AXON Life Sciences Seminar
MDR & IVDR implementation – The transition period halfway point
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.
After the presentations there will be a panel discussion with all the speakers and Erik Raadsheer, Sr. Dir. Governmental and Regulatory Affairs and Quality Assurance EMEA at Align Technology.
Erik Vollebregt – Attorney at law at AXON Lawyers
Overview of issues, bottlenecks and opportunities halfway the transition period
Gert Bos – CTO at qservegroup and CEO at QSERVE china and at qserve Hongkong
How to work with your notified body for MDR transition
Anja Wiersma – CEO and Senior consultant at mi-CE consultancy
New performance evaluation data requirements and how to acquire those
WHEN: Wednesday 10 October 2018
WHERE: Pakhuis de Zwijger, Piet Heinkade 179, 1019 HC Amsterdam (next door to Axon office)
15.30: Registration and coffee
16.00: Start seminar
18.30: Drinks and snacks
All presentations will be in English. Attendance is free. You are welcome to bring along your colleagues. We appreciate it if you could register no later than five days before the seminar by using the button below. If you are bringing along your colleagues, add them by registering them also. Should you have any questions concerning the seminar please contact Marjon Kuijs at email@example.com or +31 88 650 6500.