Obligations of importers and distributors under the Machinery Regulation

Anyone bringing machinery from third countries into the EU has clearly defined obligations under the Machinery Regulation (EU) 2023/1230 from 20 January 2027. Authorities and chambers of commerce usually describe these obligations in a few sentences. This guide shows how you proceed in practice as an importer or distributor – with inspection steps, a checklist and the typical case "manufacturer in China supplies only English instructions".

Importer, distributor or manufacturer – what is your role?

Your obligations depend on the role you play in the supply chain. The Machinery Regulation refers to these roles collectively as "economic operators".

• Importer means anyone who places machinery from a third country on the EU market for the first time. Its obligations are set out in Article 13, and in Article 14 for partly completed machinery.
• Distributor means anyone who makes machinery available in the supply chain without being the manufacturer or importer. Its obligations are set out in Article 15, and in Article 16 for partly completed machinery.
• Manufacturer means anyone who manufactures machinery or has it designed and markets it under its own name. It bears the comprehensive obligations under Articles 10 and 11.

Placing on the market is the first making available of a product on the Union market. According to the prevailing interpretation, what counts is the individual unit, not the model. Machinery placed on the market for the first time from 20 January 2027 must therefore comply with the Regulation – even if the type has been built for years.

When do importers and distributors become manufacturers themselves?

The most important distinction is made in Article 17. Anyone who overlooks it fulfils the wrong obligations.

Typical cases from practice:

• Own brand (private label): you have a machine manufactured in the Far East and sell it under your company name. You are then the manufacturer – with conformity assessment, technical documentation, EU declaration of conformity and instructions for use under your own responsibility.
• Modification before sale: you change the control system, safeguards or software in a way that may affect conformity. In that case, too, you are considered the manufacturer.
• Substantial modification: regardless of role, under Article 18 any person who substantially modifies machinery is considered the manufacturer. This expressly includes digital modifications.

What obligations do importers have under Article 13?

For importers, four obligations from Article 13 are particularly relevant:

The EU declaration of conformity is the document in which the manufacturer declares that the machinery meets the requirements of the Regulation. It may be supplied with the product or made accessible via an internet address or a machine-readable code in the instructions for use (Article 10(8)). Details can be found in the guide Digital EU declaration of conformity.

What must be checked before placing on the market? The checklist

The following checklist translates Article 13 into concrete inspection steps. Work through it for each machine type and document the result with date and name.

Role and basics

• Role clarified: importer, distributor or manufacturer under Article 17 (own brand, modification)?
• Manufacturer stated on the machinery with name, postal address and a digital means of contact (Article 10(6))?
• Own importer contact details added, including website or email (Article 13(3))?

Conformity

• CE marking affixed to the machinery?
• Manufacturer has confirmed that the technical documentation has been drawn up and can be submitted at the authority's request?
• EU declaration of conformity available, naming the correct model and Regulation (EU) 2023/1230?
• EU declaration of conformity available in the language of the destination country – in Germany, in German (Section 2 MaschinenDG)?

Instructions for use

• Instructions for use clearly describe the product model?
• Instructions in the language determined by the destination country – in Germany, in German?
• For digital instructions: access information on the machinery, only alternatively on the packaging or an accompanying document (Article 10(7), second subparagraph, point (a))?
• PDF can be printed, downloaded and saved (point (b))?
• Online availability for the lifetime, at least ten years, is organised (point (c))?
• Process for paper copies on request within one month defined?
• For consumer products: essential safety information supplied in paper format?

Evidence

• EU declaration of conformity and inspection record filed for ten years (Article 13(8))?

Case: manufacturer in China supplies only English instructions

This is the most common case in practice. A manufacturer from a third country supplies English instructions for use, perhaps as a PDF by email or as a link to its website.

For the German market, this is not sufficient. Under Section 2 MaschinenDG, the instructions for use, safety information and EU declaration of conformity must be "drawn up in German". If the German instructions are missing, a fine of up to €10,000 may be imposed under Section 9(1) no. 4 and (2) MaschinenDG, in addition to official measures.

How to proceed:

1. Request a German version. Ask the manufacturer whether it supplies German instructions and who is responsible for their accuracy.
2. Commission the translation yourself if the manufacturer does not supply one. Have the translation checked by a subject-matter expert, ideally against the machine.
3. Compare the content. Check whether the model designation, warnings and technical data match the version supplied.
4. Clarify provision. Determine where the German version is kept online and who keeps it available for at least ten years.

Further information on translation and multilingual markets can be found in the guide Language of the instructions for use.

Who provides the digital instructions if the manufacturer is based in a third country?

Legally, responsibility is split in two. Under Article 10(7), the manufacturer ensures that the instructions for use are supplied and may provide them digitally. Under Article 13(4), the importer must ensure that the instructions and information under Article 10(7) are supplied.

The Regulation does not expressly govern how this is to be divided in detail for digital instructions. The Commission's guide to the Machinery Regulation has not yet been published. This point is therefore open to interpretation.

In practice, there is much to be said for the importer organising the provision of the German version itself:

• The website of a third-country manufacturer is not always reliably accessible from Europe and can change at any time.
• This way, you control that the right language version belongs to the right machine.
• Paper requests from German customers usually end up with the importer anyway.

The requirements remain the same: access information, a format that can be printed, downloaded and saved, online availability for the lifetime and at least ten years. How to secure the ten-year period even through website relaunches is explained in the guide Instructions for use: 10 years. The process for paper requests is described in Paper copy on request.

What obligations do distributors have under Article 15?

Distributors check less thoroughly than importers, but they do check. Before making machinery available, under Article 15(2) they verify that:

"[…] the instructions for use and information referred to in Article 10(7) [are supplied] in a language which can be easily understood by users."

They also check the CE marking and the EU declaration of conformity "in accordance with Article 10(8)". For distributors of partly completed machinery, Article 16 applies, with the assembly instructions and the declaration of incorporation.

In practice, this means: incoming goods with a brief check. Check on a sample basis whether the QR code or link works and the German version is actually accessible.

What happens if the check reveals deficiencies?

If you find during the check that documents are missing or the machinery does not comply, you may not place it on the market or make it available until conformity has been established (Article 13(2), Article 15(3)). Request missing documents from the manufacturer and document the process.

In Germany, the MaschinenDG imposes significant penalties here. If an importer places a non-compliant product on the market (Section 9(1) no. 16) or a distributor makes it available (no. 17), fines of up to €100,000 are possible. The same applies to failure to take corrective action (no. 7). In cases of persistent repetition or danger to life and health, a criminal offence may exist under Section 10.

For documentation infringements such as missing German instructions, by contrast, the range of up to €10,000 per infringement applies.

Possible changes through Omnibus IV

With Omnibus IV (digitalisation), the EU is negotiating a possible future amendment of Article 10(7) and (8). The Council and Parliament reached a provisional agreement on 9 June 2026. As of October 2026, the amendment has not been published in the Official Journal. Until then, the law in force as described above remains decisive.

How to implement this with ManualPass

ManualPass is a platform on which importers and distributors upload instructions for use, EU declarations of conformity and safety information as PDFs and provide them digitally. You provide the German version, which you draw up or have translated, there for each machine type under a permanent QR code. New versions appear automatically, without a new label, and older versions remain archived.

Paper requests from customers are handled via a form with an automatically calculated deadline and evidence in the log. ManualPass does not create or translate instructions. An overview for your target group can be found under ManualPass for importers, and the plans under 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.