Aprobación en el mercado local ≠ Preparación para la UE

About this white paper

FDA or NMPA approval is a real milestone, but it doesn't automatically mean your device is ready for Europe. The EU MDR operates on a fundamentally different model, one where clinical evidence, intended purpose, risk management, and post-market obligations must form a single, coherent lifecycle narrative.

This whitepaper breaks down the most common misalignments non-EU manufacturers encounter when entering the European market: from clinical evidence gaps and classification differences to Notified Body dynamics and operational requirements. Written by regulatory and clinical experts at QbD Group, it is aimed at MedTech and digital health companies that have achieved home market approval and are now planning their EU entry strategy.

What you'll learn

• Why FDA or NMPA approval does not automatically translate to EU readiness
• How clinical evidence requirements differ under EU MDR, including data transferability and PMCF
• Why clinical strategy is typically the primary bottleneck in EU market entry
• What the role of Notified Bodies means in practice: selection, timing, and common reasons for delays
• Which operational requirements are most often underestimated, from EUDAMED to UDI and Authorised Representative obligations
• What the 2025 MDR revision proposal changes for global manufacturers