The Chicken or the Egg? Reuniting SOTA and CEP

Description:
Since the launch of Regulation (EU) 2017/745 (MDR), we (clinical and regulatory affairs professionals) have our own chicken and egg dilemma—howcan a Clinical Evaluation Plan be crafted without a comprehensive state-of-the-art analysis, and vice versa? This Solution Circle is tailor-made forprofessionals in medical device regulatory affairs and clinical evaluation, offering insights into this complex interplay.
We recognize the pivotal role of clinical affairs professionals in compiling sufficient clinical evidence for medical devices. Sufficiency is determined bybenachmarks and shaping benchmark parameters that are convincing and meeting Notified Body expectations has developed into a key skill amongClinical Evaluaiton Authors that are searching and reviewing state of the art literature and guidelines. But first things first - in order to do a systematicreview - don't you need a kind of plan in place? And where does this plan come from?
Join us for a profound exploration of unifying state-of-the-art analysis and the Clinical Evaluation Plan. Understand the intricate dynamics, theregulatory nuances, and the critical value this unification brings to the ever-evolving landscape of medical device clinical evaluation. This is not merelya session; it's a deep dive into the heart of regulatory challenges, inviting participants to bring in their own views on this complex topic.