The date to put in your planning system is 20 January 2027. Regulation (EU) 2023/1230 generally applies from then, replacing the Machinery Directive 2006/42/EC.
For an OEM, the preparation starts with products and market-placement dates. A quotation date or a booked shipment does not, by itself, settle which rules apply. Check the intended placement on the market or putting into service, the product’s scope, and the applicable transition provisions. Articles 51–54 of the current regulation.
Documentation is a substantial part of this work. Here is a practical way to organize it without treating a new manual template as the whole compliance project.
This guide focuses on machinery and related products covered by Article 10. If you supply partly completed machinery, Article 11 applies: technical documentation under Annex IV, Part B, assembly instructions under Annex XI, and an EU declaration of incorporation. Check that route separately, including its digital-delivery conditions.
Separate the customer documents from the evidence file
Customer instructions explain how to install, operate, maintain, and otherwise use the machinery as required. Technical documentation supports the assessment of conformity. The declaration records the manufacturer’s conformity statement.
They are related, but they are not interchangeable. A customer portal does not automatically constitute a complete technical file, and the technical file does not automatically provide usable customer instructions.
Assign an owner to each deliverable and record the machine or configuration it covers. Then identify the information shared between them.
Review the technical documentation against Annex IV
Article 10 and Annex IV, Part A address the manufacturer’s technical documentation. The required material includes the machinery description, risk-assessment documentation, relevant drawings and explanations, applicable specifications, calculations and test evidence, and a copy of the instructions.
The exact content depends on the machinery. Some software-related and autonomous capabilities introduce additional matters to document and assess. Use the regulation’s requirements to build your gap list rather than assuming every previous technical file needs the same changes.
For each required item, record its source, responsible person, revision, and review status. A link to an unavailable engineer’s working folder is a dependency to resolve before release.
Make digital instructions an operational decision
Article 10(7) explicitly permits digital instructions subject to conditions. The manufacturer must mark how to access them on the machinery or related product. Only where that is not possible may the access information appear on the packaging or in an accompanying document.
Users must be able to download, save, and print the instructions so they can access them even during a breakdown. The instructions must remain available online throughout the expected lifetime, with a minimum of ten years after market placement. If the user requests a paper copy at purchase, the manufacturer must supply it free of charge within one month.
Essential safety information must also be supplied on paper for machinery intended for, or foreseeably usable by, non-professional users.
Instructions for use, safety information, and the information required by Annex III must be clear, understandable, and legible, in a language easily understood by users as determined by the Member State concerned.
Decide who owns the access labels, stable URLs, hosting, exports, language releases, and paper requests. Test these arrangements with an actual documentation set. A PDF hosted on a website can meet the digital-delivery requirements if the instructions and delivery arrangements satisfy these conditions.
Keep the declaration and retention duties distinct
Article 10(8) provides for an EU declaration of conformity accompanying the machinery or access through an internet address or machine-readable code given in the instructions and the information required by Annex III. A digital declaration must remain accessible online throughout the expected lifetime of the machinery or related product, and for at least ten years after placing on the market or putting into service.
This online-access obligation is separate from the retention of technical documentation for authorities.
Under Article 10(3), manufacturers must keep the technical documentation and EU declaration available to market surveillance authorities for at least ten years after placing on the market or putting into service.
Build a retention plan around those obligations. Records of revisions and approvals help you operate it, but the existence of an audit log is not a legal conclusion about conformity.
Bring engineering changes into the review
A change to guarding, control software, intended use, or a component may affect several documents. Establish how the change reaches the person responsible for the risk assessment and how resulting instructions reach the affected users.
Substantial modification is also addressed in the regulation. Its definition and consequences require a product-specific assessment; not every repair or software update is automatically a substantial modification.
Avoid replacing every historical machine record with the newest design. Preserve what was released and assess subsequent changes against the actual configuration.
Run a readiness check on one representative machine
Select a machine expected to fall under the new rules. Walk through its scope decision, technical documentation, risk assessment, instructions, declaration, and delivery method. Record unresolved questions and accountable owners.
Soply can support the documentation workflow. The manufacturer remains responsible for the machinery’s conformity and the adequacy of its evidence.
Book a documentation demo with one representative machine and your existing files. Use the result to inform a wider readiness plan.
This article is general information based on the consolidated regulation checked in September 2026. Confirm the requirements and assessment route for your specific products.
