State of the Art (SOTA) under MDR | Notified Body Insights from SZUTEST NB2975 скачать в хорошем качестве

State of the Art (SOTA) under MDR | Notified Body Insights from SZUTEST NB2975

State of the Art (SOTA) is one of the most frequently misunderstood parts of Clinical Evaluation under the EU Medical Device Regulation (MDR 2017/745). In this webinar, we discuss how Notified Bodies interpret SOTA during conformity assessment and how manufacturers should structure their clinical evaluation documentation to meet these expectations. This session includes direct insights from a Notified Body representative from SZUTEST NB2975 and practical experience from real MDR clinical evaluation projects. The objective is to clarify how SOTA should be developed, documented, and maintained across the medical device lifecycle. What You Will Learn In this webinar we cover: • The regulatory meaning of State of the Art under MDR • How Notified Bodies interpret SOTA during clinical evaluation review • How acceptance criteria can be derived from SOTA evidence • Which scientific databases and medical sources should be used • How SOTA supports benefit risk evaluation • Expected update frequency across the device lifecycle • Comparison with non device alternatives such as drugs or surgery • Most frequent SOTA findings during audits and conformity assessment • Applicability of SOTA requirements for Class I medical devices Speakers Engin Çamer Clinical Unit Manager SZUTEST GmbH – Notified Body 2975 Dr. Hatem Rabeh Medical Doctor | Biomedical Engineer Clinical Evaluation Expert Founder of Clinical Evaluation Navigator Topics Covered EU MDR 2017/745 Clinical Evaluation State of the Art (SOTA) Clinical Evaluation Report (CER) Benefit Risk Evaluation Medical Device Regulation Notified Body expectations Literature Review under MDR Medical Device Clinical Evidence