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

Описание: 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