EU Machinery Regulation Compliance

Start with the exact product: machinery, a related product, or partly completed machinery. Record whether the item is a safety component, lifting accessory, chain, rope, webbing, removable mechanical transmission device, or another product category covered by the Regulation, and note any more specific Union harmonisation legislation that covers the same risks.

The same scope record should identify the responsible economic operator. A manufacturer placing machinery or a related product on the market or putting it into service carries the design, technical-documentation, conformity-assessment, declaration, and CE marking obligations. Importers and distributors have their own checks before making products available, including documents, instructions, CE marking, and storage or transport conditions.

For machinery and related products, the compliance pack should map hazards and risk-reduction measures to the applicable essential health and safety requirements in Annex III. Keep the risk assessment connected to design choices, safeguards, control systems, warnings, residual risks, test records, and standards used to support conformity.

Where harmonised standards or relevant technical specifications are used, identify the specific clauses and the EHSRs they cover. If a standard is only partly applied, document the gap and the alternative design or test evidence used for the uncovered requirement.

Before placing machinery or a related product on the market or putting it into service, the manufacturer must draw up Annex IV Part A technical documentation and run or have run the relevant Article 25 conformity assessment. For partly completed machinery, use Annex IV Part B technical documentation and an EU declaration of incorporation instead of treating it as finished CE-marked machinery.

The release package should include instructions for use and the information required by Annex III in a language determined by the Member State concerned. Digital instructions are allowed under the Regulation, but the file should show how users access them, which product model they correspond to, and how safety information remains clear, understandable, and legible.

Article 25 routes depend on product category. Annex I Part A products require the specific procedures referred to in Article 25(2). Annex I Part B products use one of the procedures referred to in Article 25(3). Other machinery and related products may use the internal production-control route where the Regulation allows it and the technical documentation supports conformity.

Do not affix CE marking as a generic release step. It follows the completed conformity assessment, the EU declaration of conformity under Article 21, and the CE marking rules in Articles 23 and 24. If a notified body is involved in the production-control phase, record the certificate or approval, notified-body identity, and any required identification-number marking.

The Regulation is explicit that substantial modification can happen by physical or digital means. Treat safety-relevant software, firmware, configuration, remote update, and AI-enabled safety-function changes as compliance triggers when they create a new hazard or increase an existing risk.

Where relevant, technical documentation can include source code or programming logic for safety-related software, and competent national authorities may request it when necessary to check EHSR compliance. Cybersecurity evidence should stay tied to machinery safety: protect safety functions and control systems against corruption or interference that could create hazards.

The Regulation applies from 20 January 2027, and Directive 2006/42/EC is repealed from that date. The transition record should show whether a product was placed on the market before that date under the Directive or is released under the Regulation, without inventing extra grace periods.

After release, keep complaint, incident, non-conformity, corrective-action, withdrawal, recall, and authority-request processes connected to the technical file. Market surveillance authorities can require documents, technical specifications, data, information on compliance, and access to embedded software where necessary for product-compliance assessment.