She is a specialist in anesthesiology and critical care medicine, practicing at a university hospital in Poland and teaching at the Medical University of Silesia. Since 2019, she has served as a Clinical Expert for TÜV Rheinland, conducting medical device clinical evaluations under the EU MDR. She has expertise in clinical evaluation, PMCF, benefit risk assessment, and the appraisal of clinical evidence.

This presentation explores the role of clinical expertise and healthcare professionals in MDR clinical evaluation. It will examine how clinicians assess a device’s intended purpose, clinical claims, comparator therapies, and clinical data. The session will cover benefit risk assessment, evidence gaps and PMCF planning, CECP and high risk device review, and provide a practical CER checklist along with key considerations for real world application.