The EU Machinery Regulation: what to do before January 2027

Which rules apply to your machine?

Before 20 January 2027, machinery placed on the EU market must comply with the Directive. From that date, new placements must comply with the Regulation. Placing on the market means the first supply in the EU for distribution or use; the manufacturing date alone does not decide the applicable rules.

Stock already lawfully placed on the market under the Directive before the deadline can continue to be made available. Keep evidence for each unit: a model’s earlier launch does not establish when every later unit was placed on the market.

Four changes to check first

• Software and connected safety. The Regulation expressly addresses safety-related software, protection against corruption, and control systems. Review remote access and updates alongside mechanical hazards.
• Your conformity route. Annex I Part A requires a notified body. Part B permits internal production control only when qualifying harmonised standards or common specifications cover all relevant requirements. Machines outside Annex I use internal production control. Check your category before booking assessments.
• Digital instructions. Digital manuals have access, download, and retention conditions. Paper copies are required on request at purchase; essential safety information for non-professional users must be on paper.
• Changes to existing machinery. A substantial physical or digital modification can make the modifier responsible as a manufacturer. Screen planned retrofits and software changes against the legal definition.

A practical starting checklist

1. Map the pipeline. List the machines you expect to supply around January 2027, their intended markets, and the evidence supporting each placement date. Include units still held in your own stock.
2. Run one gap review. Pick a representative model. Compare its risk assessment and technical file with Annex III and Annex IV of the Regulation. Record each gap, the person responsible, and a completion date.
3. Confirm the assessment route. Check Annex I and the applicable published standards. If a notified body is needed, confirm its designation for your product and reserve time now.
4. Update the release pack. Prepare the correct declaration, instructions, and traceability records. If you import machinery, ask the supplier for this evidence before shipment. Test any digital manual links as an actual user.

Do you need to start CE marking again?

CE marking, risk assessment, a technical file, and a declaration are already part of the Directive’s system. The task is to check what changes for your product, rather than assume its existing file is sufficient or rebuild everything from scratch.

For an existing machine in use, the changeover alone does not require a new CE assessment. A later substantial modification needs a separate review. Start with your upcoming releases and planned modifications.

Plan your machinery transition with Regunow

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