Technical file is a set of documents submitted to the conformity assessment body for conducting the conformity assessment procedure with the Technical Regulations. It must have the documents necessary for both identifying the evaluated product and for verifying that the manufacturer fulfills the requirements of the Technical Regulations for the products.
Making of Technical file is a responsible task entrusted on the party initiating the TR conformity assessment procedure. The minimum required contents of the document included in the Technical file is determined in the Technical Regulations. However, the conformity assessment body may require the applicant to provide additional documents.
Before submitting the Technical file to the selected conformity assessment body, it must be ensured that the document not only allows for the conformity assessment procedure, but also meets the requirements of the national legislation of the country where the medical device is introduced.
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