When a shipment is routed to document review under TAREKS, the technical file is generally at the center of the review. We covered the general content of the technical file in our article What Is the CE Technical File?; in this article we focus specifically on how the file is reviewed during TAREKS/customs inspection.
What Is the Purpose of the Review?
The purpose of technical file review is to verify whether there is genuine engineering assessment behind the CE mark and declaration of conformity on the product. The review focuses not on whether the file exists, but on whether its content is consistent with the product and with the declared standards.
Elements Typically Checked in the Review
- The consistency of the product's general description and technical characteristics with the actual product
- The list of applied directives and standards, and their currency
- Whether the risk analysis report is product-specific and consistent
- Whether test reports (if any) match the product and the standards
- Consistency of the user manual's content with the technical file
- Whether the EU Declaration of Conformity matches the directives and standards listed in the technical file
The Review Process, Step by Step
- The relevant regional directorate requests the technical file related to the shipment.
- The file's product description and scope are compared against the actual product.
- It is checked whether the applied standards are current and correctly chosen.
- The risk analysis and test reports are reviewed for consistency with the declared conformity.
- Additional explanation/documents are requested for points found missing or inconsistent.
- If the review is favorable, the process proceeds to TAREKS approval.
Common Non-Conformities
| Non-Conformity | Possible Consequence |
|---|---|
| Technical file being generic/template-based, not product-specific | Request for additional explanation, loss of trust |
| Product-specific hazards omitted from the risk analysis | File deemed incomplete |
| Standard references showing an outdated version | Inconsistency query against the declaration of conformity |
| User manual contradicting the technical file | Additional review or inspection |
Frequently Asked Questions
Should the entire technical file be sent?
A summary file is generally sufficient; but if additional information is requested during review, it is important that the entire file be quickly accessible.
Should the importer prepare the technical file?
The responsibility for preparing the technical file belongs to the manufacturer; but the importer needs to obtain this file and keep it ready to present for TAREKS review.
What is checked most in technical file review?
The consistency of the risk analysis with the product, the currency of the applied standards, and whether the technical file matches the declaration of conformity are the most frequently checked elements.
Conclusion
Technical file review under TAREKS aims to verify the genuine engineering work behind the CE mark. Having a file that is product-specific, based on current standards, and consistent with the declaration of conformity is the key to a smooth review.
For more information, see our TAREKS & Import consultancy service.
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