Technical file - is a set of documentation submitted to the conformity assessment body for the conformity assessment procedure to assess compliance with the Technical Regulations.
The content of the technical file depends on the type of medical device, its risk class, operation, maintenance, and the conformity assessment process.
It must contain the documents necessary to identify the product being assessed and to confirm that the manufacturer has complied with the requirements of the Technical Regulations for these products.
The formation of the Technical File is a responsible task assigned to the party that initiated the conformity assessment procedure with the Technical Regulations. The minimum required scope of documents included in the Technical File is determined by the Technical Regulations. In this case, the conformity assessment body may require the applicant to provide additional documentation.
a general description of the medical device (including any planned modifications of such a device, as well as its intended use);
design documentation - design drawings, information on the envisaged methods of manufacturing a medical device, diagrams of components, assemblies, circuits, as well as descriptions and explanations necessary for understanding this design documentation;
the results of design calculations and inspections;
