The technical file for the CE mark

CetN provides manufacturer and importers with a comprehensive consulting service for all those who are required to make CE marking.

Contact us immediately if  your are a manufacturer or an importer , penalties are very severe for those who do not comply with the law.

You can call us at +386 40 269 896 or send an email to info@cetn.eu and request all the information you want.

We will give you all the necessary clarifications and we will send you a free quote for our advice.

The Machinery Directive 2006/42 / EC and all other Community Directives define all the documentation that the manufacturer, his authorized agent, if the manufacturer is outside the EEC or the importer of materials, products, machines or installations must prepare in order to be able to affix the CE mark.

The most important part of the CE marking and its documentation is represented by the technical file, which is indicated in all the directives relating to the products subject to marking, and unfortunately as is often the case, this is the least known and most neglected part, perhaps because it is the most Complex and is the basis for the product realization. Some even confuse it with the manual.

The technical file is a collection of all documents made during the design, construction, and testing of the machine. It includes structural calculations, characteristics of materials used, construction drawings, diagrams, sales material documentation, airborne noise measurements and electromagnetic compatibility and all other key features of the product.

fascicolo tecnicotechnical file

First of all, the technical dossier must include the risk analysis, which is in fact the starting point for all the work required for CE marking.

The technical file must not be provided to the customer, but must be filed from  the manufacturer, it does not have to be physically present to affix the CE mark to the product.

The rules state that, in response to a request from the competent authorities, the manufacturer is in a position to make it available in the required time.

The technical file must be carefully analyzed with an experienced technician, preferably external person not an employee, who, in addition to the technical aspects knows the legal ones.

For this reason, the realization of this document and the collection of all the information necessary for its implementation are the longest, most expensive and difficult work of the CE marking.

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