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

Expert webinar with Engin Çamer (SZUTEST NB2975) & Dr. Hatem Rabeh (Clinical Evaluation Navigator)

State of the Art (SOTA) is one of the most frequently misunderstood parts of Clinical Evaluation under EU 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.

Key Takeaways from This Webinar

SOTA is not a literature search — It begins with clinical understanding of the disease, indication, and treatment pathway. The literature search is a tool used to gather SOTA evidence, not the SOTA itself.

Always define benefit-risk parameters — The primary outcome of a SOTA analysis should be clearly defined benefit and risk parameters, their measurement methods, and evidence-based acceptance criteria.

Use multiple scientific databases — MDR and MDCG documents require at least two databases. Prioritize aggregate data: meta-analyses, systematic reviews, and clinical guidelines from European medical societies.

Position your device in the treatment pathway — The SOTA must explain where your device fits: first-line treatment, surgical alternative, or complement to pharmacotherapy. Compare with all relevant alternatives, including non-device options.

SOTA feeds directly into risk management — Side effects identified from state-of-the-art literature must be listed in your risk analysis, even if your own clinical data shows no adverse events.

Article 61(10) still requires SOTA — Even for devices not requiring clinical data, you must identify benefit-risk parameters from the state of the art. These parameters may be purely technical rather than clinical.

Notified Bodies reproduce your search — Reviewers will verify your literature search protocol by reproducing it. Ensure your methodology captures the key publications in your field and that your audit trail is transparent.

Make the reviewer’s work easy — Answer MDCG 2020-13 questions directly in your CER. Highlight extracted information in source PDFs. Clear, concise reports accelerate conformity assessment and reduce nonconformities.

What We Cover in This Session

● The regulatory meaning of State of the Art under EU MDR 2017/745

● How Notified Bodies interpret SOTA during clinical evaluation review

● How acceptance criteria can be derived from SOTA evidence

● Which scientific databases and medical sources to use

● How SOTA supports benefit-risk evaluation under MDR

● Expected update frequency across the device lifecycle

● Comparison with non-device alternatives (drugs, surgery)

● Most frequent SOTA findings during NB audits and conformity assessment

● Applicability of SOTA requirements for Class I medical devices under Article 61(10)

Meet the Speakers

Engin Çamer

Clinical Unit Manager — SZUTEST GmbH, Notified Body 2975

Engin Çamer works as an internal clinician for SZUTEST, a Notified Body designated in Germany under the EU Medical Device Regulation. With approximately 15 years of experience in the medical device field, Engin is directly involved in the review of clinical evaluation documentation submitted by manufacturers seeking CE marking. His daily work includes assessing state-of-the-art analyses, clinical evaluation reports, and benefit-risk documentation as part of the conformity assessment process.

Dr. Hatem Rabeh

Medical Doctor | Biomedical Engineer | Clinical Evaluation Expert

Dr. Hatem Rabeh is a Medical Doctor with a Master of Science in Biomedical Engineering and over 8 years of experience as a Clinical Evaluation Expert for medical devices. He has supported manufacturers across all device classes — from Class I to Class III — including active implants, navigation systems, robotic surgery platforms, and AI/ML-based software devices.

As the founder of Clinical Evaluation Navigator, Dr. Rabeh has published over 100 articles on clinical evaluation best practices and built a community of regulatory professionals who collaborate weekly. His daily work involves creating SOTA reports, writing Clinical Evaluation Reports, building MDR-compliant documentation, and responding to Notified Body queries.

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Who Should Watch This Webinar?

This session is designed for anyone involved in clinical evaluation documentation under the EU Medical Device Regulation:

✓ Regulatory Affairs Managers preparing clinical evaluation submissions for Notified Body review
✓ Clinical Evaluation Specialists writing CERs, CEPs, and SOTA reports under MDR
✓ Quality Managers responsible for MDR compliance and addressing nonconformities
✓ Biomedical Engineers conducting literature reviews and SOTA analyses
✓ MedTech Startups navigating the MDR landscape and building their first clinical evaluation documentation
✓ Consultants and CROs advising manufacturers on clinical evaluation strategy

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Join the Clinical Evaluation Navigator community to access weekly expert calls, discuss real-world challenges with regulatory professionals, and get direct guidance from Dr. Hatem Rabeh on clinical evaluation, SOTA, CER, and MDR compliance.

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