• Format

    Online
    Webinar

  • Date and Time

    May 12th, 2026, 1pm CEST

  • Level

    All

  • Price

    Free

Team NB Position Paper on MDR Article 61(10)

This event is a part of our Free Webinar Series.

Clinical Evaluation without any Clinical Data is one of the most discussed and probably most underestimated parts of the MDR. Now Team NB has provided us with a Position Paper in an attempt to clarify the NBs opinion on the applicability of MDR Article 61(10) and the expectations for clinical evaluations following this route. 

In this free webinar, Engin Çamer (Clinical Unit Manager at SZUTEST Konformitätsbewertungsstelle GmbH), who is one of the authors, will present the position paper and discuss its meaning. The session will be moderated by Elisabeth Oltmanns, who's paper “Appropriateness” of Clinical Data Under Regulation (EU) 2017/745 – A Case Study and Survey has pointed out the inconsistencies in the interpretation of MDR Article 61(10) among notified bodies and who's ongoing research deals with evidence-based Clinical and Pre-Clinical Strategies for the Evaluation of Medical Devices.
Meet the Speaker

Engin ÇAMER, MD

Clinical Unit Manager
SZUTEST, Notified Body 2975

Engin Çamer, MD, is a medical doctor with over 15 years of clinical experience in emergency medicine and aviation medicine. He currently serves as the Clinical Unit Manager at SZUTEST Konformitätsbewertungsstelle GmbH. He has more than six years of experience in the field of Medical Device Regulation, working as an internal clinician and final clinical reviewer.
 
He actively contributes to the European regulatory landscape as a member of several Team-NB working groups, including Clinical Harmonisation, Article 61(10), Annex XVI Devices, and the Lifetime Working Group.

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