Short answer
A complete EU technical file has six parts: a general product description with design documents, the EU Declaration of Conformity, test reports from accredited laboratories, a risk assessment, instructions and safety information, and the label with CE marking. It must be kept for 10 years and provided to authorities on request.
The technical file, or technical documentation, is the proof behind the CE marking. You do not send it to anyone in advance. But when a market surveillance authority or customs asks for it, it must be available quickly, complete and consistent. In practice, that is the job of the EU operator named on your product.
The six components
1. General description and design documents
What the product is, what it is for, and how it is built: photos, drawings, circuit diagrams or mechanical drawings, and a list of critical components, such as power supplies, plugs, batteries and materials in contact with skin or food, with their own certificates.
2. EU Declaration of Conformity
A single document, signed by the manufacturer, listing all applicable EU legislation and the harmonised standards used, with dates. Its structure follows Annex III of Decision 768/2008/EC. It must be translated into the language required by the country of sale.
3. Test reports
Reports from laboratories accredited to ISO/IEC 17025 for the standards tested, proving that the product meets the essential requirements. They must cover the exact model sold, and the current edition of each standard.
4. Risk assessment
How the product could cause harm in normal use and in reasonably foreseeable misuse, and what you did about it: design measures, protective features and warnings. Many files arriving from outside the EU lack this document entirely.
5. Instructions and safety information
The user manual, safety warnings and technical data sheet, in the language of each country where the product is sold. For Romania, consumer information must be in Romanian.
6. Label and CE marking
The final label artwork with the CE marking at least 5 mm high, manufacturer details, EU operator details, and a type, batch or serial number.
The five most common mistakes
- Test report for a different model. The report covers “Model A”, but you sell “Model A-Pro” with a different power supply.
- Outdated standards. The report cites an edition that is no longer harmonised.
- Missing legislation. An electrical product declared only under LVD, with EMC and RoHS forgotten.
- Declaration signed by the wrong company. A trading company signs instead of the actual manufacturer.
- No Romanian or local-language instructions. The product is sold to consumers with English or Chinese manuals only.
How long and in what format?
Keep the file for 10 years after the last product is placed on the market. A well-indexed PDF set is perfectly acceptable. What matters is that every document matches the product and the others: same model name, same components, same standards.
Before the inspection, not during it
When an authority asks for documents, the deadline is short, often 10 to 15 working days. That is not the moment to discover the test report is for the wrong model.
ISOCONSULT S.R.L. reviews your technical file, produces a gap report and completes what is missing before we accept a mandate. Request a quote.
This article is general information about EU product legislation and is not legal advice. Requirements depend on the exact product; contact us for an assessment of your case.