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Clinical Evaluation under MDR Article 61(10): Practical Application of the New Team-NB Position Paper
The recently published Team-NB Position Paper has clarified how Notified Bodies evaluate the use of Article 61(10) and reliance on non-clinical evidence under the MDR. Join regulatory experts from Veranex and TÜV SÜD to explore practical applications, common challenges, and strategies for developing defensible clinical evaluation documentation.
Veranex delivers applied training. TÜV SÜD Academy provides the exam and certificate pathway.
Speakers
Julianne Bobela, PhD
Director, Scientific Affairs
Julianne Bobela, PhD
Director, Scientific Affairs
Julianne Bobela, PhD, is a medical biologist with over 10 years of translational research experience in gene therapy for CNS disorders and more than nine years in regulatory and clinical affairs for medical devices and IVDs, specializing in clinical strategy and regulatory-compliant evaluations.
Dr. Ulrich Nitsche, M.D./Ph.D
Global Director, Centre of Clinical Evaluation, TÜV SÜD
Dr. Ulrich Nitsche, M.D./Ph.D
Global Director, Centre of Clinical Evaluation, TÜV SÜD
Dr. Ulrich Nitsche, M.D./Ph.D., is Global Director and Head of the Centre of Clinical Evaluation, managing all internal and external clinicians for the notified bodies TÜV SÜD NB0123, TÜV SÜD NB2443, and the approved body TÜV SÜD AB0168. Besides his work as an internal clinician, Ulrich Nitsche is member of the German Institute for Standardisation (DIN-Normenausschuss) in the Clinical Trials / Clinical Evaluation Working Group. In addition, he is member of the Ethics Committee of the Technical University of Munich and of the Specialised Ethics Committee for Special Procedures of the BfArM. Ulrich Nitsche is a board certified visceral surgery and active emergency physicaion as well as medical incident Commander (senior emergency physician).
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