Technical File Preparation

How should technical documentation be prepared?

The purpose of developing technical documentation is to ensure compliance with the essential requirements of the medical device. The conformity assessment procedures included in the annexes to the MDD Directive present the scope of technical documentation of the medical device. This scope varies depending on the choice of the conformity assessment procedure, however, it is possible to distinguish the common elements which they are:

  •  a general description of the product, including planned variants,
  • design drawings, manufacturing methods envisaged including components
  • the results of risk analysis,
  • list of harmonised standards applied,
  • results of design calculations made and test results, including those concerning compatibility with other products,
  • clinical data,
  • description of the sterilisation methods used (if applicable),
  • labels and instructions for use,
  • declaration of conformity.

The scope of technical documentation is dependent on the product class, which determines the path of product conformity assessment.

How can we help?

The experts of MDR Regulator on behalf of the manufacturer will carefully prepare the technical documentation or verify it.