What is technical documentation for EU product compliance?

Dutch term: Technisch dossier | Legal basis: Decision 768/2008/EC + sector-specific legislation

Technical documentation (technisch dossier) is the file compiled by the manufacturer that demonstrates how a product meets the essential requirements of the applicable EU harmonised legislation. The file must cover the product's design, manufacture, risk assessment, test results, conformity assessment procedure followed, and any relevant technical specifications or harmonised standards applied.

The technical documentation must be compiled before the product is placed on the EU market and must be kept available for national market surveillance authorities for a defined period (typically ten years after the last product was placed on the market). The documentation must be in a language acceptable to the authority (typically English or the national language of the market).

Why it matters for international businesses

For manufacturers and importers, the technical file is where the real compliance work sits. A well-structured file is the best defence in a market surveillance inspection and the foundation of any product liability defence.