Machinery CE Documentation Template

Start the template with the exact product identity. The record should be specific enough that a market surveillance authority, importer, distributor, customer, or notified body can match the documentation to the machinery or related product without relying on project knowledge.

Use a separate scope line for partly completed machinery. Partly completed machinery needs its own technical documentation and declaration of incorporation route instead of being treated as finished CE-marked machinery.

Add a governing-law field: Directive 2006/42/EC before 20 January 2027, or Regulation (EU) 2023/1230 from that date. Article 52 preserves products placed on the market in conformity with the Directive before the cut-off.

Record the actor responsible for each field. Engineering normally supplies design and verification records; safety or regulatory functions control the essential health and safety requirement (EHSR) and route decisions; quality controls production-conformity and document versions; and the manufacturer signs the declaration. An importer verifies the manufacturer's release evidence before placement, but that verification is not a substitute for the manufacturer's file.

The core of the template is an EHSR-by-EHSR matrix. For each applicable essential health and safety requirement in Annex III, record the hazard, risk estimate, design measure, protective measure, information for use, residual risk, verification evidence, and approval status.

For machinery with self-evolving behaviour, software-driven safety functions, autonomous operation, or remote control, include lifecycle hazards that are foreseeable at market placement as an intended evolution of the product's behaviour.

Use the standards table to avoid a common documentation gap: listing a harmonised standard without showing which EHSRs it covers and which clauses were actually applied. Each standard entry should connect to the risk assessment and to test or inspection evidence.

If a harmonised standard or common specification is not fully applied, the template should state the alternative technical specification or engineering justification used to meet the relevant EHSRs.

This section should be a document-control checklist, not a generic evidence list. It should state where each required file is stored, which product version it covers, who approved it, and whether it is ready for authority request, customer review, or notified body submission.

Keep separate tabs for finished machinery and partly completed machinery. Finished machinery records should include EU declaration of conformity and CE marking evidence; partly completed machinery records should include assembly instructions and the EU declaration of incorporation.

The template should force an explicit route decision before release. Annex I Part A products require the specific conformity assessment procedures for that part. Annex I Part B products need a route decision tied to full application of harmonised standards or common specifications, because the notified body route can become necessary when that support is incomplete.

Where a notified body is used, retain the application package, certificate or approval decision, audit or test reports, surveillance records, restrictions, renewals, and marking evidence. For the Article 25(2) and Article 25(3) procedures listed in Article 24(3), put the identification number of the notified body involved in the procedure after the CE marking.