EU MDR Webinar: CE Marking for Medical Devices

Apr 21, 2026

Event Overview:

Vedic Lifesciences successfully hosted the webinar EU MDR CE Marking for Medical Devices: From Strategy to Approval, an expert-led session designed to help medical device companies navigate the complexities of the evolving European regulatory landscape. The webinar provided actionable insights into the EU Medical Device Regulation (EU MDR) framework, regulatory strategy development, and the critical steps required to achieve successful CE Marking for medical devices.

As EU MDR requirements continue to reshape market access pathways, the session offered practical guidance for manufacturers, regulatory professionals, and industry stakeholders seeking a clearer route from strategy to approval.

Event Overview:

Key Discussion Points

Understanding EU MDR requirements for CE marking of medical devices

Key differences between MDD vs EU MDR compliance

Common reasons for delays in EU MDR approvals

What Notified Bodies look for in clinical evaluation and technical documentation

Strategies to strengthen your regulatory submission and clinical evidence

How to streamline your pathway to faster CE certification in Europe

Speakers

Dr. Engin Çamer, MD

Clinical Unit Manager

SZUTEST (Notified Body 2975)

Dr. Engin Çamer is a medical doctor with over 15 years of clinical experience and more than six years of expertise in Medical Device Regulation, where he has worked as an internal clinician and final clinical reviewer.

He currently serves as the Clinical Unit Manager at SZUTEST Konformitätsbewertungsstelle GmbH, a Notified Body under EU MDR. Dr. Çamer actively contributes to the European regulatory ecosystem as a member of multiple Team-NB working groups, including the Clinical Harmonization Group, Article 61(10) Working Group, Annex XVI Devices Working Group, and the Lifetime Working Group.

His experience offers a rare Notified Body perspective on how clinical evidence, regulatory strategy, and conformity assessment intersect - making this session highly valuable for organizations seeking successful CE marking under EU MDR.

This session concluded with an engaging Q&A discussion, providing attendees with practical perspectives on real-world EU MDR challenges and implementation considerations.