Scientific Validity Report (SVR)

What is a Scientific Validity Report?
The Scientific Validity Report (SVR) is used to describe the association of a specific analyte to a clinical condition or a physiological state. This is typically based on a literature review, expert opinions, proof-of-concept studies and information from similar devices.
The SVR will follow the requirements as defined in the European In-Vitro Diagnostic Regulation 2017/746 (IVDR), Annex XIII, Part A, Section 1.2.1.
AML Christensen’s service
At AML Christensen, we know how to develop SVRs that comply with the requirements of the IVDR and relevant guidelines. As such, we are happy to help you create the first SVR for your device and ensure that the SVR is regularly updated throughout the device’s lifetime.
At AML Christensen, we have a proven SVR template, which has been developed to ensure that the requirements of the IVDR are met. Your SVR may be built using the AML template or we can use your own template, if so preferred.