CE marking: bills of materials, manuals and instructions for use

The CE mark on a machine is not a quality seal from an authority — it is the manufacturer's own declaration that the product meets all relevant EU safety and health requirements. Behind the small mark lies a whole documentation package and this is where the technical designer comes in: According to the education's competency goals you should be able to prepare technical documentation for CE marking including bills of materials, assembly guides, manuals, instructions for use and safety instructions.

§From directive to regulation

For many years, Machinery Directive 2006/42/EF has set the framework for machinery safety in the EU. It is now being replaced by Machinery Regulation (EU) 2023/1230, which was published in 2023 and should be fully applied from 20 January 2027. A regulation applies directly in all EU countries without national legislation in between, and the new regulation explicitly takes account of newer topics such as cybersecurity, software updates and artificial intelligence in machinery. Until the transition date, manufacturers can continue to follow the directive — after that, the regulation is mandatory.

§Parts of the documentation package

• 01Technical dossier: drawings, calculations, risk assessment, applied standards, and test reports documenting that requirements are met.
• 02EU declaration of conformity: the manufacturer's signed declaration of which legal acts and standards the product complies with.
• 03Instructions for use: assembly, operation, maintenance, residual risks and safety instructions — written so the user in the country where the machine is sold can understand it.
• 04Part lists and spare parts lists: unique identification of each component with item number, designation, quantity and material.
• 05Marking on the machine itself: manufacturer, type designation, serial number, year of manufacture and CE mark.

§The part list — the true companion of the assembly drawing

The part list binds the assembly drawing together with procurement, production and service. Each position on the drawing must be able to be found again in the list with the same number, and the list must be revised together with the drawing — a part list that lags one revision behind is a classic source of incorrect orders. In CAD/PLM systems, the parts list is often generated directly from the 3D model, which makes model quality and correctly filled-in metadata (material, standard designation, supplier number) a prerequisite for a correct list.

§Instructions as a safety document

The instructions are legally part of the machine. It must cover the entire life cycle — transport, assembly, operation, cleaning, maintenance and disposal — and describe the residual risks that the design could not eliminate. As a technical designer you often provide the illustrations, exploded drawings and pictograms that make the instructions unambiguous. A good illustration can replace many lines of text and works across language versions.

“Documentation is not something you do when the machine is finished — it is part of the machine.”

— Basic principle in CE marking work

The practical advice is to build the documentation package in parallel with the construction: create the dossier structure from project start keep the parts list synced with the model and plan the illustrations for the manual while the geometry is still easy to export. That way CE marking becomes a controlled conclusion — not a panic project in the last week.