--- title: "Technical Documentation (Technical File)" canonical_url: "https://www.sorena.io/artifacts/eu/low-voltage-directive/technical-documentation" source_url: "https://www.sorena.io/artifacts/eu/low-voltage-directive/technical-documentation" author: "Sorena AI" description: "Build an audit-ready LVD technical file for Directive 2014/35/EU: Annex III elements (product description, drawings/schematics, explanations, standards list." published_at: "2026-02-21" updated_at: "2026-02-21" keywords: - "LVD technical documentation" - "LVD technical file Annex III" - "Directive 2014/35/EU Annex III checklist" - "CE marking technical file electrical equipment" - "LVD test reports requirements" - "EU declaration of conformity retention 10 years" - "technical documentation" - "technical file" - "Annex III" - "CE marking" - "evidence" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # Technical Documentation (Technical File) Build an audit-ready LVD technical file for Directive 2014/35/EU: Annex III elements (product description, drawings/schematics, explanations, standards list. *Technical File* *EU* ## EU LVD 2014/35/EU Technical Documentation A technical file structure you can hand to market surveillance in minutes. Focus: Annex III checklist + evidence indexing + retention and change control. Under the LVD, technical documentation is the core conformity artifact. Annex III is explicit that the file must make it possible to assess conformity and include an adequate analysis and assessment of risks. A good file is therefore not a dump of PDFs. It is a navigable evidence system that connects Annex I objectives, standards choices, tests, and released product configurations. ## 1) What the technical documentation must achieve A reviewer should be able to move quickly from product identity to hazard reasoning to evidence. If that path is not obvious, the file is incomplete even if the documents technically exist. Think of the technical file as the source of truth that supports the DoC, CE marking, importer support, and corrective action. - Clear product identity, variants, photos, labels, and traceability logic. - Explicit connection from Annex I objective to hazard, control, test method, and result. - A change history that explains why the current DoC is still valid. *Recommended next step* *Placement: after the template, evidence, or documentation block* ## Keep EU LVD 2014/35/EU Technical Documentation in one governed evidence system SSOT can take EU LVD 2014/35/EU Technical Documentation from reusing this material inside a governed evidence system to a reusable workflow inside Sorena. Teams working on EU LVD 2014/35/EU can keep owners, evidence, and next steps aligned without copying this guide into separate documents. - [Open SSOT for EU LVD 2014/35/EU Technical Documentation](/solutions/ssot.md): Start from EU LVD 2014/35/EU Technical Documentation and keep documents, evidence, and control records in one governed system. - [Talk through EU LVD 2014/35/EU](/contact.md): Review your current process, evidence gaps, and next steps for EU LVD 2014/35/EU Technical Documentation. ## 2) Annex III minimum contents Annex III gives you the minimum schema for the file. Use it as the index, then attach additional documents where needed. Do not forget the risk analysis requirement hidden in the opening sentence of Annex III. - General description of the electrical equipment. - Design and manufacturing drawings, schemes of components, sub assemblies, circuits, and explanations needed to understand them. - Standards list showing what was applied in full or in part, plus alternative solutions where needed. - Results of design calculations, examinations, and test reports, supported by an adequate analysis and assessment of risks. ## 3) Standards and presumption of conformity inside the file The standards register inside the technical file should show the decision references, editions, and whether a standard is fully applied, partially applied, or only used as supporting material. This is the part of the file most likely to go stale after a product update. - Record the OJ or implementing decision context used for the standards set. - Add clause mapping for partial application and explain any gaps. - Keep update review memos for standards restrictions, withdrawals, or deferred withdrawal dates. ## 4) Risk analysis should be the navigation layer Risk analysis should not sit alone as a static spreadsheet. It should point the reviewer to the exact evidence item that closes each hazard. This is especially important where no harmonised standard exists or where standards are applied only in part. - Link each hazard to the design control, the verification method, and the evidence ID. - Capture foreseeable misuse and external influence assumptions, not only intended use. - Show where residual risk is accepted and how warnings or instructions address it. ## 5) Holding, retention, and availability rules Manufacturers keep the technical file and the DoC for 10 years after placement on the market. Importers must ensure the file can be made available on request, and an authorised representative can be mandated to hold it at the disposal of authorities. That means file ownership, storage, backup, and retrieval speed are compliance controls. - Assign one technical file owner and one backup owner per product family. - Keep a response pack export with the DoC, index, scope memo, and key reports. - Document retrieval SLAs and the path for getting the file from the manufacturer to the importer or authority quickly. ## 6) Suggested folder structure you can actually operate The best folder structure is boring, stable, and easy to export. It should support both routine releases and emergency authority requests. Use the same pattern across product families so everyone can find evidence quickly. - 00-Index for scope memo, applicable legislation list, and index file. - 01-Design for drawings, schematics, BOM, and critical components. - 02-Risk for hazard log, Annex I mapping, and residual risk decisions. - 03-Standards for standards register, clause maps, and update review logs. - 04-Verification for test plans, reports, and calculations. - 05-Labels-and-Instructions for markings, safety information, and translations. - 06-DoC for signed declarations and version history. - 07-Post-market for complaints, CAPA, withdrawals, and recalls. ## Primary sources - [Directive 2014/35/EU - Annex III technical documentation and retention duties (EUR-Lex)](https://eur-lex.europa.eu/eli/dir/2014/35/oj?ref=sorena.io) - Primary source for minimum file contents, risk analysis requirement, and 10 year retention. - [LVD Guidelines (August 2018) - European Commission](https://ec.europa.eu/docsroom/documents/33107?ref=sorena.io) - Useful on importer access to technical documentation, declaration holding, and the practical role of the file in enforcement. - [Blue Guide 2022 - Commission Notice 2022/C 247/01 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022XC0628%2804%29&ref=sorena.io) - Cross regime guidance on technical documentation logic, standards use, and evidence expectations. - [Regulation (EU) 2019/1020 - market surveillance documentation expectations (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2019/1020/oj?ref=sorena.io) - Current framework for documentation availability and market surveillance support. ## Related Topic Guides - [Applicability Test | EU Low Voltage Directive (LVD) 2014/35/EU | In Scope or Excluded?](/artifacts/eu/low-voltage-directive/applicability-test.md): A step-by-step applicability test for the EU Low Voltage Directive (LVD) 2014/35/EU: voltage limits, Annex II exclusions, product vs component. - [Checklist | EU Low Voltage Directive (LVD) 2014/35/EU | CE Marking Readiness Checklist (Technical File + DoC)](/artifacts/eu/low-voltage-directive/checklist.md): An audit-ready CE marking checklist for the EU Low Voltage Directive (LVD) 2014/35/EU: scope memo + Annex II exclusions, Annex I safety objectives mapping. - [Compliance Program | EU Low Voltage Directive (LVD) 2014/35/EU | Operating Model, Controls, and Evidence](/artifacts/eu/low-voltage-directive/compliance.md): Build a scalable compliance program for EU Low Voltage Directive (LVD) 2014/35/EU: product family strategy, scope control, Annex I hazard mapping. - [Conformity Assessment and CE Marking | EU Low Voltage Directive (LVD) 2014/35/EU | Module A, DoC, Technical File](/artifacts/eu/low-voltage-directive/conformity-assessment-and-ce.md): A practical CE marking workflow for EU Low Voltage Directive (LVD) 2014/35/EU: Module A (internal production control), risk assessment. - [Deadlines and Compliance Calendar | EU Low Voltage Directive (LVD) 2014/35/EU | Release Gates, Evidence Cadence, Standards Updates](/artifacts/eu/low-voltage-directive/deadlines-and-compliance-calendar.md): A practical compliance calendar for EU Low Voltage Directive 2014/35/EU: legal milestones from adoption through current application, release gate timing. - [Essential Safety Requirements (Annex I) | EU Low Voltage Directive (LVD) 2014/35/EU | Hazards, Controls, and Test Evidence](/artifacts/eu/low-voltage-directive/essential-safety-requirements.md): Translate EU Low Voltage Directive (LVD) 2014/35/EU Annex I safety objectives into an engineering-ready hazard map: protection against electric shock. - [EU LVD vs EMC Directive | Low Voltage Directive 2014/35/EU vs EMC 2014/30/EU | What Changes for CE Marking?](/artifacts/eu/low-voltage-directive/low-voltage-directive-vs-emc-directive.md): A practical comparison of the EU Low Voltage Directive (LVD) 2014/35/EU and the EMC Directive 2014/30/EU. - [EU LVD vs Machinery Regulation | Low Voltage Directive 2014/35/EU vs Machinery Regulation (EU) 2023/1230 | Electrical Risks and CE Evidence](/artifacts/eu/low-voltage-directive/low-voltage-directive-vs-machinery-regulation.md): A practical overlap guide for Low Voltage Directive (LVD) 2014/35/EU and Machinery Regulation (EU) 2023/1230: when the product is machinery/related product. - [FAQ | EU Low Voltage Directive (LVD) 2014/35/EU | Scope, CE Marking, Technical File](/artifacts/eu/low-voltage-directive/faq.md): High-signal FAQ for the EU Low Voltage Directive (LVD) 2014/35/EU: voltage limits, Annex II exclusions, do you need a notified body. - [Harmonised Standards | EU Low Voltage Directive (LVD) 2014/35/EU | Presumption of Conformity, OJ Lists, and Update Control](/artifacts/eu/low-voltage-directive/harmonized-standards.md): How harmonised standards work under the EU Low Voltage Directive (LVD) 2014/35/EU: presumption of conformity, Official Journal (OJ) references. - [Penalties and Fines | EU Low Voltage Directive (LVD) 2014/35/EU | Enforcement, Market Surveillance Actions, Risk Reduction](/artifacts/eu/low-voltage-directive/penalties-and-fines.md): Enforcement overview for the EU Low Voltage Directive (LVD) 2014/35/EU: what market surveillance authorities typically ask for. - [Requirements | EU Low Voltage Directive (LVD) 2014/35/EU | Manufacturer, Importer, Distributor Obligations](/artifacts/eu/low-voltage-directive/requirements.md): An implementation-grade requirements breakdown for the EU Low Voltage Directive (LVD) 2014/35/EU: obligations for manufacturers, authorised representatives. - [Scope and Products | EU Low Voltage Directive (LVD) 2014/35/EU | Voltage Limits, Exclusions (Annex II), and Examples](/artifacts/eu/low-voltage-directive/scope-and-products.md): A practical scope guide for the EU Low Voltage Directive 2014/35/EU: voltage limits at 50 to 1000 V AC and 75 to 1500 V DC. - [Templates | EU Low Voltage Directive (LVD) 2014/35/EU | Technical File Index, DoC Skeleton, Scope Memo, Evidence Pack](/artifacts/eu/low-voltage-directive/lvd-conformity-assessment-template.md): Copy/paste templates for EU Low Voltage Directive (LVD) 2014/35/EU compliance: scope memo (voltage + Annex II exclusions + overlap). --- [Privacy Policy](https://www.sorena.io/privacy) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). 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