Replay: Navigating EU MDR Cardiovascular Requirements 2026 | Eclevar MedTech
Video Replay · Available

The Clinical Reviewer's Perspective: Navigating EU MDR Cardiovascular Requirements

Watch this exclusive preview with Prof. Mark DaCosta (former TÜV SÜD reviewer) and learn how to structure your clinical data to avoid rejections.

Platinum Award EUCROF 2026 Organized by Eclevar MedTech
Platinum Award EUCROF 2026
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Format Video on Demand
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Duration 45 Minutes
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Access Immediate & Free
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What You Will Learn

Move beyond theory

This session offers practical insights from those who have spent years evaluating cardiovascular files inside Notified Bodies.

Part 1

Inside the Notified Body

A deep dive into clinical files from the reviewer's perspective.

  • The most common "red flags" that lead to rejections.
  • Specific expectations for Class III devices.
Part 2

Strategic Q&A

A direct line to our experts who've been on both sides of the submission table.

  • Answers on clinical data sufficiency.
  • Managing equivalence claims under EU MDR.
The Speakers

Meet Your Experts

Prof. Mark DaCosta
Prof. Mark DaCosta
Chief Operating & Medical Officer · Former NB Team Leader

Former lead clinical reviewer at TÜV SÜD with over 400 cardiovascular dossiers evaluated. Expert in submission strategies for high-risk devices.

"A successful submission is won before it is filed. You have to anticipate the reviewer."
Chems Hachani
Chems Hachani
CEO & Founder · Moderator

Founder of Eclevar MedTech, specializing in embedding the regulatory perspective directly into clinical execution.

Reforming Clinical Evaluation of Medical Devices in Europe