Qualtech are excited to announce our first webinar in 2026: Expert Insights – EU MDR Updates 2026, where we will discuss the latest regulatory and compliance developments under the EU Medical Device Regulation (MDR) and provide expert guidance on compliance, market access, and regulatory strategies essential for MedTech success in the evolving European landscape.
Agenda
✔ MDR Transition Overview: Guidance as the transition period nears its end
✔ Streamlined Regulation: WET legislation & Notified Body requirements
✔ Revised e-IFU Regulation: Key industry implications
✔ MDR Reform: Certification timelines, recertification, PMS and innovation
✔ Coordinated Clinical Assessment: EU - wide clinical investigation approach
✔ Digitalization & EUDAMED: Confirmed timeline, mandatory core, vigilance modules
Webinar Details
▸ Date: Thursday, February 12, 2026
▸ Time: 5:00 PM (GMT+8) | 10:00 AM (CET)
▸ Language: English
▸ Registration form: https://forms.gle/HDZjiXKzpXmpTK1W7
As part of Qualtech's webinar, participants are invited to submit their MDR-related questions via the registration form. Selected questions will be addressed by our expert during the live Q&A session.
About the Speaker: Dr. Arkan Zwick
✔ Regulatory Affairs Corporate Director at Croma-Pharma GmbH, Austria
✔ More than 18 years of regulatory professional experience
✔ University of Vienna Alumni: Master's Degree in Law & PhD in European Law
✔ A Lecturer at the University of Applied Sciences in Vienna, Austria
We look forward to your participation.
For future enquiries, feel free to contact us at globalra@qualtechs.com.
