The Technical File, or technical documentation, records how a product meets the requirements that apply to it. Identify the product, intended use, applicable legislation and assessment route before deciding which evidence is needed. A file is supporting evidence; it is not a universal CE certificate.
Contents and evidence
Depending on the legislation and product, the file includes a description, design and manufacturing information, explanations, risk analysis, standards or other technical specifications, calculations and test reports. For connected equipment, relevant firmware versions, interfaces and security evidence help establish the assessed configuration. Schematics, a BOM and release records are useful engineering evidence; their required detail depends on the assessment.
Competent testing is essential. An accredited laboratory may be a sensible choice, but internal-control procedures do not universally require accredited external laboratories for every test. A notified body’s involvement follows the specific legal route. Some routes require documentation to be submitted to that body before market placement.
Responsibility, retention and requests
The manufacturer is responsible for preparing the documentation. An authorised representative performs only tasks permitted by the legislation and specified in a written mandate; this does not automatically transfer the manufacturer’s responsibility. An importer who markets a product under its own name may assume manufacturer obligations.
Retention is law-specific. Many CE regimes require ten years after the individual product is placed on the market. MDR Article 10(8) requires ten years, or fifteen for implantable devices, after the last device covered by the EU declaration has been placed on the market. CRA Article 13(13) requires at least ten years or the support period, whichever is longer. Respond to an authority’s reasoned request within the applicable deadline; there is no universal ten-day rule.
CRA documentation
The main CRA requirements apply from 11 December 2027. Annex VII specifies technical documentation. Annex I requires a machine-readable SBOM covering at least top-level dependencies. Support is determined under Article 13(8), normally at least five years, with the expected-use exception and relevant longer-use factors. Reporting under Article 14 has applied since 11 September 2026.
Practical checklist
- Establish scope and the conformity route.
- Link each applicable requirement to evidence.
- Identify the tested hardware and software configuration.
- Record changes, versions and any reassessment.
- Set the correct retention period and authority-response process.