Machinery Regulation technical documentation and technical file

Start the technical documentation with the product identity, not a generic compliance statement. Article 10 requires the machinery or related product to bear at least the model, series or type, year of construction, and any batch, serial number, or other available identifier. Annex IV Part A then requires a complete description of the machinery or related product and its intended use.

For partly completed machinery, use Annex IV Part B instead. The file should describe the partly completed machinery and the intended function when it is incorporated into or assembled with machinery, other partly completed machinery, or equipment.

The technical file should make the risk logic auditable. Annex IV Part A requires risk-assessment documentation that lists the applicable essential health and safety requirements in Annex III and describes the protective measures implemented for each applicable requirement, including residual risks where appropriate.

Do not leave the EHSR mapping as a spreadsheet of unchecked article references. Each row should connect a hazard or EHSR to the design feature, guard, control function, warning, instruction, validation result, or residual-risk disclosure that supports the claim.

Annex IV expects more than a standards list. The file should state which harmonised standards or Commission common specifications were applied, identify any partial application, and describe other technical specifications used where those standards or specifications were not applied or were only partly applied.

The same section should hold reports or results from design calculations, tests, inspections, and examinations that verify conformity with the applicable EHSRs. For series production, add the internal measures that keep manufactured units aligned with the approved design.

For machinery and related products, Annex IV Part A requires a copy of the instructions for use and the information required by Annex III. Article 10 also requires the product to be accompanied by the EU declaration of conformity or by an internet address or machine-readable code where it can be accessed.

For partly completed machinery, Annex IV Part B requires a copy of the assembly instructions. Article 11 requires the EU declaration of incorporation, or a link or machine-readable code to it, in the assembly instructions.

The Machinery Regulation expressly brings software and data evidence into the technical file where it is needed for safety. Annex IV Part A and Part B include source code or programming logic of safety-related software when a competent national authority makes a reasoned request and the material is necessary to check compliance with Annex III.

For sensor-fed, remotely driven, or autonomous machinery where safety-related operations are controlled by sensor data, Annex IV also calls for a description of the system's general characteristics, capabilities and limitations, data, development, testing, and validation processes where appropriate.

Manufacturers must keep the technical documentation and the EU declaration of conformity available to market-surveillance authorities for at least 10 years after machinery or a related product is placed on the market or put into service. For partly completed machinery, the same 10-year availability rule applies to the technical documentation and EU declaration of incorporation after placing on the market.

If the product category or chosen conformity route involves a notified body, keep the application file, technical documentation submitted, EU type-examination certificate, quality-system approval decisions, audit reports, unit-verification certificates, additions, withdrawals, conditions, and correspondence with the notified body.