From the Machinery Directive to the Machinery Regulation – what changes for documentation?

The Machinery Directive 2006/42/EC will be replaced by the Machinery Regulation 2023/1230 on 20 January 2027. Many overviews cover safety requirements, AI and conformity assessment. This article focuses on one point that affects every manufacturer, importer and distributor: documentation. What changes for instructions for use, the declaration of conformity and archiving – and what stays as it is?

Directive or Regulation – what is the legal difference?

An EU directive is a legal act that only takes effect through national laws in the Member States. In Germany, the Machinery Directive was transposed by the 9th Product Safety Ordinance (9. ProdSV, "Maschinenverordnung"). An EU regulation, by contrast, applies directly in all Member States, without a transposing law.

For you, this means: from 2027, you read the obligations directly in the EU text. National laws only govern accompanying matters such as language and fines. In Germany, this is the Machinery Regulation Implementation Act (MaschinenDG). According to the draft bill, the 9. ProdSV ceases to have effect "at the end of 19 January 2027" (BT-Drs. 21/1507, Article 2).

The differences in documentation at a glance

The following table compares the provisions relevant to documentation. Unless stated otherwise, references are to Regulation (EU) 2023/1230.

What applied to digital instructions for use under the Directive?

The text of Directive 2006/42/EC did not provide for a digital format in Annex I, section 1.7.4. With edition 2.3 of the Guide to the Machinery Directive (April 2024), the Commission amended §§ 255 and 261. Since then, digital instructions for use and the digital EC declaration of conformity have been accepted under conditions that correspond to those of the Regulation: access information, a format that can be printed and saved, 10 years of availability, paper free of charge within one month, safety information on paper for consumers.

The difference lies in how binding the rules are. A guide is an interpretative aid, not law. The Regulation lays down the rules in its enacting terms, namely Article 10(7). Annex III, Part B, section 1.7.4 refers to this expressly: in addition to the obligations set out in Article 10(7), the instructions for use are to be drawn up as set out in that section.

"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."

Original instructions and language

The Directive distinguished between "original instructions" and "translation of the original instructions". Based on our review, this term no longer appears in section 1.7.4 of the Regulation. You should verify this statement against the EUR-Lex text before changing your labelling.

What matters now is the language determined by the Member State concerned. Germany requires the instructions for use, the safety information and the EU declaration of conformity to be drawn up "in German" (Section 2 MaschinenDG). More on this in the guide Language of the instructions for use.

New obligations for economic operators

Economic operators are all those who manufacture, import or distribute machinery. The Regulation describes their obligations in more detail than the Directive.

• Importers check the technical documentation, CE marking and accompanying documents, state their own contact details including a digital means of contact, and keep the EU DoC available for 10 years (Article 13).
• Distributors verify, before making the product available, the CE marking, the EU DoC and whether the instructions for use and information under Article 10(7) are supplied "in a language which can be easily understood by users" (Article 15(2)).
• Importers or distributors as manufacturers: anyone who places a product on the market under their own name or modifies it in a way relevant to conformity is considered the manufacturer (Article 17).
• Substantial modification: a substantial modification is a physical or digital modification not foreseen by the manufacturer that makes new protective measures necessary (Article 3, point (16)). Anyone who carries it out is considered the manufacturer (Article 18) – except non-professional users for their own use.

Importers will find it worth reading the guide Obligations of importers and distributors.

What applies to machinery placed on the market before 2027?

Placing on the market is the first making available of a product on the EU market. What matters is the individual unit, not the model.

"[…] placed on the market in accordance with Directive 2006/42/EC before 20 January 2027."

Member States may not impede the making available of such products. In our interpretation, this means:

• A unit placed on the market under the Directive up to and including 19 January 2027 may continue to be traded – with the previous documentation.
• A unit placed on the market for the first time from 20 January 2027 must comply with the Regulation. This also applies if the model has been built unchanged for years.
• There is no sell-off period for stock that has not yet been placed on the market.
• EC type-examination certificates under Article 12 of the Directive "remain valid until their expiry" (Article 52).

Do I need a new declaration of conformity?

Yes, for all units from 20 January 2027. The EU declaration of conformity follows Article 21 and the model in Annex V, Part A. It must be kept up to date and translated into the language required by the Member State (Article 21(2)). If your machinery falls under several EU legal acts, you issue only one declaration (Article 21(3)).

What is new is the choice between supplying and linking. Instead of supplying the EU DoC, you can state the internet address or a machine-readable code in the instructions for use (Article 10(8)). The digital declaration must then remain online for the expected lifetime, at least ten years after placing on the market or putting into service (Article 10(8), second subparagraph). Details in the guide Providing the EU declaration of conformity digitally.

What stays the same?

For all the restructuring, the basic principle of documentation does not change:

• Every machine comes with instructions for use – on paper or, subject to conditions, digitally.
• The manufacturer draws up technical documentation and issues a declaration of conformity.
• CE marking remains the visible conformity mark.
• The instructions must clearly describe the product model and state residual risks (Annex III, Part B, section 1.7.4.2).
• The instructions must be in a language that can be easily understood by users.
• For most machinery, internal production control (Module A) remains the conformity assessment procedure (Article 25). A notified body is mandatory only for the six categories in Annex I, Part A.

Outlook: possible further change through Omnibus IV

The Commission's "Omnibus IV" proposal (digitalisation, 2025/0134(COD)) would amend Article 10(7) and (8) again, for example with a "digital by default" principle. The Council and Parliament reached a provisional agreement on 9 June 2026. This is a possible future change that, as of October 2026, has not been published in the Official Journal. Plan on the basis of the text currently in force.

The Commission's guide to the Machinery Regulation is also still outstanding. It has not yet been published and is announced for Q4 2026, by 20 January 2027 at the latest.

How to implement this with ManualPass

ManualPass provides your existing PDF documents: instructions for use, EU declaration of conformity, assembly instructions. For each machine type you receive a permanent QR code that never changes. New versions – such as the EU DoC under the Regulation from 2027 – appear automatically, while every older version remains archived unchanged and accessible. How this works is shown on the page Archiving and versioning. You will find the plans under Pricing.

A complete task list up to the deadline is available in our Machinery Regulation checklist.

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.