EU Machinery Regulation Checklist

Start with the legal product category, because the documentation set and conformity route change depending on whether the item is machinery, a related product, partly completed machinery, a safety component, or substantially modified machinery. Record the model, intended use, EU role, first placing-on-the-market or putting-into-service event, and whether any exclusion or more specific Union harmonisation legislation covers the relevant risks.

For high-risk routing, check Annex I before choosing the conformity assessment route. Annex I Part A requires one of the Article 25(2) procedures; Annex I Part B allows internal production control only when the product is designed and constructed according to harmonised standards or common specifications covering all relevant EHSRs for that category.

Build the checklist around Annex III, not around a generic project plan. The manufacturer must identify the applicable essential health and safety requirements, carry out risk assessment and risk reduction, and show how the design eliminates hazards or minimises risks.

The record should follow Annex III Part B: determine product limits, intended use and reasonably foreseeable misuse; identify hazards and hazardous situations; estimate severity and probability; decide whether risk reduction is required; and apply protective measures in the required order. For autonomous or self-evolving behaviour, include foreseeable lifecycle hazards arising from that behaviour or logic.

Before release, verify the technical documentation against Annex IV Part A for machinery and related products, or Annex IV Part B for partly completed machinery. The file must explain how the product meets the applicable EHSRs and must be available to market surveillance authorities for at least 10 years after placing on the market or putting into service.

Digital instructions are allowed, but they create specific access, download, print, persistence, and paper-request checks. If safety-related software is relevant, the file should also preserve enough source-code or programming-logic evidence to answer a reasoned authority request when needed to check EHSR compliance.

Choose the Article 25 route only after the scope and Annex I checks are complete. Finished machinery and related products need the relevant conformity assessment procedure, an EU declaration of conformity under Article 21 and Annex V Part A, and CE marking under Articles 23 and 24. Partly completed machinery uses an EU declaration of incorporation under Article 22 and Annex V Part B, not CE marking as finished machinery.

Where a notified body is involved under Article 25(2) or Article 25(3), the checklist should capture the selected module, notified body name and number, certificate or approval reference, production-control evidence, and whether the CE marking must be followed by the notified body's identification number.

Use exact transition facts rather than project shorthand. Regulation (EU) 2023/1230 applies from 20 January 2027, with specific earlier application dates for notification, committee, transitional, delegated-act, and penalty provisions. Directive 2006/42/EC is repealed with effect from 20 January 2027, and products placed on the market in conformity with that Directive before that date may continue to be made available.

Market surveillance evidence should be ready before an authority request. The Regulation requires cooperation with competent national authorities and allows market surveillance authorities to evaluate products presenting risks, require corrective action, and, where needed, drive withdrawal, recall, prohibition, restriction, and safeguard procedures.