This chapter shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of the IVDR and in particular the one mentioned in the Annex I of the IVDR – General Safety and Performance Requirements. Three major things shall be referenced in this chapter:
The Clinical Evidences of the device, including a Performance Evaluation Plan and a Performance Evaluation Report (Analytical Performance Report, Clinical Performance Report, Scientific Validity Report).
The Stability Studies of the device, including a Stability Studies Protocol + Report.
The Software Validation Evidences (if necessary), including a Software Validation Protocol + Report.