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 MDR or IVDR present the scope of technical documentation of the medical device.
What is the scope of the technical documentation according to MDR or IVDR?
The scope of technical documentation is dependent on the product class, which determines the path of product conformity assessment. The list of required documents are presented in the Annex II and III to new regulations. 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.