Entering the European MedTech Market: Why One Approval Doesn't Fit All

    📅 Date: 29 April, 2026 🕐 Time: 16:00 CEST 🏷️ Topic: Medical Devices, MDR/IVDR 🌐 Language: English

    Managing regulatory and clinical risk for predictable EU entry

    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.

    FDA approval often creates a false sense of readiness

    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.

    What you'll learn

    Using real-world experience, this webinar outlines the EU market entry lifecycle — from early gap assessment to CE marking and post-market compliance — with a focus on why regulatory and clinical planning must be integrated from day one to reduce risk and control timelines and costs.

    • Understand why FDA or NMPA approval does not automatically translate into EU readiness.
    • Identify where regulatory and clinical expectations differ in Europe and how this impacts timelines and risk.
    • Learn how an integrated regulatory and clinical strategy enables more predictable EU market entry.

    Register to assess your own risks, avoid costly delays, and understand what it really takes to enter Europe successfully.

    Speakers

    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.

    Anne-Sophie Grell

    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.

    Petra De Geest

    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.