EU MDR Masterclass: Expert Insights | Eclevar MedTech
🎙️ Masterclass Replay

EU MDR Masterclass:
Insights from TÜV SÜD & AKRA TEAM

The essential guide to classification, clinical data, and technical files with industry leaders.

Eclevar
TÜV SÜD
AKRA TEAM
Sneak Peek

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Featuring

HOST

Chems Hachani

CEO & Founder, Eclevar MedTech

GUEST

Julia Frese

Regulatory Expert, TÜV SÜD

GUEST

Dr. Bassil Akra

Founder & CEO, AKRA TEAM

Episode Breakdown

PART 1

The #1 Reason Devices Get Stuck

Learn why classification errors are the most common (and expensive) pitfalls in MDR.

PART 2

NBs Reject Inconsistent Files

Julia Frese details why clinical evaluation must perfectly match risk management files.

PART 3

ISO 13485 & Supplier Control

Dr. Bassil Akra explains the critical importance of global supply chain management.

Full Chapter Guide

00:00

Navigating the EU MDR Landscape

04:25

Medical Device Classification

10:11

Clinical Data Requirements

17:58

Technical File Essentials

22:22

Common Non-Conformities

37:43

Final Recommendations ⭐

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Reforming Clinical Evaluation of Medical Devices in Europe