Machinery Regulation (EU) 2023/1230 – documentation obligations

The Machinery Regulation (EU) 2023/1230 is the new EU legal basis for the safety of machinery and related products. From 20 January 2027, it replaces the Machinery Directive 2006/42/EC. As a regulation, it applies directly in all Member States without transposition into national law.

This page focuses on what matters for documentation: instructions for use, the EU declaration of conformity, technical documentation and the roles of manufacturers, importers and distributors. For each topic, you will find references to in-depth guides.

From when does the Machinery Regulation 2023/1230 apply?

The Regulation was published in the Official Journal of the EU (OJ L 165, 29.6.2023, p. 1). It entered into force on the twentieth day following its publication, i.e. on 19 July 2023. However, it essentially only applies from 20 January 2027.

“It shall apply from 20 January 2027.”

Entry into force means that a legal act exists legally. Application (applicability) means that companies must fulfil its obligations. Between these two dates lies the preparation period, during which certain parts already apply earlier.

What applies to machinery placed on the market before 2027?

Placing on the market means the first making available of an individual product on the EU market. Article 52 governs the transition: Member States must not impede the making available on the market of products covered by Directive 2006/42/EC “which were placed on the market before 20 January 2027”.

According to a widespread interpretation, what matters is the individual unit, not the model. This has practical consequences:

What is new compared with the Machinery Directive?

The Regulation adopts many principles of the Directive but supplements them in important respects. For documentation, the following changes are particularly relevant:

• Digital instructions for use in the legal text: Article 10(7) expressly permits the digital format and attaches conditions to it.
• Digital EU declaration of conformity: Instead of enclosing it, an internet address or a machine-readable code is alternatively sufficient under Article 10(8).
• Obligations of all economic operators: Importers and distributors are given their own, detailed verification obligations (Articles 13–16).
• Substantial modification: defined for the first time, expressly also covering digital modifications such as software (Article 3(16), Article 18).
• Cybersecurity and AI: new requirements in Annex III and new categories in Annex I.
• Extended contact details: In addition to the postal address, a website, email address or other digital contact must be indicated (Article 10(6)).

According to our review, the terms “original instructions” and “translation of the original instructions” no longer appear in section 1.7.4 of Annex III of the Regulation. This point still needs to be verified against the authoritative EUR-Lex version. A detailed comparison can be found in the guide Machinery Directive vs. Machinery Regulation.

What obligations do manufacturers, importers and distributors have?

An economic operator is any person or company in the supply chain that bears its own obligations under the Regulation – above all manufacturers, importers and distributors. An importer is an operator established in the EU that places a product from a third country on the EU market. A distributor makes available a product that has already been placed on the market.

Separate rules apply to partly completed machinery: assembly instructions in accordance with Annex XI and the EU declaration of incorporation in accordance with Part B of Annex V, also permitted in digital format (Articles 11, 14, 16).

Importers sourcing machinery from Asia, for example, should not wait until goods receipt to check the documents. What you should agree contractually with the manufacturer is explained in the guide Obligations for importers and distributors. An overview for your target group can be found under Importers and Manufacturers.

Instructions for use and EU declaration of conformity: what applies?

The instructions for use are the information provided by the manufacturer on the safe use, servicing and maintenance of a machine. They must accompany the machine, but may be provided in digital format.

“Manufacturers shall ensure that the machinery or related product is accompanied by the instructions for use and information set out in Annex III. The instructions for use may be provided in digital format.”

Important: digital instructions for use are permitted, not mandatory. Paper remains permissible. All details on implementation – QR code, formats, paper requests – can be found in the guide digital instructions for use and in the guides Instructions for use via QR code and Paper copy on request.

The EU declaration of conformity (EU DoC) is the declaration by which the manufacturer assumes responsibility for the product's compliance with the Regulation. Its content and form are governed by Article 21 and Part A of Annex V. It must be kept up to date; where several EU legal acts apply, a single declaration is sufficient (Article 21(3)).

“[…] or alternatively the manufacturers shall indicate in the instructions and information set out in Annex III, section 1.7, the internet address or machine-readable code where that EU declaration of conformity can be accessed.”

A digitally provided EU DoC must be available online for the expected lifetime, but at least for ten years after placing on the market or putting into service. More on this in the guide Providing the EU declaration of conformity digitally.

Technical documentation: what must be kept, and for how long?

The technical documentation is the documentation with which the manufacturer demonstrates that its product meets the requirements – for example the risk assessment, drawings, test reports and applied standards. It is addressed to market surveillance, not to the user.

Under Article 10(3), manufacturers keep the technical documentation and the EU DoC “at the disposal of the market surveillance authorities for at least 10 years”. What is new: upon a reasoned request, the authority may also require source code or programming logic insofar as this is necessary for checking conformity.

Do not confuse two ten-year periods:

How to secure both periods even in the event of a website relaunch or a change of provider is described in the guide Instructions for use online for 10 years.

What is a substantial modification?

Under Article 3(16), a substantial modification is “a physical or digital modification” after placing on the market or putting into service “which is not foreseen or planned by the manufacturer”. It exists where a new hazard or an increased risk makes additional protective devices or protective measures necessary.

What is new is the express inclusion of digital modifications, for example through software updates. The consequence is governed by Article 18: anyone who substantially modifies a machine “shall be considered a manufacturer for the purposes of this Regulation”. This also affects operators and integrators – with all documentation obligations, including new instructions for use and a new EU DoC. Non-professional users who carry out modifications for their own use are exempt.

Which conformity assessment procedure applies (Annex I)?

Conformity assessment is the procedure used to demonstrate that a product meets the requirements. Under Article 25, which procedure applies depends on the classification in Annex I:

For most machinery of small and medium-sized manufacturers, internal production control remains the procedure. Nevertheless, check every product line against the lists in Annex I.

What does the Regulation provide on cybersecurity and AI?

Section 1.1.9 of Annex III requires “protection against corruption”: the connection of a device or remote access must not lead to a hazardous situation. Under section 1.2.1, control systems must log interventions and uploaded versions of the safety software, namely “for up to five years after uploading”.

On AI, points 5 and 6 of Part A of Annex I list safety components and machinery with embedded systems with “fully or partially self-evolving behaviour using machine learning approaches” ensuring safety functions. They are subject to assessment by a notified body.

According to a secondary source, Regulation (EU) 2026/1744 (“Digital Omnibus on AI”) amended the Machinery Regulation in July 2026; the Commission is to include AI requirements in Annex III by delegated act in future. This amendment should be checked in the Official Journal before you base your planning on it.

What applies in Germany? The MaschinenDG

The Maschinenverordnung-Durchführungsgesetz (MaschinenDG), the German act implementing the Machinery Regulation, governs the German supplementary provisions to the Regulation, above all language, market surveillance and penalties. It was signed into law on 2 December 2025 (BGBl. 2025 I No. 302, German Federal Law Gazette). Under § 12, §§ 1, 2, 4 and 8 to 11 apply from 20 January 2027. According to the government bill (BT-Drs. 21/1507), the previous 9. ProdSV (Ninth Ordinance to the German Product Safety Act, the former Machinery Ordinance) ceases to have effect at the end of 19 January 2027.

Which language does Germany require?

Under § 2 MaschinenDG, the instructions for use, the information under Article 10(7), first subparagraph, the safety information under the fourth subparagraph and the EU declaration of conformity must be “drawn up in German”. For partly completed machinery, this applies accordingly to the assembly instructions and the declaration of incorporation.

An EU-wide exception applies: maintenance instructions intended for specialised personnel mandated by the manufacturer may be drawn up in an official language understood by that personnel (section 1.7.4 of Annex III). For other target countries, each Member State determines the language itself – details in the guide Language of the instructions for use.

What fines may be imposed in Germany?

“[…] in the cases of paragraph 1 numbers 7, 16 and 17 with a fine of up to one hundred thousand euros, in all other cases with a fine of up to ten thousand euros”

Roadmap for SMEs up to 20 January 2027

For small and medium-sized manufacturers and importers, only a few months remain. The following sequence of steps has proven effective:

1. Take stock: List all machine types and partly completed machinery that you expect to still place on the market after 19 January 2027.
2. Clarify your role: Determine for each product whether you are the manufacturer, importer or distributor – and whether Article 17 (own brand) applies.
3. Check Annex I: Assign each product to a category and determine the conformity assessment procedure; for Part A, plan for a notified body at an early stage.
4. Update the risk assessment: Take the new requirements into account, in particular cybersecurity and software.
5. Revise documents: Instructions for use in accordance with section 1.7.4 of Annex III, EU DoC in accordance with Part A of Annex V, contact details in accordance with Article 10(6), German language version under § 2 MaschinenDG for Germany.
6. Decide on the form of provision: Paper, digital or combined. For the digital format, define the access indication, download format, paper request process and ten-year availability.
7. Identify consumer products: For products intended for or reasonably foreseeably used by non-professional users, enclose the essential safety information on paper.
8. Organise archive and versions: Keep technical documentation and EU DoC for ten years and keep version histories traceable.
9. Involve suppliers and sales: Importers clarify documents with third-country manufacturers; distributors align their verification steps.
10. Plan stock: Units not placed on the market by 19 January 2027 already need the new documentation.

A version you can tick off can be found in the Machinery Regulation checklist.

Which points are still open?

As of October 2026, some questions have not been conclusively clarified:

• Commission guide: The guide to the Machinery Regulation has not yet been published. The Commission has announced it for the fourth quarter of 2026, by 20 January 2027 at the latest; a working group is dealing with digital instructions.
• Questions of interpretation: The “expected lifetime”, the practical meaning of “at the time of purchase” including when the period begins, and the exact scope of “safety information” for consumers are not defined.
• Omnibus IV (digitalisation): A Commission proposal from May 2025 provides, among other things, for the EU DoC to be provided exclusively electronically via link or QR code without login and for the deadlines for paper on request to be reorganised. The Council and Parliament reached a provisional agreement on 9 June 2026. This is a possible future change; as of October 2026, it has not been published in the Official Journal. Until then, the wording of Article 10(7) and (8) quoted here applies.
• Other Member States: Language requirements and penalties outside Germany must be checked in the respective national implementing legislation.

How to implement this with ManualPass

ManualPass supports the documentation part of your roadmap, not the creation of the content. You upload instructions for use, the EU DoC or assembly instructions as a PDF and receive a permanent QR code for each machine type, which does not change when new versions are added. The public scan page allows opening, downloading, saving and printing; old versions remain archived with a SHA-256 checksum. Paper requests are handled via a form with an automatically calculated 30-day deadline and reminder. More under Features and Pricing.

This article reflects the situation as of 04/10/2026 and does not constitute legal advice. The authoritative text is Regulation (EU) 2023/1230 as published in the Official Journal of the EU, together with the national implementing provisions.