Meaning
Dossiers compiled for products under the Radio Equipment Directive must contain specific detailed evidence of compliance. Compiling the technical documentation annex v involves gathering all the test reports, schematics, block diagrams, and manufacturing documents that prove a wireless device meets the essential requirements of the directive. This dossier must be presented to market surveillance authorities upon request.
Dossier Content
The required documents include a general description of the radio equipment, conceptual design drawings, and a list of the harmonized standards applied during testing. It also requires the results of design calculations and examinations carried out. This documentation must be kept for ten years from the date the product is placed on the market.
It must be updated whenever any changes are made to the design. This continuous update process ensures that any changes do not negatively affect compliance.
Compliance Verification
National regulators and notified bodies analyze this file to verify that the product’s compliance is supported by valid technical evidence. If the documentation is incomplete, the product cannot be lawfully sold in the European Union. Having a well-structured file prevents delays during audits or certification reviews.
It is the primary reference used to resolve any doubts about compliance.
Document Control
Regular updates to this file are necessary to ensure it reflects the current state of the product and the latest standards. Any change in the firmware or board layout must be documented and assessed. Failure to keep the documentation current can lead to serious compliance failures during market audits.