• Format

    Online
    Webinar

  • Date and Time

    November 20, 2025

  • Time

    13:00 CET

  • Level

    All

  • Price

    Free

“Appropriateness” of Clinical Data Under Regulation (EU) 2017/745 - A Case Study and Survey

This event took place November 20 as a part of our Free Webinar Series and the recording and presentation are available.
Regulation (EU) 2017/745 on medical devices (MDR) introduced enhanced requirements for clinical evidence but left certain aspects open to interpretation, particularly concerning what qualifies as “sufficient clinical evidence” for medium-risk, Class IIb non-implantable CE-marked devices.
This webinar presented findings from a research study that examined how notified bodies and manufacturers interpret the MDR’s expectations for clinical data and evaluated the feasibility of conducting clinical evaluations without new clinical investigations.

Meet the instructor

Elisabeth Oltmanns

Elisabeth Oltmanns is a PhD student with Tom Melvin and her research focuses on the integration of clinical and non-clinical data (eclipse-md.com). With a background in Biomedical Engineering and an MSc in Regulatory Affairs, she combines technical expertise with regulatory insight. Alongside her academic work, she consults through Escentia, a boutique clinical affairs consultancy supporting medium-risk medical devices. Passionate about advancing medical device development, she is dedicated to transforming clinical evaluations from a regulatory requirement into a strategic advantage. 
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