[Home](/)/[Resources](/resources)/Technical documentation for CE marking Technical fileCE documentation # Technical Documentation for CE Marking: What You Must Include The CE technical file is the evidence package that justifies your CE mark. It is not submitted for approval—it is retained and presented if authorities request it. This guide covers exactly what must be in the file and how to structure it for audit readiness. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Ftechnical-documentation-for-ce-marking) [Generate technical file template](/platform/start) Free · no account required Problem ## The technical file is evidence, not a folder of PDFs Many hardware teams treat the CE technical file as a dumping ground for test reports, drawings, and manuals. They collect documents as they arrive, drop them in a folder, and assume compliance is handled. This is a mistake. The technical file is not a collection of documents—it is a chain of reasoning. A strong technical file tells a story: this is the product, these are the risks, these laws apply, these standards were used, this evidence supports the claim, and this signed declaration matches the product that actually ships. If the documents in the file describe different product revisions, cite outdated standards, or fail to connect evidence to requirements, the file becomes fragile under scrutiny. The pain point is not collecting the documents. The pain point is structuring them into a coherent evidence package that can survive an audit. This requires planning from the start, not after testing is complete. Requirements ## Required elements of the CE technical file ### Product description and intended use Clear description of what the product is, who it is for, how it works, power source, operating environment, and any variants or accessories. ### Essential requirements analysis Article-by-article mapping showing how your product meets each essential requirement of applicable directives, with evidence references. ### List of harmonised standards Complete list of standards applied, including reference numbers, versions, amendments, and confirmation they are current in the Official Journal. ### Risk assessment Systematic identification of hazards, estimation of risk, implementation of controls, and evaluation of residual risk with verification evidence. ### Test reports Test reports from ILAC MRA-accredited laboratories covering EMC, radio, safety, and any other applicable testing requirements. ### Design and manufacturing records Schematics, PCB layouts, enclosure drawings, BOM, manufacturing instructions, and quality control procedures. ### User instructions and warnings User manual, safety warnings, installation instructions, and any labeling or marking information for the end user. ### Supplier declarations Declarations of conformity, material statements, and component documentation from key suppliers and subcontractors. ### EU Declaration of Conformity Signed declaration listing applicable directives, standards, and conformity assessment procedures used. Process ## Building the technical file as evidence arrives 01 ### Start with the product description Write a clear, detailed description of the product before design freeze. This becomes the anchor for every later decision—directives, standards, risks, tests, and documentation all flow from this description. 02 ### Map directives and standards early Identify applicable directives and select harmonised standards before industrial design locks. Document why each applies and which standards you will use. This prevents last-minute scope changes. 03 ### Run risk assessment in parallel Conduct risk assessment during engineering, not after. Document hazards, controls, and verification evidence. The risk assessment should influence design, warnings, and user manual content. 04 ### Collect evidence as it is created Drop test reports, drawings, supplier declarations, photos, label artwork, and manuals into the file as they are created. Ensure each piece of evidence describes the exact product version that will ship. 05 ### Create the essential requirements matrix Map each essential requirement from applicable directives to the evidence that addresses it. This matrix is the backbone of the file—it shows authorities exactly how you meet each legal requirement. 06 ### Internal review before signing Conduct an internal review of the complete file. Check for version mismatches, missing evidence, outdated standards, and inconsistencies. Only sign the Declaration of Conformity when the file is defensible. Structure ## File structure that survives audit Organize the technical file so authorities can quickly find what they need. A logical structure with clear cross-references makes the file easier to defend. 01. Product identity: description, photos, model numbers, variants, firmware versions 02. Legislation scope: applicable directives and why they apply 03. Standards list: harmonised standards with versions and OJ status 04. Risk assessment: hazards, controls, residual risk, verification 05. Essential requirements matrix: requirement-to-evidence mapping 06. Test evidence: EMC, radio, safety, RoHS, battery, environmental reports 07. Design records: schematics, PCB files, drawings, BOM, manufacturing controls 08. User materials: instructions, warnings, labels, packaging artwork 09. Supplier evidence: declarations, certificates, material statements, datasheets 10. EU Declaration of Conformity: signed, dated, aligned to file content 11. Change control: how future changes trigger compliance review ## Learn this properly, not just for one product In-depth courses and books that teach the process — not a one-off answer you'll need to look up again next time. [Start the course — $149](/courses/01-ce-marking-for-electronics-engineers)[Free roadmap tool](/platform/start) [Prefer to read? Get the book — $24.99](/books/01-ce-marking-for-electronics-engineers) ## Frequently asked questions ### Do I submit the CE technical file to anyone? No. The technical file is compiled and retained by the manufacturer. It is not submitted to any authority for approval. Market surveillance authorities can request it at any time, so it must be available and complete. ### How long must CE technical documentation be kept? For most directives, the technical file and Declaration of Conformity must be retained for 10 years after the last unit is placed on the EU market. Medical devices have a 15-year requirement (30 years for implantables). ### Can technical documentation be electronic? Yes. Electronic documentation is acceptable and increasingly common. However, it must be easily accessible, searchable, and producible on request to authorities. Ensure proper backup and version control. ### What happens if my technical documentation is incomplete? If market surveillance authorities request your file and find it incomplete, inconsistent, or missing key evidence, they may consider your CE mark invalid. This can lead to product recalls, fines, and market bans. [ Map your product, free Every standard, document, and test that applies — free, no account required. Start mapping](/platform/start) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $149](/courses/01-ce-marking-for-electronics-engineers)[Prefer to read? Get the book — $24.99](/books/01-ce-marking-for-electronics-engineers) Related guides * [How to build a CE technical fileComplete guide to building a CE technical file: template structure, required sections, evidence organization, and review-ready …](/guides/how-to-build-ce-technical-file) * [Complete CE documentation bundleA deep guide to the complete CE documentation bundle: Declaration of Conformity, technical file, risk assessment, test evidence…](/guides/complete-ce-documentation-bundle) * [How to create a Declaration of ConformityStep-by-step guide to creating a legally valid EU Declaration of Conformity: required elements, common mistakes, and an example…](/guides/how-to-create-declaration-of-conformity) * [Risk assessment for CEComplete guide to CE risk assessment for hardware products: hazard identification, risk evaluation, control implementation, and…](/guides/risk-assessment-for-ce) Educational resource only. CE responsibility remains with the manufacturer or authorised representative. Verify current law, standards, and product-specific evidence before signing.