Past seminar

MDR/IVDR Implementation: the transition period halfway point

When

Wednesday 10 October 2018

Where

Pakhuis de Zwijger
Piet Heinkade 179 (next to the Axon office)
1019HC Amsterdam

What time

15:30 coffee and registration

16:00 start seminar

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

Attorney-at-law 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 Consultant at MI-CE Consulting

Panel discussion

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



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