Which documents fall under EU Machinery Regulation 2027: a plain-language guide for documentation teams

Which documents fall under EU Machinery Regulation 2027: a plain-language guide for documentation teams

Regulation (EU) 2023/1230 replaces the old Machinery Directive (2006/42/EC

on 14 January 2027. If your company designs, manufactures, imports, or distributes machinery or related products for the EU market, your documentation team is at the centre of compliance. This guide breaks down exactly which documents the regulation requires, who is responsible for each, and what has changed since the old directive.

What the regulation actually covers

Before diving into documents, it helps to know which products the regulation covers, because this shapes every documentation obligation that follows.

EU Machinery Regulation 2023/1230 applies to:

• Machinery - assemblies of linked, moving parts fitted with a drive system (or missing only the components to connect to one), including machinery that is missing only the upload of its intended software
• Interchangeable equipment - devices assembled by the operator to change or extend a machine's function
• Safety components - physical or digital components (including software) that serve a safety function and are independently placed on the market
• Lifting accessories - slings, hooks, and similar components placed between the machine and the load
• Chains, ropes, and webbing - designed and constructed for lifting purposes
• Removable mechanical transmission devices
• Partly completed machinery - assemblies not yet capable of performing a specific application on their own

The regulation does not apply to weapons and firearms, motor vehicles covered by their own EU type-approval regulations, seagoing vessels, machinery for military or police purposes, mine winding gear, and a defined list of low-voltage electrical equipment such as household appliances and electric motors.

One important addition compared to the old directive: software that independently fulfils a safety function is now explicitly classified as a safety component, and therefore falls within scope. This is new territory for many documentation teams.

The seven core documents your team must produce

Every product within scope of the regulation triggers a set of mandatory documents. Here is what each one is, who must produce it, and how long it must be kept.

1. Technical documentation (Annex IV, Part A)

This is the master file that proves your product complies with the essential health and safety requirements in Annex III. It is not a single document, it is a structured package of evidence that must include at minimum:

• A complete description of the machinery or related product and its intended use
• Risk assessment documentation, including a list of applicable essential health and safety requirements, the protective measures implemented, and any residual risks
• Design and manufacturing drawings and circuit diagrams
• Descriptions and explanations needed to understand the drawings and the product's operation
• References to harmonized standards applied, or if not applied, the alternative technical specifications used
• Reports and results of design calculations, tests, inspections, and examinations
• A description of how series production will maintain conformity
• A copy of the instructions for use
• Where relevant, the source code or programming logic of safety-related software (available to national authorities on reasoned request)
• For sensor-fed, remotely-driven, or autonomous products: a description of the system characteristics, data processes, and validation methods used

Who keeps it: The manufacturer.

How long: At least 10 years after the product is placed on the market or put into service.

A key change from the old directive: The regulation now explicitly requires documentation of software-related safety logic, and for AI-driven or autonomous machinery, a description of the system's capabilities, data dependencies, and testing methodology. This is a genuinely new documentation burden for teams working with smart or connected products.

2. EU declaration of conformity (Article 21, Annex V Part A)

This is the formal statement in which the manufacturer declares that the product meets all applicable essential health and safety requirements. It must follow the model structure in Annex V and contain:

• The manufacturer's name, registered trade name or mark, postal address, website, and digital contact details
• Product identification (model, type, serial number, year of construction)
• A statement that the product meets all applicable requirements of the regulation
• Where applicable, the name and identification number of the notified body involved in conformity assessment
• References to harmonized standards applied
• Place, date, and the identity and signature of the authorized person

The EU declaration of conformity must accompany the product, or the manufacturer may instead provide a URL or machine-readable code in the instructions for use pointing to the online declaration. If provided digitally, it must remain accessible for the expected lifetime of the product and for at least 10 years.

A practical note for documentation teams: The regulation explicitly allows a single consolidated EU declaration of conformity to cover multiple Union legal acts that apply to the same product. This is a simplification worth taking advantage of.

3. Instructions for use (Annex III, section 1.7.4)

Instructions for use are required for every product within scope. They must be in a language easily understood by users, as determined by the Member State where the product is placed on the market.

The regulation sets out a detailed list of what instructions must cover, including: the manufacturer's full contact details; a general description of the product; drawings and diagrams for use, maintenance, and repair; a description of workstations; intended use; warnings about foreseeable misuse; assembly and installation instructions; noise and vibration data; residual risk information; maintenance schedules; spare parts specifications; and, for relevant products, information on hazardous substance emissions.

New in 2023/1230: Instructions may be provided in digital format (online or embedded in the product), but with conditions:

• The product must bear instructions or a code explaining how to access the digital version
• The format must allow the user to print, download, and save the instructions
• The digital version must remain accessible online for the expected lifetime of the product and for at least 10 years after placing on the market
• At the time of purchase, any user may request a paper copy and the manufacturer must provide it free of charge within one month
• For products intended for (or foreseeably used by) non-professional users, essential safety information must still be provided in paper format

This digital-first shift has significant implications for how documentation teams manage, host, and version-control their content. A broken URL two years after product launch is now a compliance failure, not just a customer service issue.

4. EU declaration of incorporation (Article 22, Annex V Part B) for partly completed machinery

If your product is partly completed machinery, you do not issue an EU declaration of conformity. Instead, you issue an EU declaration of incorporation, stating which essential health and safety requirements have been applied and fulfilled, and that the product must not be put into service until the final machinery it is incorporated into has been declared conformant.

This declaration must be continuously updated and translated into the language required by the Member State in which the partly completed machinery is incorporated.

Who keeps it: The manufacturer of the partly completed machinery, for at least 10 years.

5. Assembly instructions (Annex XI) for partly completed machinery

Partly completed machinery must also be accompanied by assembly instructions describing the conditions that must be met for correct incorporation into the final machinery without compromising safety. These must be in a language easily understood by the person who will perform the incorporation.

6. Technical documentation for partly completed machinery (Annex IV, Part B)

Similar in structure to Annex IV Part A, but scoped to partly completed machinery. It must cover the design and construction of the partly completed machinery to the extent necessary to demonstrate conformity with the essential health and safety requirements that apply at this stage.

7. Product marking information

This is not a separate document but a marking obligation that documentation teams often manage. Every product must bear at minimum: the manufacturer's name, registered trade name or mark, postal address, website, and digital contact details; the product model, series or type; year of construction; and a batch or serial number (or equivalent identification element). CE marking is also required for machinery and related products, affixed visibly, legibly, and indelibly before placing on the market.

Who is responsible for which documents

The regulation creates obligations for multiple parties in the supply chain:

Manufacturers carry the primary documentation burden: they must prepare the technical documentation, draw up the EU declaration of conformity or incorporation, produce the instructions for use, and keep documentation available to market surveillance authorities for at least 10 years.

Importers must verify that the manufacturer has carried out the required conformity assessment, that the CE marking is affixed, and that the technical documentation has been drawn up. They must also ensure the product is accompanied by instructions for use and that contact details are in a language easily understood by users.

Distributors must verify, before making a product available, that it bears the CE marking, is accompanied by the required documents, and that the manufacturer and importer have complied with their obligations. Contact details on the product or documentation must be in a language easily understood by users.

What changed from the old directive

Documentation teams familiar with Directive 2006/42/EC will notice several significant shifts:

Software and digital safety components are now explicitly in scope. Safety software placed independently on the market is a safety component under the regulation. Its technical documentation requirements are the same as physical safety components, including, on request from national authorities, the source code or programming logic.

AI and autonomous machinery require additional documentation. For sensor-fed, remotely driven, or autonomous products, the technical documentation must describe the general characteristics, capabilities, and limitations of the system; data, development, testing, and validation processes. This is entirely new.

Digital instructions are now a primary delivery channel, not an alternative reserved for special cases. But the obligations around accessibility, longevity, and paper-on-request are also new compliance tasks.

The EU declaration of conformity can be delivered via URL or QR code, rather than requiring a physical document in the box. However, the manufacturer remains responsible for keeping that link live.

Cybersecurity is now a concern for machinery. The regulation requires manufacturers to adopt proportionate measures to protect the safety of the product against malicious third-party interference. This may require documentation of security architecture as part of the technical file.

The language question: why translation is never optional

Every mandatory document under this regulation carries a language requirement. Instructions for use must be in a language easily understood by users, as determined by the Member State in which the product is placed on the market. The EU declaration of conformity must be translated into the language or languages required by the relevant Member State. Assembly instructions must be in a language understood by the person doing the incorporation.

For manufacturers selling across multiple EU markets, this means systematic multilingual documentation management is a compliance requirement, not a customer service preference. Managing 24 or more language versions of a technical file, instruction manual, and declaration of conformity (and keeping them synchronized as products evolve) is a significant operational challenge.

This is where a translation management platform like TextUnited becomes operationally relevant. TextUnited allows manufacturers and documentation teams to manage the full translation lifecycle for regulatory documents: creating translation memories specific to product lines, maintaining consistency across versions and markets, automating workflows between engineers, technical writers, and translators, and producing audit-ready records of what was translated and when. When a safety instruction changes in the source language, a properly configured workflow ensures every language version is updated in step; which is exactly what "keeping the technical documentation at the disposal of market surveillance authorities" requires in practice.

What documentation teams should do now

The regulation applies from 14 January 2027. Products placed on the market in conformity with Directive 2006/42/EC before that date can remain on the market. But for any product first placed on the market on or after 14 January 2027, the new requirements apply in full.

For documentation teams, the practical steps are:

Review your current technical file templates against the Annex IV Part A requirements, particularly the new requirements for software-related safety logic and autonomous systems. Assess whether your instructions for use content and delivery infrastructure is capable of meeting the digital access obligations, hosting, longevity, and paper-on-request. Map your translation workflows to the language requirements for each target market, and check whether your current process can maintain synchronization across language versions when source documents change. For partly completed machinery, confirm that your Annex IV Part B templates and assembly instruction formats are updated to the 2023/1230 structure.

This article is based on Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery (OJ L 165, 29.6.2023).

It is intended as a plain-language orientation guide and does not constitute legal advice. Consult the full regulation text and qualified legal counsel for compliance decisions.