Technical Documentation

The Technical Documentation must prove that the product fulfils the requirements laid down in the Medical Devices Directive. The Technical Documentation for medical devices should take account of the following aspects:

•  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 also)
• 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 sterilisation process
• Biocompatibility
• Clinical evaluation