EU MDR & IVDR Certification: Navigating the Notified Body Capacity Crunch and Timeline Compression

Medical Device Global Market Access · Jan 29, 2026 · 3m

This episode delves into the ongoing Notified Body capacity crisis for EU MDR and IVDR certification. Despite extended transition deadlines, significant bottlenecks in audit scheduling and technical documentation review are creating a "timeline compression" risk. We explore why manufacturers must strategically prioritize their product portfolios and engage with Notified Bodies much earlier than planned to avoid jeopardizing market access as deadlines approach. - Why is Notified Body availability still a major risk despite MDR/IVDR deadline extensions? - What is "timeline compression" and how…