CE Technical Documents

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EU law requires that after CE-labeled products are put on the European market, their technical files must be stored in the EU for inspection by supervisory agencies at any time. If the content contained in the technical file changes, the technical file should also be updated in time.

A technical file or technical document is a set of documents that contains all relevant information about a specific product, including information about the following products:

  • · Design

  • · Function

  • · Instructions for use

  • · Testing

  • · Safety

The main purpose of the technical file is to prove that the product complies with the applicable health and safety EU directives. Before manufacturers can paste the CE mark on their products, they must prepare a technical document proving that their products comply with relevant EU safety standards.

What documents must be included in the technical file?

The required content of the technical file is determined by the regulations that the product must comply with. From the type of document to the information contained, each EU directive has its own set of requirements for technical documents.


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