MDR/IVDR Implementation: The transition period halfway point

Axon Lawyers is an Amsterdam based law firm with an international orientation. Our focus is on the legal and regulatory aspects of the life sciences sector. We offer over 30 years of experience, gained as attorney at law and in-house counsel. We are familiar with the needs of small and large companies, both privately and publicly funded. Axon is a founding member of theEuropean Alliance of Life Sciences Law Firms.

Axon Lawyers

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

Pakhuis De Zwijger

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