Unlocking Worldwide IVD Access with Europe's IVDR

Medical Device Global Market Access

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 actually simplify global market entry for IVD devices? • What is the significance of ISO 13485 in achieving broader international compliance? • How will the US FDA's QMSR, effective February 2, 2026, impact manufacturers with EU IVDR certification? • Which non-EU countries might recognize or streamline approvals based on an IVDR CE Mark? • Why is IVDR compliance becoming critical as legacy devices lose acceptance globally? • What are the key components of a successful global market access strategy for IVDs? • How can regulatory intelligence help IVD companies navigate complex international markets? • What opportunities does IVDR CE Marking create for accessing markets in Asia, Africa, the Middle East, and Latin America? • How long will the UK continue to recognize CE marking for market access (until June 30, 2030)? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.