Achieving CE marking for a medical device starts with one of the most critical components in the EU regulatory process: the Technical File. But navigating the requirements of the EU MDR—and aligning your documentation with the expectations of Notified Bodies—can be complex.

In this expert-led webinar, Gsap and Dekra join forces to walk you through the essential elements of an EU MDR-compliant Technical File. From structure to strategy, the session provides practical guidance for regulatory professionals, QA teams, and innovators preparing for EU market access.

🎯 What You'll Learn:

• A step-by-step breakdown of the EU MDR Technical File structure
• Common mistakes in submissions—and how to avoid them
• What Notified Bodies really look for during document review
• How to align your file with MDR Annex II & Annex III
• Tips for building audit-ready, CE-markable documentation

Whether you're preparing your first submission or refining an existing one, this session equips you with the tools to streamline your process and increase your chances of successful EU approval.

🎥 Watch the full recording below: