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MDR & IVDR implementation - 7 MONTHS TO DATE OF APPLICATION

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Location

Location

Pakhuis de Zwijger

179 Piet Heinkade

1019 HC Amsterdam

Netherlands

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Event description

Description

26 May 2020, the date of application of the Medical Devices Regulation (MDR) is seven months away at the date of this seminar. Yet, the MDR regulatory system is still not finished (implementing acts and guidance), essential infrastructure is still not on line (Eudamed) and conformity assessment capacity (notified bodies) is lacking. Industry and even several non-EU countries are more and more concerned about what the effect will be on the EU medical devices market. And then there is Brexit, to complicate matters even more.



Topics

This seminar will take stock of where we are with the roll-out of the MDR, what we know and what we do not know yet, what to expect and how to develop scenarios for the coming months that may make the difference between staying on the market or seeing cash flow collapse. Topics include the state of play of EU level implementation, what companies still can do and should be doing in light of the 26 May 2020 date of application as well as what the Eudamed database will look like, how to work with it and how to implement it in your organisation.

Speakers

Erik Vollebregt
PARTNER at AXON LAWYERS
The knowns and the unknowns until May 2020 - what to expect and what not to expect, and how to plan for it
Paul van Geffen and Sue Spencer
QA/RA Expert Senior Consultant respc. Head of IVD at QSERVE
The last elements of implementation before 26 May 2020
Ronald Boumans
Senior Consultant Regulatory Affairs and Person Responsible for Regulatory Compliance at Emergo by UL
Latest developments regarding Eudamed: what will it look like and how to implement it?

Information

WHEN
Wednesday
2 October 2019
WHERE
PAKHUIS DE ZWIJGER
Piet Heinkade 179
1019 HC Amsterdam
Next door to Axon office
WHAT TIME
Registration and coffee:
15.30
Start seminar:
16.00
Drinks and snacks:
18.30

RSVP

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 marjon.kuijs@axonlawyers.com or +31 88 650 6500.
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Date and Time

Location

Pakhuis de Zwijger

179 Piet Heinkade

1019 HC Amsterdam

Netherlands

View Map

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