Unlocking Worldwide IVD Access with Europe's IVDR

Medical Device Global Market Access · May 28, 2025 · 4m

This episode explores how the European Union's stringent In Vitro Diagnostic Devices Regulation (IVDR) can strategically benefit IVD manufacturers seeking market access beyond the EU. We discuss leveraging IVDR CE Marking for easier entry into global markets, the role of harmonized quality management systems like ISO 13485, and the importance of a proactive global market access strategy in light of evolving international regulations, including the US FDA's QMSR effective February 2, 2026, and UK acceptance of CE marks until June 30, 2030. Key Questions: • How can the demanding EU IVDR…