Building of the technical documentation

The Technical Documentation must prove that the product fulfils the requirements in the Medical Devices Directive.

The Technical Documentation for medical devices should follow listed aspects as below:

Table of Contents with revision status and proof of completeness of the file
Name and address of the manufacturer (if necessary, name of the European representative)
Declaration of Conformity
Description of product family
Proof of fulfilment of the Essential Requirements (Annex I)
Risk analysis (in accordance with EN ISO 14971)
List of the applied standards
Information for use
Labels
Packaging
Test reports
Validation of sterilization process
Biocompatibility
Clinical evaluation