# Machine CE Marking Technical File Checklist > Source: https://netray.co/tools/machine-ce-marking-technical-file-checklist > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer Checklist of the documents and evidence a machine builder collects in the technical file under the EU Machinery Directive 2006/42/EC before CE marking. ## Category compliance-legal ## Region European Union ## Industry Industrial Machinery ## Audience - Compliance engineer - OEM engineering manager - Safety engineer - Machine builder ## Tool **Kind:** checklist **Scoring Note:** This is a working aid, not legal advice. Machinery Directive 2006/42/EC applies until the Machinery Regulation (EU) 2023/1230 applies from 20 January 2027. Confirm the applicable route with your notified body or counsel. **Groups:** #### Scope and conformity route **Items:** **Text:** Machine is confirmed as machinery within the scope of the directive **Critical:** true **Text:** Applicable directives are listed, such as low voltage, EMC and radio equipment where relevant **Critical:** true **Text:** Check whether the machine is on the Annex IV list and needs a notified body route **Critical:** true Harmonised standards used are identified with edition and date Manufacturer or authorised representative in the EU is named Machine identification, type and serial numbering rules are defined #### Design and risk documentation **Items:** **Text:** General description and intended use are written down **Critical:** true Reasonably foreseeable misuse is recorded **Text:** Risk assessment covers all lifecycle phases, including setup, maintenance and cleaning **Critical:** true **Text:** Hazards are mapped to protective measures and residual risk is stated **Critical:** true Overall assembly drawing and key subassembly drawings are filed Control circuit diagrams are filed Calculations and test results supporting safety are filed #### Safety functions and verification **Items:** **Text:** Safety functions are listed with required performance level or SIL **Critical:** true **Text:** Safety function verification and validation reports are filed **Critical:** true Emergency stop and guard interlock design is documented Electrical equipment is checked against the relevant machinery electrical standard Noise, vibration or radiation measurements are filed where relevant Hydraulic and pneumatic safety elements are documented Software safety validation is documented where safety software is used #### Components and suppliers **Items:** Safety components carry their own CE declarations or certificates Incomplete machinery supplied by others has declarations of incorporation Third party test reports are filed with dates and scope Supplier datasheets for safety relays, PLCs, drives and sensors are retained Bill of materials is linked to the as-built revision #### Instructions and marking **Items:** **Text:** Instructions are provided in the languages required for the destination **Critical:** true Instructions cover installation, use, maintenance, residual risk and decommissioning Warning signs and pictograms are fitted and match the instructions **Text:** Machine nameplate carries name and address, designation, series or type, year of construction and CE mark **Critical:** true Instructions for safe lifting and transport are included #### Declaration and retention **Items:** **Text:** EU declaration of conformity is drafted and signed by an authorised person **Critical:** true Declaration lists the machine, standards, notified body if any, and signatory **Text:** Technical file is retained for at least ten years after the last unit is made **Critical:** true Process exists to update the file after design or standards changes File can be provided to authorities within a reasonable time ## Content **Intro:** Before a machine can carry the CE mark in the EU, the builder must assemble a technical file that shows how the safety requirements were met. This checklist lists the documents and evidence that normally belong in that file. **Sections:** #### How to use this checklist **Body:** Work through the groups in order. Start with scope, because every later step depends on whether your machine is in scope and which conformity route applies. Then build the risk assessment, which is the spine of the file, and link each hazard to a protective measure and to evidence that the measure works. Tick items as they are filed, and record where each document lives so the file can be produced quickly. The critical items are the ones authorities and customers usually ask for first. **Bullets:** - Keep one master index with document numbers and revisions. - Store the file against the machine type and as-built revision. - Update the file after any design change that affects safety. - Keep translations controlled with the source instructions. #### What the technical file is **Body:** Under the Machinery Directive 2006/42/EC, the technical file is the set of documentation the manufacturer must hold to demonstrate conformity. It is not sent with the machine; it is available to market surveillance authorities on request. The customer receives the instructions and the declaration of conformity instead. Annex VII of the directive sets out its contents. Machines listed in Annex IV have extra conformity assessment requirements, which can include a notified body, so check that first. #### Risk assessment and verification **Body:** A strong file connects three things: the hazard, the protective measure and the verification. For safety functions implemented in control systems, record the required performance level, the architecture, diagnostic coverage and the calculation or tool report, plus the validation test that proved it on the actual machine. Reviewers look for traces from each hazard to a test result. A risk assessment that is a generic table with no link to the design is the most common weak point. #### Common mistakes and the new regulation **Body:** Common mistakes include missing instructions in the destination language, declarations that cite withdrawn standards, and files that describe the design as proposed rather than as built. Teams also forget that components integrated from other suppliers need their own paperwork. The Machinery Regulation (EU) 2023/1230 replaces the directive with application from January 2027 and adds points on software, cybersecurity and AI-enabled safety functions. Start mapping your file to it now if your machines will be sold after that date. **Cta:** If your engineering data, BOM revisions and compliance documents live in different systems, Netray can help link them so the technical file stays current with the as-built configuration. **Faq:** #### Does the technical file go to the customer? **Answer:** No. The customer receives the instructions and the EU declaration of conformity. The technical file stays with the manufacturer and is made available to market surveillance authorities on a reasoned request. Some customers ask to audit it during supplier qualification, which is a commercial arrangement. #### How long must the technical file be kept? **Answer:** For ten years after the last machine of that type has been manufactured under the Machinery Directive. Keep all versions that relate to units placed on the market, along with the standards editions applied, so you can show what was true at the time of supply. #### Do I need a notified body? **Answer:** Only for machines in Annex IV where harmonised standards are not fully applied, or for certain categories. Most machines follow internal production control. Check the Annex IV list and the standards you used early, because a notified body route changes schedule and cost. #### Is this checklist enough to CE mark a machine? **Answer:** No. It is a working aid listing typical contents. You still need competent engineering, correct standards, a real risk assessment and test evidence. Confirm your obligations with a qualified safety engineer, notified body or legal adviser for your specific machine and market. ## Search terms CE marking technical file checklist, machinery directive technical file, machine CE technical documentation, 2006/42/EC technical file contents, CE marking machine builder checklist, declaration of conformity machinery, machine technical construction file, CE file template machinery --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json