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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.
Lo que aprenderás
Puntos clave de este documento
- 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
Sobre el autor
Business Unit Manager Medical Affairs
12 years of experience in the medical device field. Expert in clinical evidence and medical writing for Class I to Class III devices, including MDSW and AI-driven MDSW, as well as safety management in clinical investigations.
Sobre el autor
PhD Physics, MSc Medical Physics · Business Unit Manager RA MD
Anne-Sophie is a Regulatory Affairs leader with over two decades of experience in medical physics, diagnostic imaging, and medical device regulation. She supports clients navigating EU MDR, FDA, and international regulatory frameworks.
