Meaning
Compliance documentation dossiers that compile all necessary evidence of a radio product’s conformity with European Union legislation must be assembled before placing the equipment on the European market. The RED technical construction file includes design drawings, component datasheets, test reports and the formal declaration of conformity. This documentation must be maintained by the manufacturer for ten years after the last unit of the product has been placed on the market.
Dossier Compilation
The dossier brings together test reports covering electromagnetic compatibility, radio frequency performance, electrical safety and human exposure to electromagnetic fields. Hardware schematics, layout drawings and the bill of materials are also included to fully describe the physical product. Software versions that affect the radio performance must be explicitly documented to ensure that updates do not invalidate the compliance status.
Regulatory Audit
National market surveillance authorities can demand to inspect this folder at any time to verify that the product complies with the radio equipment directive. Having a complete and organized file reduces the risk of sales bans or fines during a market audit.
Market Access
Assembling the RED technical construction file is the legal prerequisite for applying the CE mark to the product. Without this mark, the device cannot be legally imported or sold within the European Economic Area.