TECHNICAL FILE EVALUATION

A technical file is a set of documentation submitted to the conformity assessment body for conducting a conformity assessment procedure with the Technical Regulations. It must contain the documents necessary both to identify the product being evaluated and to confirm that the manufacturer complies with the requirements of the technical regulations for these products.

Preparation of the Technical file is a responsible task assigned to the party that initiated the procedure for assessing the conformity with the TR. The minimum required volume 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.

Before submitting the Technical File to the selected conformity assessment body, it is necessary to make sure that this document not only allows the conformity assessment procedure to be carried out, but also meets the requirements of the national legislation of the country in which the medical device is introduced.

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