Why One Approval Doesn't Fit All
This webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, Notified Body interactions, and lifecycle obligations.
Contents
CE marking, MDR/IVDR compliance, and market access support for medical device and IVD companies entering Europe.
Building on QbD Group's Landing in Europe MedTech whitepaper, this webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, Notified Body interactions, and lifecycle obligations.
For many MedTech companies, FDA or NMPA approval feels like the hard part is done. But when it comes to entering Europe, it is often just the beginning. Non-EU manufacturers frequently underestimate how different the regulatory and clinical expectations are under MDR and IVDR — and that gap shows up fast: in Notified Body pushback, in missing clinical evidence, and in timelines and costs that spiral out of control.
This webinar cuts through the complexity. We'll show you why EU market entry demands a fundamentally different strategy and how bringing your regulatory and clinical planning together from day one is the only reliable way to stay in control of your European launch.
向最优秀的人学习
Our speakers bring hands-on experience in EU regulatory affairs and clinical strategy for medical devices and IVDs. They will translate the complexities of MDR and IVDR into practical, actionable guidance you can apply directly to your EU market entry journey.
Business Unit Manager Regulatory Affairs - Medical Devices
Anne-Sophie Grell is Business Unit Manager Regulatory Affairs Medical Device at QbD Group, with over two decades of experience in medical physics, diagnostic imaging, and global medical device regulation. She holds a PhD in Physics and began her career as an MRI researcher in a cancer hospital before completing a Master's in Medical Physics, where she supported quality control activities across imaging and radiotherapy. In 2010, she transitioned to the private sector, taking on leadership roles in Quality and Regulatory Affairs within the medical device industry. Over the years, she has worked closely with Competent Authorities and Notified Bodies worldwide, shaping international registration strategies and regulatory pathways. At QbD, she supports manufacturers in defining and executing robust regulatory strategies to successfully bring their medical devices to the European, US, and Asian markets.
Clinical Evidence & Safety Lead
Petra is a Clinical Evidence and Safety Lead at QbD Group with over 12 years of experience across clinical practice, clinical research, and the medical device industry. She holds a Master's degree in Sports Physiotherapy and spent 10 years in clinical practice supporting both professional and non-professional athletes before transitioning into Clinical Research, where she took on roles in Clinical Operations and Safety Management. She later served as Clinical Evaluation Lead for a medical imaging device manufacturer. At QbD, Petra combines her expertise in clinical safety and evidence generation with strategic support for manufacturers in building robust clinical documentation and navigating EU MDR requirements to successfully bring their products to the European market.
Must-reads
白皮书FDA or NMPA approval doesn't mean EU readiness. Learn why home market success often leads to delays under EU MDR, and how to avoid them.
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博客FDA or NMPA approval doesn't guarantee EU readiness. Discover the key gaps MedTech companies face when transitioning to EU MDR.
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博客CE marking isn't just clinical and regulatory. Discover the hidden operational hurdles that delay EU market entry.
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