Technical Files and Declaration of Conformity
European Directives and Technical Documentation: An Essential Requirement
One of the key obligations for manufacturers is the preparation and maintenance of Technical Documentation, which serves to demonstrate product compliance with the essential safety requirements set out in the applicable directives.
The Technical Documentation must prove to the competent market surveillance authorities that the product has been designed and manufactured in accordance with the applicable standards and directives.
Failure to possess or update this documentation may lead to sanctions, product withdrawal from the market, or even prohibition of commercialization.
Maintaining proper and up-to-date documentation is therefore crucial to ensuring legal compliance, consumer safety, and the continuity of product commercialization.
What is Technical Documentation?
It is a set of documents providing detailed evidence on the product’s design, production, and conformity.
It must be retained by the manufacturer for at least 10 years from the last date the product was placed on the market and made available upon request by market surveillance authorities.
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Product description and intended use
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Technical drawings and design/production schemes
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List of applicable directives and standards
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Test reports and risk analysis proving product safety
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User and maintenance instructions
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EU Declaration of Conformity or Declaration of Performance (for construction products).
CE Technical Documentation Ready for Inspection
We prepare and update the complete Technical File (description and intended use, applied standards, design drawings, test reports, risk analysis, instructions, EU Declaration of Conformity) with 10-year retention. This minimizes the risk of penalties, recalls, and commercialization interruptions.