[Home](/)/[Resources](/resources)/UK Technical File DocumentationTechnical # UK Technical File: Structure and Compliance Guide The technical file is the foundation of UKCA marking compliance. It contains all technical documentation demonstrating that a product meets applicable essential requirements. Proper technical file management is essential for market access and regulatory defense. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fuk-technical-file) ## Technical file structure ### Product description and specifications Complete technical description, model variants, intended use, user groups, and technical specifications. ### Design and manufacturing information Design drawings, schematics, component lists, BOM, manufacturing processes, quality control procedures. ### Standards and requirements List of designated standards applied, essential requirements addressed, deviations from standards with justifications. ### Test reports and results Test plans, test reports from accredited labs, in-house test results, pre-compliance testing documentation. ### Risk assessment Hazard identification, risk analysis, risk evaluation, risk control measures, residual risk assessment. ### Declarations and certificates Declaration of Conformity, certificates from Approved Bodies (if applicable), supplier declarations, material declarations. ### Instructions and labeling User instructions, safety warnings, installation instructions, product labeling, packaging information. ## Retention periods by regulation Regulation Retention period General product regulations 10 years Machinery 10 years after last unit placed on market Medical devices Lifetime of device + 10 years Pressure equipment 10 years PPE 10 years Note: 10 years is standard for most UK product regulations after the last unit is placed on the market. ## Technical file management Effective technical file management requires systematic organization, version control, and accessibility. Key practices include: * **Unique identification:** Each technical file should be linked to specific product models/versions through model numbers or batch numbers. * **Change control:** Document all changes to the technical file with dates, reasons, and approval. Maintain version history. * **Access control:** Ensure authorized personnel can access the technical file when needed, while maintaining security and confidentiality. * **Supplier integration:** Include supplier declarations and material declarations in the technical file. Maintain supplier documentation that supports your conformity assessment. * **Regular review:** Review technical files periodically to ensure they remain current, especially when standards or regulations change. ## Technical file vs technical documentation The technical file is a specific set of documentation demonstrating compliance with applicable regulations. It may be a subset of broader technical documentation maintained by the organization. Not all technical documentation needs to be in the formal technical file. Focus on documentation that directly supports conformity assessment: test evidence, risk assessment, applied standards, and declarations. Detailed manufacturing process documentation, while important for quality management, may not always need to be in the regulatory technical file. ## 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/09-ukca-marking-for-electronics-products)[Free Compliance Roadmap](/platform/new) [Prefer to read? Get the book — $24.99](/books/09-ukca-marking-for-electronics-products) ## Frequently asked questions ### Where must the technical file be kept? The technical file must be available in the UK for authorities to access. For UK-based manufacturers, this is typically at their premises. For foreign manufacturers, the UK Responsible Person or Authorised Representative must maintain the technical file and make it available upon request. ### Can the technical file be electronic? Yes, technical files can be maintained electronically. The format must enable authorities to review documentation effectively. Electronic files must be properly organized, backed up, and accessible when requested. ### What happens if I modify the product? Product modifications may require updates to the technical file and potentially a new conformity assessment. Evaluate whether changes affect compliance with essential requirements. Document all changes and maintain version control of the technical file. [ Map your product, free Every standard, document, and test that applies — free, no account required. Start mapping](/platform/new)[ Want an expert to handle your compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $149](/courses/09-ukca-marking-for-electronics-products)[Prefer to read? Get the book — $24.99](/books/09-ukca-marking-for-electronics-products) Related guides * [UKCA Marking OverviewComplete guide to UKCA marking for the Great Britain market: requirements, timeline, costs, GB vs NI differences, and how to tr…](/guides/ukca-marking) * [UK Declaration of ConformityComplete guide to UK Declaration of Conformity: required content, format, signatory requirements, and how to create a compliant…](/guides/uk-declaration-of-conformity) * [UKCA Marking ChecklistComplete UKCA marking checklist for startups and manufacturers: step-by-step compliance verification for UK market entry.](/guides/ukca-checklist) * [UK Post-Market SurveillanceComplete guide to UK post-market surveillance requirements: monitoring, incident reporting, corrective actions, recalls, and on…](/guides/uk-post-market-surveillance) Educational resource only. Technical file requirements vary by product regulation. Always verify specific requirements for your product category.