What goes in a product technical file?
Start with the applicable product rules and your role, then assemble a file linking the exact product to its risk assessment, drawings, materials, test evidence and relevant declaration. Control revisions and arrange access to the underlying documents before selling. Cambridge China Bridge can help gather factory documents through its staff in China.
Define the product, market and your role
Create a cover sheet identifying the model, variants, intended use, users, manufacturer and sales territory. Record the applicable product rules, assessment route and relevant declaration. Confirm the arrangements applicable to your sales territory with the relevant authority. Use our CE and UKCA guide for marking choices and importer versus own-brand responsibilities.
Use the UK compliance finder as a starting point, then confirm the scope against the product itself. For electrical goods, our electrical import rules guide covers overlapping requirements. This checklist is a filing method: adapt its contents to the applicable regime rather than treating it as a universal legal template.
Link each risk to a control and evidence
Manufacturers remain responsible for assessing product risks, identifying relevant requirements and documenting how they address them. Make the assessment specific to your product: who could be harmed, during which activity, by what hazard, and how? Consider installation, normal use, foreseeable misuse, cleaning and maintenance where relevant.
For each hazard, record the design control, supporting drawing or test, remaining risk and any warning. Explain why the control is adequate. A supplier's generic assessment is a starting point for review, not a finished assessment for a different configuration. Keep unresolved risks visible and assign someone to resolve them before release.
Describe exactly what the factory will make
Gather the product specification, assembly and component drawings, circuit diagrams where relevant, BOM, material specifications and photographs of the approved sample. Give documents revision identifiers and explain symbols or technical details needed to understand them. Identify safety-critical components by supplier and part reference rather than descriptions such as equivalent motor.
Connect the design pack to the production order. Agree how the factory requests material or component substitutions and who reviews their effect on the risk assessment and test evidence. Retain approved label artwork, packaging and instructions alongside the design records so the file describes the product you intend to sell.
Build a test evidence register
For each relevant requirement, record the evidence used, the report reference, the standard and edition applied, the tested model and configuration, and any exclusions. Obtain complete reports, including sample photographs and results. Ask the laboratory to confirm authenticity and explain any difference between the tested sample and your production specification.
Record failures, corrective changes and subsequent evidence rather than keeping only a pass certificate. Keep production inspection records linked to the approved design and sample; our quality inspection guide explains those checks. Use inspection to check production consistency, alongside the evidence addressing the applicable requirements.
Control versions, access and release
Maintain an index showing each document's owner, revision, approval status and storage location. Link the applicable declaration to the product configuration and supporting evidence. Keep superseded versions identifiable and connect production batches to the versions used. When the product changes, record the review of affected risks, drawings, reports, labels and instructions.
Before authorising sale, check that unresolved items are closed and that documents can actually be retrieved. Agree access to confidential factory records before ordering, including what happens if the supplier relationship ends. Record the retention period and its trigger from the applicable product rules. Assign responsibility for backups, access permissions and reviewing changes in requirements.
Frequently asked questions
Is a test certificate enough for a technical file?
No. Build a connected record of the product, risks, design and supporting evidence. Obtain the full report and check its scope against the configuration you will sell.
Can I use the factory's technical file?
Use it as source material after checking the model, configuration and completeness. Agree access to underlying records. If you sell under your own brand, confirm your responsibilities with the relevant authority and consult our marking guide.
Do I need new tests after changing a component?
Review what the change affects before accepting it. Ask the laboratory or relevant assessor whether existing evidence covers the revised configuration, and record the reasoning and any additional testing.
How long should I keep a product technical file?
Check the applicable product rules for the retention period and its starting point. Record both in your document register and retain the versions linked to the products sold.