Technical File

A technical file is the compiled set of documents that together constitute the technical documentation for a product. The terms 'technical documentation' and 'technical file' are often used interchangeably, though some legislation uses specific terminology. The technical file contains all evidence supporting the conformity assessment.

EU Compliance Documents Overview

To compile all technical documentation into a single accessible record that demonstrates product compliance with applicable EU requirements and supports market surveillance activities.

Requirements depend on the product, applicable legislation, and supply chain. This information is provided for general guidance and does not constitute legal advice.

Browse all EU Compliance Documents · Knowledge Hub · Check which requirements may apply