Navigating the EU's IVDR Maze: A Survival Guide for IVD Manufacturers with Pure Global's Expert Insights

In this episode of MedTech Global Insights, we dissect the monumental shift from Europe's IVDD to the new In Vitro Diagnostic Regulation (IVDR). We explore the seismic impact of the new risk-based classification system, which now requires Notified Body oversight for over 80% of all IVDs, a stark reversal from the previous self-certification era.

We uncover the immense challenges manufacturers face, from the critical shortage of Notified Bodies creating an industry-wide bottleneck, to the daunting requirements for generating extensive clinical evidence and implementing continuous post-market performance follow-up. This episode is an essential guide for any IVD manufacturer looking to maintain or gain access to the European market.

A Case Study in Urgency: Imagine your best-selling diagnostic test, sold in the EU for a decade under a simple self-certification, is now classified as high-risk under IVDR. Suddenly, you must produce a mountain of new clinical performance data and secure a review from a Notified Body that has no available slots for the next 18 months, all while your transition deadline looms. This is the reality for thousands of manufacturers, and we break down how to approach this high-stakes challenge.

What you'll learn in this episode:
- Why is the IVDR considered the biggest regulatory disruption for the diagnostics industry in decades?
- What does the new A-to-D risk classification *really* mean for your existing product portfolio?
- How can you develop a strategy to navigate the critical shortage of Notified Bodies?
- What are the non-negotiable requirements for your new IVDR-compliant Technical Dossier?
- Are your legacy devices still compliant, and what are the hard deadlines you absolutely cannot miss?
- What is Post-Market Performance Follow-up (PMPF), and how do you build an effective system from scratch?
- How can a streamlined regulatory approach for the EU be leveraged for faster access into other global markets?

For more information, contact us at [email protected] or visit https://pureglobal.com/