Clinical Evidence for In Vitro Diagnostic Medical Devices

Clinical evidence is foundational in the evaluation of the clinical performance, safety, and effectiveness of in vitro diagnostic (IVD) medical devices. In an innovation landscape for IVDs that is rapidly evolving, fit-for-purpose principles for clinical evidence are therefore essential. 

In 2012, the GHTF Study Group 5 on 'Clinical Safety/Performance' published guidelines on clinical evidence, performance evaluation and clinical performance studies for IVD Medical Devices. Since then, advances in the field of IVD technologies (such as increased availability and use of self-testing, next generation sequencing, IVD software) have demonstrated great benefits for healthcare provision. 

The Clinical Evidence for IVD Medical Devices Working Group aims to review and update three existing GHTF guideline documents, taking into account developments in the field in the past decade, including lessons learnt from the recent COVID-19 pandemic. This work will ensure the guidelines remain up to date considering evolving regulatory frameworks and the state-of-the-art in healthcare practices.