Blood, Sweat and MDR: The Raw Reality of MDR Certification

Navigating the Medical Device Regulation (MDR) certification process is a challenging journey that can make or break not only med tech startups but also established corporations. In this candid presentation, Dr. Endre Varga shares his firsthand experience of successfully guiding dicomLAB—the first Hungarian company to receive MDR certification—through this complex process, revealing the unvarnished reality behind it. He details the evolution from outsourced quality management to building an in-house team, and finally finding the right balance with a hybrid approach. The talk explores critical challenges including working with notified bodies during their own transition period, communicating MDR complexities to non-med tech investors, and maintaining business continuity during the certification process. Drawing from both successes and near-failures, Dr. Varga provides actionable insights for startups navigating MDR certification and offers recommendations for strengthening the med tech ecosystem. This presentation delivers practical wisdom for founders, investors, and industry stakeholders looking to understand the real-world implications of MDR compliance.