EU MDR Webinar: CE Marking for Medical Devices

Apr 21, 2026

Event Overview:

The EU MDR (Medical Device Regulation) has fundamentally transformed the CE marking process for medical devices, shifting it from a documentation-focused exercise to a strategy-driven, evidence-intensive pathway. Manufacturers today face increasing scrutiny from Notified Bodies, stricter clinical evaluation requirements and longer approval timelines.

This webinar, “EU MDR CE Marking for Medical Devices: From Strategy to Approval - Insights from a Notified Body,” is designed to help you navigate this complex regulatory landscape with clarity and confidence.

Join Dr. Engin Çamer, Clinical Unit Manager at SZUTEST (Notified Body 2975), as he shares expert insights on aligning your clinical strategy, regulatory approach and technical documentation with real-world Notified Body expectations - helping you reduce delays and improve approval success rates.

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.

Still Aligning Your EU MDR Strategy?

Get clarity on what Notified Bodies actually expect - before you submit.

Still Aligning Your EU MDR Strategy?

Get clarity on what Notified Bodies actually expect - before you submit.

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