We are almost at the halfway point of the transitional period of the Medical Devices Regulation (MDR) and we are well into the transitional period for the In Vitro Diagnostics Regulation (IVDR). While the contours of regulatory system are set, the EU and national implementing and guidance efforts seem to be stalling, leaving the EU’s new regulatory system for medical devices as yet unfinished. Notified bodies are in the process of obtaining their new designations under the MDR and IVDR and manufacturers face issues with availability of notified body, presently and in the future.

This seminar will discuss where we are with the roll-out of the new system and how to face the challenges that companies in the devices and IVD sectors are confronted with at this moment. Topics include the state of play of EU and national level implementation of new rules, how to work with your notified body for timely MDR and IVDR transition, gaps in clinical and performance data and a panel discussion with a devices company about how it is managing its MDR transition.

Speakers

Erik Vollebregt - Overview of issues, bottlenecks and opportunities halfway the transition period
Lawyer at Axon Lawyers

Gert Bos - How to work with your notified body for MDR transition
CTO at QserveGroup and CEO at Qserve China and at Qserve HK

Anja Wiersma - New performance evaluation data requirements and how to acquire those
CEO and Senior Consulatant at MI-CE Consultancy

PANEL DISCUSSION

With all the speakers including Erik Raadsheer Sr. Dir. Governmental and Regulatory Affairs and Quality Assurance EMEA at Align Technology

MDR/IVDR Implementation: The transition period halfway point