributor does: placing a product on the market under its own name or trademark, or modifying it so that compliance may be affected, makes it a manufacturer with the manufacturer's documentation duties (Article 17). The cases in which distributors become manufacturers are explained on their own page.

Which Documents Does Partly Completed Machinery Carry?

Partly completed machinery carries assembly instructions (Annex XI, 14 items) and an EU declaration of incorporation (Annex V, Part B, 9 points), and its manufacturer keeps the Annex IV, Part B documentation for at least 10 years after placing on the market (Article 11). The duties for partly completed machinery are explained in full on their own page.