Technical File

The Technical File (or Technical Documentation) is the comprehensive collection of documents that serves as the legal proof of your machinery's compliance. It acts as the evidence backing up your CE Mark. Without this dossier, your Declaration of Conformity (DoC) is essentially a claim without proof.

This file must contain detailed design drawings, circuit diagrams, the full Risk Assessment, test reports (such as EMC Testing results), and user manuals. For North American exporters, it is crucial to distinguish this from a standard product manual; it includes proprietary engineering data and rigorous justification of how you met Essential Health & Safety Requirements (EHSRs).

You are required to retain this file for 10 years after the last unit is produced. While you typically do not send this sensitive file to customers, it must be made available to EU authorities immediately upon request. Often, an EU Authorized Representative is designated to ensure this file can be presented to regulators on European soil.