Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CER

Description: The MDR requires the use of measurable outcome parameters in the clinical evaluation to quantitatively evaluate the intended purpose, clinical benefits, and clinical claims related to the device(s) under evaluation. For manufacturers of legacy devices, defining these parameters or endpoints can be challenging, as the performance and safety under MDD were typically assessed qualitatively and without a focus on specific endpoints. Due to this, endpoint definition can be left in the background and done poorly, without considering their potential beyond mere regulatory compliance. This session will highlight how the time and effort invested in identifying valuable endpoints and acceptance criteria are worthwhile not only for the clinical evaluation, but also towards owning a powerful tool for the design of pre-market and post-market clinical data collection activities. The session will start with presenting a straightforward approach to identifying measurable outcome parameters and acceptance criteria by showing different case examples. In addition, the advantages of using these parameters in the clinical evaluation will be presented as a framework for the state-of-the-art discussion and overall assessment of device performance and safety data. Going one step further, this session will also explain how these endpoints can be integrated into the design of pre-market clinical investigations, PMCF surveys and studies and any other clinical studies.