Webinar: Complexities of IVDs in Clinical Trials

Assays and In-Vitro Diagnostic Medical Devices (IVDs) are routinely used in clinical trials for patient selection, monitoring and evaluation of outcomes. In order to understand the regulatory requirements associated with these valuable tools, we require to examine the information they provide in the context of the trial and the requirements of the EU IVD Regulations (2017/746). With real-life examples, this webinar is designed to offer practical advice to help those running clinical trials involving IVDs.

Learning Outcomes:

• When a clinical trial assay is an IVD
• The advantages of using CE marked IVDs in a clinical trial
• Know when a performance evaluation has to be performed as part of a combined clinical trial
• Consolidate knowledge by consideration of different use scenarios of IVDs in clinical trials

About the Speaker

Edward Staunton 
Director, Regulatory Affairs & Quality – Medical Devices and IVDs
Edward Staunton is a highly experienced regulatory affairs and quality expert specialising in in vitro diagnostics (IVDs), medical devices and their intersection with clinical trials. In his current role at Clinigen, he leads the regulatory-and-quality agenda for devices and diagnostics, guiding clients through complex EU, UK and global regulatory frameworks.

Edward’s work spans the full product lifecycle: from early feasibility and first-in-human studies through pivotal clinical trials, with particular focus on diagnostic devices, companion diagnostics and the integration of IVDs into therapeutic development programmes. He has delivered training courses, workshops and consulting services on medical device regulatory strategy, quality management systems and device regulatory readiness.