Building of the technical documentation

The Technical Documentation must provide evidence that the device fulfils the Essential Requirements of the IvD Directive. The special requirements to be met by the various conformity assessment procedures are described in Annexes III to VII. The Technical Documentation should include the following basic points:

• Table of Contents, revision status and date
• Name and address of the manufacturer
• A general description of the device and, if necessary a sample, drawings, photos
• Details of the materials used
• A function description and intended use of the device
• The instructions for use and product identification
• Product design documents with descriptions and explanations
• If required, a list of the applied standards
• A risk analysis
• Proof of compliance with the Essential Requirements (Annex I)
• Results of tests and inspections
• Results of the clinical assessment
• If required, additional documentation after consultation